Pharsight

1. Accrufer patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP15784705A	2018-09-05	Teva Pharmaceutical Industries Ltd	Granted and Under Opposition

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US9802973	SHIELD TX	Crystalline forms of ferric maltol	Oct, 2035 (11 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9248148	SHIELD TX	Mono (iron hydroxypyrone) and combination (iron hydroxypyrone and GI inflammation inhibiting agents) compositions for anaemia or H. pylori infections	Mar, 2031 (6 years from now)
US10179120	SHIELD TX	Dosage regimen of ferric trimaltol	Jan, 2035 (10 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jul 25, 2024

Drugs and Companies using FERRIC MALTOL ingredient

NCE-1 date: 26 July, 2023

Market Authorisation Date: 25 July, 2019

Treatment: Method of treating iron deficiency

Dosage: CAPSULE;ORAL

Strength	Dosage	Availability
30MG IRON	CAPSULE;ORAL	Prescription

ACCRUFER family patents

2. Aklief patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP13726504A	2019-04-24	Generics (U.K.) Limited	Patent maintained as amended
EP13728696A	2019-03-26	Generics (UK) Ltd	Patent maintained as amended

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7807708	GALDERMA LABS LP	Ligands that modulate RAR receptors and pharmaceutical/cosmetic compositions comprised thereof	Jul, 2031 (7 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8470871	GALDERMA LABS LP	Ligands that modulate RAR receptors	Dec, 2025 (1 year, 7 months from now)
US8227507	GALDERMA LABS LP	Ligands that modulate RAR receptors	Dec, 2025 (1 year, 7 months from now)
US9498465	GALDERMA LABS LP	Topical compositions in the form of a gel containing a particular solubilized retinoid	May, 2033 (9 years from now)
US9084778	GALDERMA LABS LP	Topical compositions containing a retinoid of the oil-in-water emulsion type	May, 2033 (9 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Oct 04, 2024

Drugs and Companies using TRIFAROTENE ingredient

NCE-1 date: 05 October, 2023

Market Authorisation Date: 04 October, 2019

Treatment: Method of activating rargamma receptor; Topical treatment of acne vulgaris; Treatment of acne vulgaris

Dosage: CREAM;TOPICAL

Strength	Dosage	Availability
0.005%	CREAM;TOPICAL	Prescription

AKLIEF family patents

3. Aubagio patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP10752585A	2018-01-04	Pentafarma Sociedade Técnico-Medicinal S.A.	Revoked
EP10752585A	2017-12-29	Wuesthoff & Wuesthoff Patentanwälte PartG mbB	Revoked
EP10752585A	2017-12-19	Cooke, Richard	Revoked

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5459163	SANOFI AVENTIS US	Medicament to combat autoimmune diseases	Oct, 2012 (11 years ago)
US5679709	SANOFI AVENTIS US	Medicaments to combat autoimmune diseases	Oct, 2014 (9 years ago)
US6794410	SANOFI AVENTIS US	Use of (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4′-trifluoromethylphenyl)-amide for treating multiple sclerosis	Sep, 2026 (2 years from now)
US6794410 (Pediatric)	SANOFI AVENTIS US	Use of (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4′-trifluoromethylphenyl)-amide for treating multiple sclerosis	Mar, 2027 (2 years from now)
US8802735	SANOFI AVENTIS US	(Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability	Sep, 2030 (6 years from now)
US8802735 (Pediatric)	SANOFI AVENTIS US	(Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability	Mar, 2031 (6 years from now)
US9186346	SANOFI AVENTIS US	Methods for reducing the risk of an adverse teriflunomide and rosuvastatin interaction in multiple sclerosis patients	Feb, 2034 (9 years from now)
US9186346 (Pediatric)	SANOFI AVENTIS US	Methods for reducing the risk of an adverse teriflunomide and rosuvastatin interaction in multiple sclerosis patients	Aug, 2034 (10 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
M(M-61)	Apr 30, 2024
Pediatric Exclusivity(PED)	Oct 30, 2024
New Chemical Entity Exclusivity(NCE)	Sep 12, 2017

Drugs and Companies using TERIFLUNOMIDE ingredient

NCE-1 date: 31 October, 2023

Market Authorisation Date: 12 September, 2012

Treatment: Treatment of patients with relapsing forms of multiple sclerosis; Treatment of patients with relapsing forms of multiple sclerosis while managing the risk of teriflunomide and rosuvastatin interaction...

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
7 mg and 14 mg	12 Sep, 2016	21	27 Jul, 2018	04 Feb, 2034	Eligible

Strength	Dosage	Availability
14MG	TABLET;ORAL	Prescription
7MG	TABLET;ORAL	Prescription

AUBAGIO family patents

4. Austedo patents expiration

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US8524733	September, 2021	Terminated-Denied	Auspex Pharmaceuticals, Inc.	Apotex Inc.

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8524733	TEVA BRANDED PHARM	Benzoquinoline inhibitors of vesicular monoamine transporter 2	Apr, 2031 (6 years from now)
US9550780	TEVA BRANDED PHARM	Formulations pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2	Sep, 2033 (9 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8524733 (Pediatric)	TEVA BRANDED PHARM	Benzoquinoline inhibitors of vesicular monoamine transporter 2	Oct, 2031 (7 years from now)
US11666566	TEVA BRANDED PHARM	Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2	Sep, 2033 (9 years from now)
US9296739	TEVA BRANDED PHARM	Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2	Sep, 2033 (9 years from now)
US9233959	TEVA BRANDED PHARM	Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2	Sep, 2033 (9 years from now)
US9814708	TEVA BRANDED PHARM	Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2	Sep, 2033 (9 years from now)
US9296739 (Pediatric)	TEVA BRANDED PHARM	Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2	Mar, 2034 (9 years from now)
US11666566 (Pediatric)	TEVA BRANDED PHARM	Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2	Mar, 2034 (9 years from now)
US9550780 (Pediatric)	TEVA BRANDED PHARM	Formulations pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2	Mar, 2034 (9 years from now)
US9814708 (Pediatric)	TEVA BRANDED PHARM	Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2	Mar, 2034 (9 years from now)
US9233959 (Pediatric)	TEVA BRANDED PHARM	Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2	Mar, 2034 (9 years from now)
US11648244	TEVA BRANDED PHARM	Methods for the treatment of abnormal involuntary movement disorders	Mar, 2036 (11 years from now)
US11446291	TEVA BRANDED PHARM	Methods for the treatment of abnormal involuntary movement disorders	Mar, 2036 (11 years from now)
US11564917	TEVA BRANDED PHARM	Methods for the treatment of abnormal involuntary movement disorders	Mar, 2036 (11 years from now)
US11357772	TEVA BRANDED PHARM	Methods for the treatment of abnormal involuntary movement disorders	Mar, 2036 (11 years from now)
US10959996	TEVA BRANDED PHARM	Methods for the treatment of abnormal involuntary movement disorders	Mar, 2036 (11 years from now)
US11446291 (Pediatric)	TEVA BRANDED PHARM	Methods for the treatment of abnormal involuntary movement disorders	Sep, 2036 (12 years from now)
US10959996 (Pediatric)	TEVA BRANDED PHARM	Methods for the treatment of abnormal involuntary movement disorders	Sep, 2036 (12 years from now)
US11648244 (Pediatric)	TEVA BRANDED PHARM	Methods for the treatment of abnormal involuntary movement disorders	Sep, 2036 (12 years from now)
US11564917 (Pediatric)	TEVA BRANDED PHARM	Methods for the treatment of abnormal involuntary movement disorders	Sep, 2036 (12 years from now)
US11357772 (Pediatric)	TEVA BRANDED PHARM	Methods for the treatment of abnormal involuntary movement disorders	Sep, 2036 (12 years from now)
US11813232	TEVA BRANDED PHARM	Analogs of deutetrabenazine, their preparation and use	Mar, 2038 (13 years from now)
US11179386	TEVA BRANDED PHARM	Analogs of deutetrabenazine, their preparation and use	Mar, 2038 (13 years from now)
US11179386 (Pediatric)	TEVA BRANDED PHARM	Analogs of deutetrabenazine, their preparation and use	Sep, 2038 (14 years from now)
US11813232 (Pediatric)	TEVA BRANDED PHARM	Analogs of deutetrabenazine, their preparation and use	Sep, 2038 (14 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-134)	Apr 03, 2024
M(M-54)	Jun 24, 2024
Pediatric Exclusivity(PED)	Dec 24, 2024
New Indication(I-751)	Aug 30, 2020
New Chemical Entity Exclusivity(NCE)	Apr 03, 2022
Orphan Drug Exclusivity(ODE)	Apr 03, 2024

Drugs and Companies using DEUTETRABENAZINE ingredient

NCE-1 date: 25 December, 2023

Market Authorisation Date: 03 April, 2017

Treatment: Treatment of tardive dyskinesia; A method of treating huntington's chorea

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
6 mg, 9 mg and 12 mg	05 Apr, 2021	2		07 Mar, 2036

Strength	Dosage	Availability
6MG	TABLET;ORAL	Prescription
12MG	TABLET;ORAL	Prescription
9MG	TABLET;ORAL	Prescription

AUSTEDO family patents

5. Balversa patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8895601	JANSSEN BIOTECH	Pyrazolyl quinoxaline kinase inhibitors	Apr, 2033 (8 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9464071	JANSSEN BIOTECH	Pyrazolyl quinoxaline kinase inhibitors	Apr, 2031 (7 years from now)
US9902714	JANSSEN BIOTECH	Quinoxaline derivatives useful as FGFR kinase modulators	Mar, 2035 (10 years from now)
US11684620	JANSSEN BIOTECH	Pharmaceutical compositions comprising N-(3,5-dimethoxyphenyl)-N′-(1-methylethyl)-N-[3-(1-methyl-1H-pyrazol-4-yl)quinoxalin-6-yl]ethane-1,2-diamine	Feb, 2036 (11 years from now)
US10898482	JANSSEN BIOTECH	Pharmaceutical compositions comprising N-(3,5-dimethoxyphenyl)-N'-1 methylethyl)-N-[3-(1-methyl-1H-pyrazol-4-yl)quinoxalin-6-yl]ethane-1,2-diamine	Feb, 2036 (11 years from now)
US11077106	JANSSEN BIOTECH	Cancer treatment	Feb, 2038 (13 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Apr 12, 2024
New Indication(I-930)	Jan 19, 2027

Drugs and Companies using ERDAFITINIB ingredient

NCE-1 date: 13 April, 2023

Market Authorisation Date: 12 April, 2019

Treatment: Treatment of adults with locally advanced or metastatic urothelial carcinoma that has susceptible fgfr3 or fgfr2 genetic alterations and progressed during or following prior platinum-containing chemot...

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
3 mg, 4 mg and 5 mg	12 Apr, 2023	1		02 Feb, 2038

Strength	Dosage	Availability
4MG	TABLET;ORAL	Prescription
3MG	TABLET;ORAL	Prescription
5MG	TABLET;ORAL	Prescription

BALVERSA family patents

6. Brukinsa patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US9447106	BEIGENE	Substituted pyrazolo[1,5-a]pyrimidines as bruton's tyrosine kinase modulators	Apr, 2034 (9 years from now)
US10927117	BEIGENE	Crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra-hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof	Aug, 2037 (13 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11142528	BEIGENE	Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators	Apr, 2034 (9 years from now)
US10570139	BEIGENE	Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators	Apr, 2034 (9 years from now)
US11591340	BEIGENE	Crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra- hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof	Aug, 2037 (13 years from now)
US11786531	BEIGENE	Methods of treating B-cell proliferative disorder	Jan, 2043 (18 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Nov 14, 2024
Orphan Drug Exclusivity(ODE-276)	Nov 14, 2026
New Indication(I-871)	Aug 31, 2024
New Indication(I-936)	Mar 07, 2027
New Indication(I-817)	Jan 19, 2026
Orphan Drug Exclusivity(ODE-274)	Jan 19, 2030
New Indication(I-874)	Sep 14, 2024
Orphan Drug Exclusivity(ODE-467)	Mar 07, 2031
Orphan Drug Exclusivity(ODE-371)	Aug 31, 2028
Orphan Drug Exclusivity(ODE-370)	Sep 14, 2028

Drugs and Companies using ZANUBRUTINIB ingredient

NCE-1 date: 15 November, 2023

Market Authorisation Date: 14 November, 2019

Treatment: Treatment of adult patients with small lymphocytic lymphoma; Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy; Treatment of adult patients with chroni...

Dosage: CAPSULE;ORAL

Strength	Dosage	Availability
80MG	CAPSULE;ORAL	Prescription

BRUKINSA family patents

7. Caplyta patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP14867061A	2022-04-27	Sandoz AG	Granted and Under Opposition

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7183282	INTRA-CELLULAR	Substituted heterocycle fused γ-carbolines	Jun, 2020 (3 years ago)
USRE39680	INTRA-CELLULAR	Substituted heterocycle fused gamma-carbolines	Jun, 2020 (3 years ago)
USRE48825	INTRA-CELLULAR	4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de]quinoxalin-8(7H)-yl)-1-(4-fluorophenyl)-1-butanone toluenesulfonic acid salt crystal forms	Mar, 2029 (4 years from now)
US9586960	INTRA-CELLULAR	4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de] quinoxalin-8(7H)-yl)-1-(4-fluorophenyl)-1-butanone toluenesulfonic acid salt crystal forms	Mar, 2029 (4 years from now)
US8648077	INTRA-CELLULAR	4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de]quinoxalin-8(7H)-yl)-1-(4-fluorophenyl)-1-butanone toluenesulfonic acid addition salt and salt crystals	Dec, 2029 (5 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10464938	INTRA-CELLULAR	Pharmaceutical compositions comprising ((6bR,10aS)-1-(4-fluorophenyl)-4-(3-methyl-2,3,6b,9,10,10a-hexahydro-1H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de]quinoxalin-8(7H)-yl)butan-1-one or pharmaceutically acceptable salts thereof	Mar, 2028 (3 years from now)
US9199995	INTRA-CELLULAR	4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de]quinoxalin-8(7H)-yl)-1-(4-fluorophenyl)-1-butanone toluenesulfonic acid addition salt and salt crystals	Mar, 2029 (4 years from now)
US9168258	INTRA-CELLULAR	Methods and compositions for sleep disorders and other disorders	May, 2029 (5 years from now)
US9616061	INTRA-CELLULAR	Methods and compositions for sleep disorders and other disorders	May, 2029 (5 years from now)
US10117867	INTRA-CELLULAR	Methods and compositions for sleep disorders and other disorders	May, 2029 (5 years from now)
US8598119	INTRA-CELLULAR	Methods and compositions for sleep disorders and other disorders	Dec, 2029 (5 years from now)
USRE48839	INTRA-CELLULAR	Methods and compositions for sleep disorders and other disorders	Aug, 2033 (9 years from now)
US9956227	INTRA-CELLULAR	Method for the treatment of residual symptoms of schizophrenia	Dec, 2034 (10 years from now)
US11026951	INTRA-CELLULAR	Methods of treating bipolar disorder	Dec, 2034 (10 years from now)
US10960009	INTRA-CELLULAR	Methods of treating schizophrenia and depression	Dec, 2034 (10 years from now)
US11052084	INTRA-CELLULAR	Pharmaceutical capsule compositions comprising lumateperone mono-tosylate	Aug, 2039 (15 years from now)
US10695345	INTRA-CELLULAR	Pharmaceutical capsule compositions comprising lumateperone mono-tosylate	Aug, 2039 (15 years from now)
US11690842	INTRA-CELLULAR	Pharmaceutical capsule compositions comprising lumateperone mono-tosylate	Aug, 2039 (15 years from now)
US11806348	INTRA-CELLULAR	Methods of treatment using pharmaceutical capsule compositions comprising lumateperone mono-tosylate	Aug, 2039 (15 years from now)
US11753419	INTRA-CELLULAR	4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de]quinoxalin-8(7H)-yl)-1-(4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H-pyrido[3′4′:4,5]pyrrolo[1,2,3-de]quinoxalin-8(7H)-yl)phenyl)butan-1-one for treating conditions of the central nervous system and cardiac disorders	Dec, 2040 (16 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Dec 20, 2024
New Indication(I-882)	Dec 17, 2024

Drugs and Companies using LUMATEPERONE TOSYLATE ingredient

NCE-1 date: 21 December, 2023

Market Authorisation Date: 22 April, 2022

Treatment: Modulation of 5-hydroxytryptamine 2 receptor activity in schizophrenia; Treatment of bipolar depression; Treatment of schizophrenia; Treatment of schizophrenia with improvement in residual symptoms of...

Dosage: CAPSULE;ORAL

Strength	Dosage	Availability
EQ 42MG BASE	CAPSULE;ORAL	Prescription
EQ 10.5MG BASE	CAPSULE;ORAL	Prescription
EQ 21MG BASE	CAPSULE;ORAL	Prescription

CAPLYTA family patents

8. Dalvance patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP03789744A	2019-07-30	Fresenius Kabi Deutschland GmbH	Granted and Under Opposition

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8143212	ABBVIE	Dalbavancin compositions for treatment of bacterial infections	Nov, 2023 (5 months ago)
US7119061	ABBVIE	Dalbavancin compositions for treatment of bacterial infections	Nov, 2023 (5 months ago)
US7115564	ABBVIE	Stable pharmaceutical compositions of dalbavancin and methods of administration	Nov, 2023 (5 months ago)
US6900175	ABBVIE	Methods of administering dalbavancin for treatment of bacterial infections	May, 2028 (4 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	May 23, 2019
New Patient Population(NPP)	Jul 22, 2024
Generating Antibiotic Incentives Now(GAIN)	May 23, 2024
New Dosing Schedule(D-154)	Jan 20, 2019

Drugs and Companies using DALBAVANCIN HYDROCHLORIDE ingredient

NCE-1 date: 24 May, 2023

Market Authorisation Date: 23 May, 2014

Treatment: Treatment of bacterial infections using a two-dose regimen of dalbavancin.; Treatment of acute bacterial skin and skin structure infections (absssi) in adult and pediatric patients using a two-dose re...

Dosage: POWDER;INTRAVENOUS

Strength	Dosage	Availability
EQ 500MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription

DALVANCE family patents

9. Exem Foam Kit patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9034300	GISKIT	Composition and method for medical imaging of body cavities	Oct, 2030 (6 years from now)
US9259494	GISKIT	Composition and method for medical imaging of body cavities	May, 2035 (11 years from now)
US9849199	GISKIT	Composition and method for medical imaging of body cavities	Feb, 2036 (11 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Nov 07, 2024

Drugs and Companies using AIR POLYMER-TYPE A ingredient

NCE-1 date: 08 November, 2023

Market Authorisation Date: 07 November, 2019

Treatment: Use in sonohysterosalpinography to assess fallopian tube patency

Dosage: FOAM;INTRAUTERINE

Strength	Dosage	Availability
10ML	FOAM;INTRAUTERINE	Prescription

EXEM FOAM KIT family patents

10. Givlaari patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP06025389A	2017-12-15	Silence Therapeutics GmbH	Revoked
EP10011217A	2017-04-13	Silence Therapeutics GmbH	Opposition rejected
EP02702247A	2010-12-10	Silence Therapeutics AG	Revoked
EP02702247A	2010-12-10	Sirna Therapeutics	Revoked
EP05002454A	2009-09-24	Silence Therapeutics AG	Granted and Under Opposition
EP05002454A	2009-09-24	ROQUES, Sarah Elizabeth	Granted and Under Opposition
EP05002454A	2009-09-23	PFIZER LIMITED	Granted and Under Opposition
EP05002454A	2009-09-23	Sanofi-Aventis Deutschland GmbH	Granted and Under Opposition
EP05002454A	2009-09-21	Sirna Therapeutics	Granted and Under Opposition
EP02710786A	2007-02-28	Sirna Therapeutics	Opposition rejected
EP02003683A	2006-03-08	atugen AG	Patent maintained as amended
EP02003683A	2006-03-08	Abbott Laboratories	Patent maintained as amended
EP02003683A	2006-03-07	Sirna Therapeutics, Inc.	Patent maintained as amended
EP02003683A	2006-03-07	Quark Biotech, Inc.	Patent maintained as amended
EP00910510A	2003-05-28	atugen AG	Revoked
EP00910510A	2003-05-28	Aventis Pharma Deutschland GmbH	Revoked
EP00910510A	2003-05-28	Grund, Martin, Dr.	Revoked
EP00910510A	2003-05-28	JANSSEN PHARMACEUTICA N.V.	Revoked
EP00910510A	2003-05-28	AstraZeneca AB	Revoked
EP00910510A	2003-05-28	Novartis AG	Revoked
EP00910510A	2003-05-28	Isis Pharmaceuticals, Inc.	Revoked
EP00910510A	2003-05-20	Sirna Therapeutics, Inc.	Revoked

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US9150605	November, 2010	Decision	Charles Allerson et al

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8546143	ALNYLAM PHARMS INC	Compositions and methods for inhibiting expression of a target gene	Jan, 2022 (2 years ago)
US9708610	ALNYLAM PHARMS INC	Compositions comprising alternating 2′-modified nucleosides for use in gene modulation	Jan, 2024 (3 months ago)
US10273477	ALNYLAM PHARMS INC	Therapeutic compositions	Mar, 2024 (a month ago)
US9708615	ALNYLAM PHARMS INC	Therapeutic compositions	Mar, 2024 (a month ago)
US11530408	ALNYLAM PHARMS INC	Therapeutic compositions	May, 2024 (21 days from now)
US9150605	ALNYLAM PHARMS INC	Compositions comprising alternating 2′-modified nucleosides for use in gene modulation	Aug, 2025 (1 year, 4 months from now)
US10131907	ALNYLAM PHARMS INC	Glycoconjugates of RNA interference agents	Aug, 2028 (4 years from now)
US8828956	ALNYLAM PHARMS INC	Carbohydrate conjugates as delivery agents for oligonucleotides	Dec, 2028 (4 years from now)
US8106022	ALNYLAM PHARMS INC	Carbohydrate conjugates as delivery agents for oligonucleotides	Dec, 2029 (5 years from now)
US10125364	ALNYLAM PHARMS INC	Compositions and methods for inhibiting expression of the ALAS1 gene	Mar, 2033 (8 years from now)
US9133461	ALNYLAM PHARMS INC	Compositions and methods for inhibiting expression of the ALAS1 gene	Nov, 2033 (9 years from now)
US10119143	ALNYLAM PHARMS INC	Compositions and methods for inhibiting expression of the ALAS1 gene	Oct, 2034 (10 years from now)
US11028392	ALNYLAM PHARMS INC	Compositions and methods for inhibiting expression of the ALAS1 gene	Oct, 2034 (10 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9631193	ALNYLAM PHARMS INC	Compositions and methods for inhibiting expression of the ALAS1 gene	Mar, 2033 (8 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Nov 20, 2024
Orphan Drug Exclusivity(ODE-273)	Nov 20, 2026

Drugs and Companies using GIVOSIRAN SODIUM ingredient

NCE-1 date: 21 November, 2023

Market Authorisation Date: 20 November, 2019

Treatment: Treatment of acute hepatic porphyria

Dosage: SOLUTION;SUBCUTANEOUS

Strength	Dosage	Availability
EQ 189MG BASE/ML (EQ 189MG BASE/ML)	SOLUTION;SUBCUTANEOUS	Prescription

GIVLAARI family patents

11. Harvoni patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP12768967A	2018-08-22	Gillard, Richard Edward	Patent maintained as amended
EP08732818A	2015-02-23	Intellectual Property Services (IPS)	Granted and Under Opposition
EP08732818A	2015-02-23	STADA Arzneimittel AG	Granted and Under Opposition
EP08732818A	2015-02-23	ZBM Patents - Zea, Barlocci & Markvardsen	Granted and Under Opposition
EP08732818A	2015-02-23	Actavis Group PTC ehf	Granted and Under Opposition
EP08732818A	2015-02-20	Pharmaceutical Works POLPHARMA	Granted and Under Opposition
EP08732818A	2015-02-20	Generics [UK] Ltd (trading as Mylan)	Granted and Under Opposition
EP08732818A	2015-02-20	Teva Pharmaceutical Industries Ltd	Granted and Under Opposition
EP08732818A	2015-02-19	Fleischer, Holm Herbert	Granted and Under Opposition
EP08732818A	2015-02-19	ELLIS IP LTD	Granted and Under Opposition
EP08732818A	2015-02-10	MEDECINS DU MONDE	Granted and Under Opposition

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US8889159	December, 2017	Terminated-Denied	Gilead Pharmasset LLC	Initiative for Medicines, Access & Knowledge (I-MAK), Inc.
US9393256	December, 2017	Terminated-Denied	Gilead Pharmasset LLC	Initiative for Medicines, Access & Knowledge (I-MAK), Inc.
US8735372	November, 2017	Institution Denied	Gilead Pharmasset LLC et al.	Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al.
US9284342	November, 2017	Institution Denied	Gilead Pharmasset LLC	Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al.
US8633309	October, 2017	Institution Denied	Gilead Pharmasset LLC	Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al.
US8334270	October, 2017	Institution Denied	Gilead Pharmasset LLC et al.	Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al.
US7964580	October, 2017	Institution Denied	Gilead Pharmasset LLC et al.	Initiative for Medicines, Access & Knowledge (I-MAK), Inc. et al.

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US9085573	GILEAD SCIENCES INC	NA	Mar, 2028 (3 years from now)
US8580765	GILEAD SCIENCES INC	NA	Mar, 2028 (3 years from now)
US8334270	GILEAD SCIENCES INC	NA	Mar, 2028 (3 years from now)
US8633309	GILEAD SCIENCES INC	Nucleoside phosphoramidates	Mar, 2029 (4 years from now)
US7964580	GILEAD SCIENCES INC	NA	Mar, 2029 (4 years from now)
US8088368	GILEAD SCIENCES INC	Antiviral compounds	May, 2030 (6 years from now)
US8822430	GILEAD SCIENCES INC	Antiviral compounds	May, 2030 (6 years from now)
US9284342	GILEAD SCIENCES INC	Nucleoside phosphoramidates	Sep, 2030 (6 years from now)
US8618076	GILEAD SCIENCES INC	Nucleoside phosphoramidates	Dec, 2030 (6 years from now)
US10039779	GILEAD SCIENCES INC	Combination formulation of two antiviral compounds	Jan, 2034 (9 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8735372	GILEAD SCIENCES INC	NA	Mar, 2028 (3 years from now)
US8580765 (Pediatric)	GILEAD SCIENCES INC	NA	Sep, 2028 (4 years from now)
US8735372 (Pediatric)	GILEAD SCIENCES INC	NA	Sep, 2028 (4 years from now)
US9085573 (Pediatric)	GILEAD SCIENCES INC	NA	Sep, 2028 (4 years from now)
US8334270 (Pediatric)	GILEAD SCIENCES INC	NA	Sep, 2028 (4 years from now)
US8889159	GILEAD SCIENCES INC	Compositions and methods for treating hepatitis C virus	Mar, 2029 (4 years from now)
US8633309 (Pediatric)	GILEAD SCIENCES INC	Nucleoside phosphoramidates	Sep, 2029 (5 years from now)
US7964580 (Pediatric)	GILEAD SCIENCES INC	NA	Sep, 2029 (5 years from now)
US8889159 (Pediatric)	GILEAD SCIENCES INC	Compositions and methods for treating hepatitis C virus	Sep, 2029 (5 years from now)
US8273341	GILEAD SCIENCES INC	Antiviral compounds	May, 2030 (6 years from now)
US9511056	GILEAD SCIENCES INC	Antiviral compounds	May, 2030 (6 years from now)
US8841278	GILEAD SCIENCES INC	Antiviral compounds	May, 2030 (6 years from now)
US8088368 (Pediatric)	GILEAD SCIENCES INC	Antiviral compounds	Nov, 2030 (6 years from now)
US8822430 (Pediatric)	GILEAD SCIENCES INC	Antiviral compounds	Nov, 2030 (6 years from now)
US8841278 (Pediatric)	GILEAD SCIENCES INC	Antiviral compounds	Nov, 2030 (6 years from now)
US9511056 (Pediatric)	GILEAD SCIENCES INC	Antiviral compounds	Nov, 2030 (6 years from now)
US8273341 (Pediatric)	GILEAD SCIENCES INC	Antiviral compounds	Nov, 2030 (6 years from now)
US9284342 (Pediatric)	GILEAD SCIENCES INC	Nucleoside phosphoramidates	Mar, 2031 (6 years from now)
US8618076 (Pediatric)	GILEAD SCIENCES INC	Nucleoside phosphoramidates	Jun, 2031 (7 years from now)
US10456414	GILEAD SCIENCES INC	Methods for treating HCV	Sep, 2032 (8 years from now)
US9393256	GILEAD SCIENCES INC	Methods for treating HCV	Sep, 2032 (8 years from now)
US9393256 (Pediatric)	GILEAD SCIENCES INC	Methods for treating HCV	Mar, 2033 (8 years from now)
US10039779 (Pediatric)	GILEAD SCIENCES INC	Combination formulation of two antiviral compounds	Jul, 2034 (10 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-136)	Apr 07, 2024
ODE(ODE)	Apr 07, 2024
Pediatric Exclusivity(PED)	Oct 07, 2024
Orphan Drug Exclusivity(ODE)	Apr 07, 2024
New Chemical Entity Exclusivity(NCE)	Oct 10, 2019
New Dosing Schedule(D-158)	Feb 12, 2019
New Dosing Schedule(D-159)	Feb 12, 2019
New Dosing Schedule(D-160)	Feb 12, 2019
New Patient Population(NPP)	Apr 07, 2020
New Indication(I-718)	Nov 12, 2018
New Dosing Schedule(D-153)	Nov 12, 2018
New Indication(I-719)	Nov 12, 2018
New Indication(I-720)	Nov 12, 2018
New Dosing Schedule(D-177)	Nov 15, 2022

Drugs and Companies using LEDIPASVIR; SOFOSBUVIR ingredient

NCE-1 date: 08 October, 2023

Market Authorisation Date: 28 August, 2019

Treatment: For the treatment of hepatitis c

Dosage: TABLET;ORAL

Strength	Dosage	Availability
90MG;400MG	TABLET;ORAL	Prescription
45MG;200MG	TABLET;ORAL	Prescription

HARVONI family patents

12. Ibsrela patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8969377	ARDELYX INC	Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders	Dec, 2029 (5 years from now)
US8541448	ARDELYX INC	Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders	Aug, 2033 (9 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9408840	ARDELYX INC	Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorder	Dec, 2029 (5 years from now)
US9006281	ARDELYX INC	Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders	May, 2030 (6 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Sep 12, 2024

Drugs and Companies using TENAPANOR HYDROCHLORIDE ingredient

NCE-1 date: 13 September, 2023

Market Authorisation Date: 12 September, 2019

Treatment: Method of treating irritable bowel syndrome with constipation by administering tenapanor

Dosage: TABLET;ORAL

Strength	Dosage	Availability
EQ 50MG BASE	TABLET;ORAL	Prescription

IBSRELA family patents

13. Inrebic patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7825246	IMPACT	Bi-aryl meta-pyrimidine inhibitors of kinases	Dec, 2026 (2 years from now)
US7528143	IMPACT	Bi-aryl meta-pyrimidine inhibitors of kinases	Nov, 2031 (7 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8138199	IMPACT	Use of bi-aryl meta-pyrimidine inhibitors of kinases	Jun, 2028 (4 years from now)
US10391094	IMPACT	Compositions and methods for treating myelofibrosis	Jun, 2032 (8 years from now)
US11400092	IMPACT	Methods of treating myeloproliferative disorders	Sep, 2039 (15 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-259)	Aug 16, 2026
New Chemical Entity Exclusivity(NCE)	Aug 16, 2024

Drugs and Companies using FEDRATINIB HYDROCHLORIDE ingredient

NCE-1 date: 17 August, 2023

Market Authorisation Date: 16 August, 2019

Treatment: Treatment of adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis; Treating adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis, monitoring...

Dosage: CAPSULE;ORAL

INREBIC family patents

14. Janumet patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US6699871	MSD SUB MERCK	Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes	Jul, 2022 (1 year, 9 months ago)
US7326708	MSD SUB MERCK	Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor	Nov, 2026 (2 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6303661	MSD SUB MERCK	Use of dipeptidyl peptidase IV effectors for lowering the blood glucose level in mammals	Apr, 2017 (7 years ago)
US7078381	MSD SUB MERCK	Method of regulating glucose metabolism, and reagents related thereto	Feb, 2019 (5 years ago)
US7459428	MSD SUB MERCK	Method of regulating glucose metabolism, and reagents related thereto	Feb, 2019 (5 years ago)
US6890898	MSD SUB MERCK	Method of regulating glucose metabolism, and reagents related thereto	Feb, 2019 (5 years ago)
US7125873	MSD SUB MERCK	Beta-amino tetrahydroimidazo (1, 2-a) pyrazines and tetrahydrotrioazolo (4, 3-a) pyrazines as dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes	Jul, 2022 (1 year, 9 months ago)
US6699871 (Pediatric)	MSD SUB MERCK	Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes	Jan, 2023 (1 year, 2 months ago)
US7125873 (Pediatric)	MSD SUB MERCK	Beta-amino tetrahydroimidazo (1, 2-a) pyrazines and tetrahydrotrioazolo (4, 3-a) pyrazines as dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes	Jan, 2023 (1 year, 2 months ago)
US7326708 (Pediatric)	MSD SUB MERCK	Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor	May, 2027 (3 years from now)
US8414921	MSD SUB MERCK	Pharmaceutical compositions of combinations of dipeptidyl peptidase-4 inhibitors with metformin	Jul, 2028 (4 years from now)
US8414921 (Pediatric)	MSD SUB MERCK	Pharmaceutical compositions of combinations of dipeptidyl peptidase-4 inhibitors with metformin	Jan, 2029 (4 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
M(M-187)	Dec 04, 2023
Pediatric Exclusivity(PED)	Jun 04, 2024
New Chemical Entity Exclusivity(NCE)	Oct 16, 2011
M(M-244)	Aug 12, 2022

Drugs and Companies using METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE ingredient

NCE-1 date: 05 June, 2023

Market Authorisation Date: 30 March, 2007

Treatment: Improvement of glycemic control in adults with type 2 diabetes mellitus; Method of treating type 2 diabetes mellitus by administering a dipeptidyl peptidase-4 inhibitor in combination with metformin a...

Dosage: TABLET;ORAL

JANUMET family patents

15. Januvia patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US6699871	MERCK SHARP DOHME	Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes	Jul, 2022 (1 year, 9 months ago)
US7326708	MERCK SHARP DOHME	Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor	Nov, 2026 (2 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6303661	MERCK SHARP DOHME	Use of dipeptidyl peptidase IV effectors for lowering the blood glucose level in mammals	Apr, 2017 (7 years ago)
US6890898	MERCK SHARP DOHME	Method of regulating glucose metabolism, and reagents related thereto	Feb, 2019 (5 years ago)
US7078381	MERCK SHARP DOHME	Method of regulating glucose metabolism, and reagents related thereto	Feb, 2019 (5 years ago)
US7459428	MERCK SHARP DOHME	Method of regulating glucose metabolism, and reagents related thereto	Feb, 2019 (5 years ago)
US7125873	MERCK SHARP DOHME	Beta-amino tetrahydroimidazo (1, 2-a) pyrazines and tetrahydrotrioazolo (4, 3-a) pyrazines as dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes	Jul, 2022 (1 year, 9 months ago)
US6699871 (Pediatric)	MERCK SHARP DOHME	Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes	Jan, 2023 (1 year, 2 months ago)
US7125873 (Pediatric)	MERCK SHARP DOHME	Beta-amino tetrahydroimidazo (1, 2-a) pyrazines and tetrahydrotrioazolo (4, 3-a) pyrazines as dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes	Jan, 2023 (1 year, 2 months ago)
US7326708 (Pediatric)	MERCK SHARP DOHME	Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor	May, 2027 (3 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
M(M-187)	Dec 04, 2023
Pediatric Exclusivity(PED)	Jun 04, 2024
New Chemical Entity Exclusivity(NCE)	Oct 16, 2011
M(M-244)	Aug 12, 2022

Drugs and Companies using SITAGLIPTIN PHOSPHATE ingredient

NCE-1 date: 05 June, 2023

Market Authorisation Date: 16 October, 2006

Treatment: Improvement of glycemic control in adults with type 2 diabetes mellitus; Improvement of glycemic control in adults with type 2 diabetes mellitus in combination with metformin and/or a ppar-gamma agoni...

Dosage: TABLET;ORAL

JANUVIA family patents

16. Kimyrsa patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US9649352	MELINTA THERAP	High purity oritavancin and method of producing same	Jul, 2035 (11 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8420592	MELINTA THERAP	Methods of treatment using single doses of oritavancin	Aug, 2029 (5 years from now)
US9682061	MELINTA THERAP	Methods of treating bacterial infections using oritavancin	Apr, 2030 (6 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Mar 12, 2024
Generating Antibiotic Incentives Now(GAIN)	Aug 06, 2024
New Chemical Entity Exclusivity(NCE)	Aug 06, 2019

Drugs and Companies using ORITAVANCIN DIPHOSPHATE ingredient

NCE-1 date: 07 August, 2023

Market Authorisation Date: 12 March, 2021

Treatment: Treatment of acute bacterial skin and skin structure infections with a single dose of 1200mg oritavancin or its single dose equivalent

Dosage: POWDER;INTRAVENOUS

KIMYRSA family patents

17. Mayzent patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7939519	NOVARTIS	Immunosuppresant compounds and compositions	Aug, 2028 (4 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8492441	NOVARTIS	Dosage regimen of an S1P receptor agonist	Nov, 2030 (6 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Mar 26, 2024
M(M-274)	Mar 01, 2025

Drugs and Companies using SIPONIMOD ingredient

NCE-1 date: 27 March, 2023

Market Authorisation Date: 26 March, 2019

Treatment: A method of treating multiple sclerosis by administering siponimod using a titration scheme to reach a maintenance dose

Dosage: TABLET;ORAL

MAYZENT family patents

18. Multrys patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11786548	AM REGENT	Trace element compositions, methods of making and use	Jul, 2041 (17 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Apr 30, 2024

Drugs and Companies using CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE ingredient

NCE-1 date: 01 May, 2023

Market Authorisation Date: 30 June, 2021

Treatment: NA

Dosage: SOLUTION;INTRAVENOUS

MULTRYS family patents

19. Myrbetriq patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US6346532	APGDI	Amide derivatives or salts thereof	Mar, 2022 (2 years ago)
US7342117	APGDI	α-form or β-form crystal of acetanilide derivative	Nov, 2023 (5 months ago)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6699503	APGDI	Hydrogel-forming sustained-release preparation	Sep, 2013 (10 years ago)
US6562375	APGDI	Stable pharmaceutical composition for oral use	Aug, 2020 (3 years ago)
US6346532 (Pediatric)	APGDI	Amide derivatives or salts thereof	Sep, 2022 (1 year, 6 months ago)
US7982049	APGDI	α-form or β-form crystal of acetanilide derivative	Nov, 2023 (5 months ago)
USRE44872	APGDI	Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient	Nov, 2023 (5 months ago)
US8835474	APGDI	Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient	Nov, 2023 (5 months ago)
US7750029	APGDI	Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient	Dec, 2023 (4 months ago)
US7342117 (Pediatric)	APGDI	α-form or β-form crystal of acetanilide derivative	May, 2024 (7 days from now)
USRE44872 (Pediatric)	APGDI	Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient	May, 2024 (7 days from now)
US7982049 (Pediatric)	APGDI	α-form or β-form crystal of acetanilide derivative	May, 2024 (7 days from now)
US8835474 (Pediatric)	APGDI	Remedy for overactive bladder comprising acetic acid anilide derivative as the active ingredient	May, 2024 (7 days from now)
US8772315	APGDI	Pharmaceutical composition for treating overactive bladder	Oct, 2028 (4 years from now)
US8772315 (Pediatric)	APGDI	Pharmaceutical composition for treating overactive bladder	Apr, 2029 (5 years from now)
US11707451	APGDI	Pharmaceutical composition for modified release	Sep, 2029 (5 years from now)
US10842780	APGDI	Pharmaceutical composition for modified release	Sep, 2029 (5 years from now)
US10842780 (Pediatric)	APGDI	Pharmaceutical composition for modified release	Mar, 2030 (5 years from now)
US11707451 (Pediatric)	APGDI	Pharmaceutical composition for modified release	Mar, 2030 (5 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication(I-855)	Mar 25, 2024
Pediatric Exclusivity(PED)	Sep 25, 2024
New Indication(I-777)	Apr 27, 2021
New Chemical Entity Exclusivity(NCE)	Jun 28, 2017

Drugs and Companies using MIRABEGRON ingredient

NCE-1 date: 26 September, 2023

Market Authorisation Date: 28 June, 2012

Treatment: For the treatment of overactive bladder (oab) with symptoms of urge urinary incontinence, urgency, and urinary frequency; Treatment of overactive bladder with symptoms of urge urinary incontinence, ur...

Dosage: TABLET, EXTENDED RELEASE;ORAL

MYRBETRIQ family patents

20. Nourianz patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7541363	KYOWA KIRIN	Microcrystal	Nov, 2024 (6 months from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7727994	KYOWA KIRIN	Methods of treating patients suffering from movement disorders	Jan, 2023 (1 year, 3 months ago)
US8318201	KYOWA KIRIN	Method of stabilizing diarylvinylene compound	Sep, 2027 (3 years from now)
US7727993	KYOWA KIRIN	Administering adenosine A2A receptor antagonist to reduce or suppress side effects of parkinson's disease therapy	Jan, 2028 (3 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Aug 27, 2024

Drugs and Companies using ISTRADEFYLLINE ingredient

NCE-1 date: 28 August, 2023

Market Authorisation Date: 27 August, 2019

Treatment: A method of reducing off time from l-dopa therapy, comprising administering, to a human patient with parkinson's disease, an effective amount of istradefylline, wherein the patient currently receives ...

Dosage: TABLET;ORAL

NOURIANZ family patents

21. Nubeqa patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US11046713	BAYER HEALTHCARE	Androgen receptor modulating compounds	Oct, 2030 (6 years from now)
US10711013	BAYER HEALTHCARE	Androgen receptor modulating compounds	Oct, 2030 (6 years from now)
US9657003	BAYER HEALTHCARE	Androgen receptor modulating compounds	Oct, 2030 (6 years from now)
US8975254	BAYER HEALTHCARE	Androgen receptor modulating compounds	Mar, 2033 (8 years from now)
US10383853	BAYER HEALTHCARE	Carboxamide derivative and its diastereomers in stable crystalline form	Jan, 2036 (11 years from now)
US10010530	BAYER HEALTHCARE	Carboxamide derivative and its diastereomers in stable crystalline form	Jan, 2036 (11 years from now)
US11168058	BAYER HEALTHCARE	Manufacture of a crystalline pharmaceutical product	Feb, 2038 (13 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10835515	BAYER HEALTHCARE	Carboxamide derivative and its diastereomers in stable crystalline form	Jan, 2036 (11 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jul 30, 2024
New Indication(I-900)	Aug 05, 2025

Drugs and Companies using DAROLUTAMIDE ingredient

NCE-1 date: 31 July, 2023

Market Authorisation Date: 30 July, 2019

Treatment: Treatment of patients with non-metastatic castration resistant prostate cancer

Dosage: TABLET;ORAL

NUBEQA family patents

22. Orbactiv patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US5998581	MELINTA THERAP	Reductive alkylation of glycopeptide antibiotics	Nov, 2017 (6 years ago)
US5840684	MELINTA THERAP	Glycopeptide antibiotic derivatives	Nov, 2020 (3 years ago)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8420592	MELINTA THERAP	Methods of treatment using single doses of oritavancin	Aug, 2029 (5 years from now)
US9682061	MELINTA THERAP	Methods of treating bacterial infections using oritavancin	Apr, 2030 (6 years from now)
US9649352	MELINTA THERAP	High purity oritavancin and method of producing same	Jul, 2035 (11 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Aug 06, 2019
Generating Antibiotic Incentives Now(GAIN)	Aug 06, 2024

Drugs and Companies using ORITAVANCIN DIPHOSPHATE ingredient

NCE-1 date: 07 August, 2023

Market Authorisation Date: 06 August, 2014

Treatment: Treatment of bacterial skin and skin structure infections using a single dose; Treatment of bacterial skin and skin structure infections

Dosage: POWDER;INTRAVENOUS

ORBACTIV family patents

23. Oxbryta patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US10034879	GLOBAL BLOOD THERAPS	Substituted benzaldehyde compounds and methods for their use in increasing tissue oxygenation	Dec, 2032 (8 years from now)
US10806733	GLOBAL BLOOD THERAPS	Substituted benzaldehyde compounds and methods for their use in increasing tissue oxygenation	Dec, 2032 (8 years from now)
US9018210	GLOBAL BLOOD THERAPS	Substituted benzaldehyde compounds and methods for their use in increasing tissue oxygenation	Nov, 2033 (9 years from now)
US9447071	GLOBAL BLOOD THERAPS	Crystalline polymorphs of the free base of 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde	Feb, 2035 (10 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10017491	GLOBAL BLOOD THERAPS	Compounds and uses thereof for the modulation of hemoglobin	Dec, 2032 (8 years from now)
US9248199	GLOBAL BLOOD THERAPS	1:1 adducts of sickle hemoglobin	Jan, 2034 (9 years from now)
US11452720	GLOBAL BLOOD THERAPS	Crystalline polymorphs of the free base of 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde	Feb, 2035 (10 years from now)
US10722502	GLOBAL BLOOD THERAPS	Crystalline polymorphs of the free base of 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde	Feb, 2035 (10 years from now)
US11020382	GLOBAL BLOOD THERAPS	Dosing regimens for 2-hydroxy-6-((2-(1-isopropyl-1h-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde	Dec, 2036 (12 years from now)
US10493035	GLOBAL BLOOD THERAPS	Tablets comprising 2-hydroxy-6-((2-(1-isopropyl-1H-pyrazol-5-yl)pyridin-3-yl)methoxy)benzaldehyde	Oct, 2037 (13 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-281)	Nov 25, 2026
New Chemical Entity Exclusivity(NCE)	Nov 25, 2024
Orphan Drug Exclusivity(ODE-394)	Dec 17, 2028

Drugs and Companies using VOXELOTOR ingredient

NCE-1 date: 26 November, 2023

Market Authorisation Date: 14 October, 2022

Treatment: Treatment of sickle cell disease by administering voxelotor, as recited in claim 2; Treating sickle cell disease by administering voxelotor and another active agent; Increasing hemoglobin to treat sic...

Dosage: TABLET;ORAL

OXBRYTA family patents

24. Piqray patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8476268	NOVARTIS	Pyrrolidine-1,2-dicarboxamide derivatives	Sep, 2029 (5 years from now)
US8227462	NOVARTIS	Pyrrolidine-1,2-dicarboxamide derivatives	Apr, 2033 (9 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	May 24, 2024
New Indication(I-937)	Jan 18, 2027

Drugs and Companies using ALPELISIB ingredient

NCE-1 date: 25 May, 2023

Market Authorisation Date: 24 May, 2019

Treatment: In combination with fulvestrant for treatment of postmenopausal women, and men, with hr-positive, her-2-negative, pik3ca-mutated, advanced or metastatic breast cancer

Dosage: TABLET;ORAL

PIQRAY family patents

25. Pradaxa patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US6087380	BOEHRINGER INGELHEIM	Disubstituted bicyclic heterocycles, the preparations and the use thereof as pharmaceutical compositions	Dec, 2021 (2 years ago)
US7932273	BOEHRINGER INGELHEIM	3-[(2-{[4-(hexyloxycarbonylaminoiminomethyl) phenylamino]methyl}-1-methyl-1H-benzimidazol-5-carbonyl)pyridin-2-ylamino]propionic acid ethylester methansulfonate and its use as a medicament	Sep, 2025 (1 year, 4 months from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6087380 (Pediatric)	BOEHRINGER INGELHEIM	Disubstituted bicyclic heterocycles, the preparations and the use thereof as pharmaceutical compositions	Jun, 2022 (1 year, 9 months ago)
US9925174	BOEHRINGER INGELHEIM	Administration form for the oral application of 3-[(2-{[4-(hexyloxycarbonyl-amino-imino-methyl)-phenylamino]-methyl}-1-methyl-1 H-benzimidazol acid ethyl ester and the salts thereof	Jun, 2023 (10 months ago)
US9925174 (Pediatric)	BOEHRINGER INGELHEIM	Administration form for the oral application of 3-[(2-{[4-(hexyloxycarbonyl-amino-imino-methyl)-phenylamino]-methyl}-1-methyl-1 H-benzimidazol acid ethyl ester and the salts thereof	Dec, 2023 (4 months ago)
US7932273 (Pediatric)	BOEHRINGER INGELHEIM	3-[(2-{[4-(hexyloxycarbonylaminoiminomethyl) phenylamino]methyl}-1-methyl-1H-benzimidazol-5-carbonyl)pyridin-2-ylamino]propionic acid ethylester methansulfonate and its use as a medicament	Mar, 2026 (1 year, 10 months from now)
US7866474	BOEHRINGER INGELHEIM	Film container	Aug, 2027 (3 years from now)
US7866474 (Pediatric)	BOEHRINGER INGELHEIM	Film container	Mar, 2028 (3 years from now)
US9034822	BOEHRINGER INGELHEIM	Methods of using antibodies during anticoagulant therapy of dabigatran and/or related compounds	Jan, 2031 (6 years from now)
US9034822 (Pediatric)	BOEHRINGER INGELHEIM	Methods of using antibodies during anticoagulant therapy of dabigatran and/or related compounds	Jul, 2031 (7 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication(I-862)	Jun 21, 2024
Pediatric Exclusivity(PED)	Dec 21, 2024
New Indication(I-683)	Apr 04, 2017
New Indication(I-682)	Apr 04, 2017
New Strength(NS)	Nov 20, 2018
M(M-168)	Nov 20, 2018
New Chemical Entity Exclusivity(NCE)	Oct 19, 2015

Drugs and Companies using DABIGATRAN ETEXILATE MESYLATE ingredient

NCE-1 date: 22 December, 2023

Market Authorisation Date: 19 October, 2010

Treatment: Method of reversing the anticoagulant effect of dabigatran using idarucizumab; Prophylaxis or treatment of venous and arterial thrombotic disease

Dosage: CAPSULE;ORAL

PRADAXA family patents

26. Rinvoq patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
USRE47221	ABBVIE	Tricyclic compounds	Dec, 2030 (6 years from now)
US8962629	ABBVIE	Tricyclic compounds	Jan, 2031 (6 years from now)
US11186584	ABBVIE	Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof	Oct, 2036 (12 years from now)
US10981923	ABBVIE	Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[l,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof	Oct, 2036 (12 years from now)
US9951080	ABBVIE	Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-alpha]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof	Oct, 2036 (12 years from now)
US11680069	ABBVIE	Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof	Oct, 2036 (12 years from now)
US11718627	ABBVIE	Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof	Oct, 2036 (12 years from now)
US11661425	ABBVIE	Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof	Oct, 2036 (12 years from now)
US11773105	ABBVIE	Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]- pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof	Oct, 2036 (12 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11773106	ABBVIE	Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof	Oct, 2036 (12 years from now)
US11535625	ABBVIE	Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof	Oct, 2036 (12 years from now)
US11198697	ABBVIE	Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof	Oct, 2036 (12 years from now)
US10519164	ABBVIE	Processes for the preparation of (3S,4R)-3,ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof	Oct, 2036 (12 years from now)
US10730883	ABBVIE	Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof	Oct, 2036 (12 years from now)
US10981924	ABBVIE	Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof	Oct, 2036 (12 years from now)
US9963459	ABBVIE	Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-alpla]pyrrolo[2,3-e]-pyrazin-8-YL)-N-(2,2,2-Trifluoroethyl)pyrrol and solid state forms thereof	Oct, 2036 (12 years from now)
US11795175	ABBVIE	Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof	Oct, 2036 (12 years from now)
US11535624	ABBVIE	Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-α]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof	Oct, 2036 (12 years from now)
US11535626	ABBVIE	Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1 carboxamide and solid state forms thereof	Oct, 2036 (12 years from now)
US11780847	ABBVIE	Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1- carboxamide and solid state forms thereof	Oct, 2036 (12 years from now)
US11767326	ABBVIE	Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof	Oct, 2036 (12 years from now)
US11787815	ABBVIE	Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof	Oct, 2036 (12 years from now)
US10995095	ABBVIE	Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carb oxamide and solid state forms thereof	Oct, 2036 (12 years from now)
US11524964	ABBVIE	Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof	Oct, 2036 (12 years from now)
US10202393	ABBVIE	Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-α]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof	Oct, 2036 (12 years from now)
US10344036	ABBVIE	Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-#a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-#carboxamide and solid state forms thereof	Oct, 2036 (12 years from now)
US11780848	ABBVIE	Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1- carboxamide and solid state forms thereof	Oct, 2036 (12 years from now)
US11512092	ABBVIE	Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof	Oct, 2036 (12 years from now)
US11365198	ABBVIE	Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof	Oct, 2036 (12 years from now)
US10597400	ABBVIE	Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carb oxamide and solid state forms thereof	Oct, 2036 (12 years from now)
US10550126	ABBVIE	Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-A]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof	Oct, 2036 (12 years from now)
US11564922	ABBVIE	Methods of treating crohn's disease and ulcerative colitis	Mar, 2038 (13 years from now)
US11607411	ABBVIE	Methods of treating Crohn's disease and ulcerative colitis	Mar, 2038 (13 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Aug 16, 2024
New Indication(I-919)	May 18, 2026
New Indication(I-886)	Mar 16, 2025
New Indication(I-888)	Apr 29, 2025
New Indication(I-880)	Dec 14, 2024
New Indication(I-883)	Jan 14, 2025

Drugs and Companies using UPADACITINIB ingredient

NCE-1 date: 17 August, 2023

Market Authorisation Date: 16 August, 2019

Treatment: Treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more tnf blockers; Treatment of adults and pediatric patients 12 years of age and ol...

Dosage: TABLET, EXTENDED RELEASE;ORAL

RINVOQ family patents

27. Rozlytrek patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US9029356	GENENTECH INC	Substituted indazole derivatives active as kinase inhibitors	Jul, 2028 (4 years from now)
US8299057	GENENTECH INC	Substituted indazole derivatives active as kinase inhibitors	Mar, 2029 (4 years from now)
US9085565	GENENTECH INC	Process for the preparation of N-[5-(3,5-difluoro-benzyl)-1H-indazol-3-yl]-4-(4-methyl-piperazin-1-yl)-2-(tetrahydro-pyran-4-ylamino)-benzamide	May, 2033 (9 years from now)
US10738037	GENENTECH INC	Crystalline form of N-[5-(3,5-difluoro-benzyl)-1H-indazol-3-yl]-4-(4-methyl-piperazin-1-yl)-2-(tetrahydro-pyran-4-ylamino)-benzamide	May, 2037 (13 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9255087	GENENTECH INC	Substituted indazole derivatives active as kinase inhibitors	Jul, 2028 (4 years from now)
US9616059	GENENTECH INC	Substituted indazole derivatives active as kinase inhibitors	Jul, 2028 (4 years from now)
US9085558	GENENTECH INC	Substituted indazole derivatives active as kinase inhibitors	Jul, 2028 (4 years from now)
US8673893	GENENTECH INC	Substituted indazole derivatives active as kinase inhibitors	Jul, 2028 (4 years from now)
US9649306	GENENTECH INC	Treatment of diseases through administration of N-[5-(3,5-difluoro-benzyl)-1H-indazol-3-yl]-4-(4-methyl-piperazin-1-yl)-2-(tetrahydro-pyran-4-ylamino)-benzamide	May, 2033 (9 years from now)
US10231965	GENENTECH INC	Molecules for administration to ROS1 mutant cancer cells	Feb, 2035 (10 years from now)
US10561651	GENENTECH INC	Methods for treating neuroblastoma	Feb, 2035 (10 years from now)
US11091469	GENENTECH INC	Crystalline form of N-[5-(3,5-difluoro-benzyl)-1H-indazol-3-yl]-4-(4-methyl-piperazin-1-yl)-2-(tetrahydro-pyran-4-ylamino)-benzamide	May, 2037 (13 years from now)
US10398693	GENENTECH INC	Pharmaceutical compositions and dosage forms	Jul, 2038 (14 years from now)
US11253515	GENENTECH INC	Pharmaceutical compositions and dosage forms	Jul, 2038 (14 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-265)	Aug 15, 2026
New Chemical Entity Exclusivity(NCE)	Aug 15, 2024
Orphan Drug Exclusivity(ODE-313)	Aug 15, 2026
New Patient Population(NPP)	Oct 20, 2026
Orphan Drug Exclusivity(ODE-448)	Oct 20, 2030

Drugs and Companies using ENTRECTINIB ingredient

NCE-1 date: 16 August, 2023

Market Authorisation Date: 15 August, 2019

Treatment: Treatment of ros1-positive non-small cell lung cancer; Treatment of solid tumors that have a neurotrophic tyrosine receptor kinase (ntrk) gene fusion; Treatment of neuroblastomas that have a neurotrop...

Dosage: CAPSULE;ORAL

ROZLYTREK family patents

28. Scenesse patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10076555	CLIVUNEL INC	Methods of inducing melanogenesis in a subject	Feb, 2025 (9 months from now)
US8334265	CLIVUNEL INC	Method of treatment of photodermatoses	Mar, 2029 (4 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-270)	Oct 08, 2026
New Chemical Entity Exclusivity(NCE)	Oct 08, 2024

Drugs and Companies using AFAMELANOTIDE ingredient

NCE-1 date: 09 October, 2023

Market Authorisation Date: 08 October, 2019

Treatment: Increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (epp)

Dosage: IMPLANT;SUBCUTANEOUS

SCENESSE family patents

29. Sivextro patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8420676	CUBIST PHARMS LLC	Oxazolidinone derivatives	Feb, 2028 (3 years from now)
US7816379	CUBIST PHARMS LLC	Oxazolidinone derivatives	Jun, 2028 (4 years from now)
US10442829	CUBIST PHARMS LLC	Forms of R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate	Feb, 2030 (5 years from now)
US9624250	CUBIST PHARMS LLC	Forms of R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate	Feb, 2030 (5 years from now)
US8426389	CUBIST PHARMS LLC	Crystalline form of R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate	Dec, 2030 (6 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9988406	CUBIST PHARMS LLC	Forms of R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate	Feb, 2030 (5 years from now)
US10065947	CUBIST PHARMS LLC	Forms of R)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate	Feb, 2030 (5 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jun 20, 2019
Generating Antibiotic Incentives Now(GAIN)	Jun 20, 2024
New Patient Population(NPP)	Jun 19, 2023

Drugs and Companies using TEDIZOLID PHOSPHATE ingredient

NCE-1 date: 21 June, 2023

Market Authorisation Date: 20 June, 2014

Treatment: Method of treating bacterial infections; Method of treating acute bacterial skin and skin structure infections (absssi) caused by designated susceptible bacteria

Dosage: POWDER;INTRAVENOUS; TABLET;ORAL

SIVEXTRO family patents

30. Sovaldi patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8334270	GILEAD SCIENCES INC	NA	Mar, 2028 (3 years from now)
US9085573	GILEAD SCIENCES INC	NA	Mar, 2028 (3 years from now)
US8580765	GILEAD SCIENCES INC	NA	Mar, 2028 (3 years from now)
US8633309	GILEAD SCIENCES INC	Nucleoside phosphoramidates	Mar, 2029 (4 years from now)
US7964580	GILEAD SCIENCES INC	NA	Mar, 2029 (4 years from now)
US9284342	GILEAD SCIENCES INC	Nucleoside phosphoramidates	Sep, 2030 (6 years from now)
US8618076	GILEAD SCIENCES INC	Nucleoside phosphoramidates	Dec, 2030 (6 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9085573 (Pediatric)	GILEAD SCIENCES INC	NA	Sep, 2028 (4 years from now)
US8580765 (Pediatric)	GILEAD SCIENCES INC	NA	Sep, 2028 (4 years from now)
US8334270 (Pediatric)	GILEAD SCIENCES INC	NA	Sep, 2028 (4 years from now)
US8889159	GILEAD SCIENCES INC	Compositions and methods for treating hepatitis C virus	Mar, 2029 (4 years from now)
US9549941	GILEAD SCIENCES INC	Compositions and methods for treating hepatitis C virus	Mar, 2029 (4 years from now)
US7964580 (Pediatric)	GILEAD SCIENCES INC	NA	Sep, 2029 (5 years from now)
US8633309 (Pediatric)	GILEAD SCIENCES INC	Nucleoside phosphoramidates	Sep, 2029 (5 years from now)
US9549941 (Pediatric)	GILEAD SCIENCES INC	Compositions and methods for treating hepatitis C virus	Sep, 2029 (5 years from now)
US8889159 (Pediatric)	GILEAD SCIENCES INC	Compositions and methods for treating hepatitis C virus	Sep, 2029 (5 years from now)
US9284342 (Pediatric)	GILEAD SCIENCES INC	Nucleoside phosphoramidates	Mar, 2031 (6 years from now)
US8618076 (Pediatric)	GILEAD SCIENCES INC	Nucleoside phosphoramidates	Jun, 2031 (7 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-135)	Apr 07, 2024
ODE(ODE)	Aug 28, 2026
Pediatric Exclusivity(PED)	Oct 07, 2024
New Patient Population(NPP)	Apr 07, 2020
Orphan Drug Exclusivity(ODE)	Apr 07, 2024
New Chemical Entity Exclusivity(NCE)	Dec 06, 2018

Drugs and Companies using SOFOSBUVIR ingredient

NCE-1 date: 08 October, 2023

Market Authorisation Date: 28 August, 2019

Treatment: For the treatment of hepatitis c; For the treatment of genotype 1, 2, 3 or 4 chronic hepatitis c virus (hcv) infection as a component of a combination antiviral treatment regimen with ribavirin

Dosage: TABLET;ORAL

SOVALDI family patents

31. Sunosi patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8877806	AXSOME MALTA	Treatment of sleep-wake disorders	Jun, 2026 (2 years from now)
US10351517	AXSOME MALTA	Treatment of sleep-wake disorders	Jun, 2026 (2 years from now)
US11753368	AXSOME MALTA	Treatment of sleep-wake disorders	Jun, 2026 (2 years from now)
US9604917	AXSOME MALTA	Treatment of sleep-wake disorders	Jun, 2026 (2 years from now)
US8440715	AXSOME MALTA	Treatment of sleep-wake disorders	Jun, 2031 (7 years from now)
US11439597	AXSOME MALTA	Formulations of (R)-2-amino-3-phenylpropyl carbamate	Sep, 2037 (13 years from now)
US10195151	AXSOME MALTA	Formulations of (R)-2-amino-3-phenylpropyl carbamate	Sep, 2037 (13 years from now)
US10512609	AXSOME MALTA	Formulations of (R)-2-amino-3-phenylpropyl carbamate	Sep, 2037 (13 years from now)
US11648232	AXSOME MALTA	Methods and compositions for treating excessive sleepiness	Jun, 2038 (14 years from now)
US10959976	AXSOME MALTA	Methods and compositions for treating excessive sleepiness	Jun, 2038 (14 years from now)
US10912754	AXSOME MALTA	Methods and compositions for treating excessive sleepiness	Jun, 2038 (14 years from now)
US11560354	AXSOME MALTA	Compositions comprising (R)-2-amino-3-phenylpropyl carbamate and uses thereof	Mar, 2039 (14 years from now)
US11160779	AXSOME MALTA	Methods of providing solriamfetol therapy to subjects with impaired renal function	Mar, 2040 (15 years from now)
US11850226	AXSOME MALTA	Methods of providing solriamfetol therapy to subjects with impaired renal function	Mar, 2040 (15 years from now)
US11850228	AXSOME MALTA	Methods of providing solriamfetol therapy to subjects with impaired renal function	Mar, 2040 (15 years from now)
US11839598	AXSOME MALTA	Methods of providing solriamfetol therapy to subjects with impaired renal function	Mar, 2040 (15 years from now)
US11850227	AXSOME MALTA	Methods of providing solriamfetol therapy to subjects with impaired renal function	Mar, 2040 (15 years from now)
US10940133	AXSOME MALTA	Methods of providing solriamfetol therapy to subjects with impaired renal function	Mar, 2040 (15 years from now)
US11839599	AXSOME MALTA	Methods of providing solriamfetol therapy to subjects with impaired renal function	Mar, 2040 (15 years from now)
US11771666	AXSOME MALTA	Methods of administering solriamfetol to lactating women	Dec, 2042 (18 years from now)
US11779554	AXSOME MALTA	Methods of administering solriamfetol to lactating women	Dec, 2042 (18 years from now)
US11793776	AXSOME MALTA	Methods of administering solriamfetol to lactating women	Dec, 2042 (18 years from now)
US11771667	AXSOME MALTA	Methods of administering solriamfetol to lactating women	Dec, 2042 (18 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jun 17, 2024
Orphan Drug Exclusivity(ODE-254)	Jun 17, 2026

Drugs and Companies using SOLRIAMFETOL HYDROCHLORIDE ingredient

NCE-1 date: 18 June, 2023

Market Authorisation Date: 17 June, 2019

Treatment: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (osa); Treatment of excessive daytime sleepiness with a dosing regimen ...

Dosage: TABLET;ORAL

SUNOSI family patents

32. Toviaz patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7384980	PFIZER	Derivatives of 3,3-diphenylpropylamines	May, 2019 (4 years ago)
US7985772	PFIZER	Derivatives of 3,3-diphenylpropylamines	May, 2019 (4 years ago)
US8338478	PFIZER	Derivatives of 3,3-diphenylpropylamines	May, 2019 (4 years ago)
US6858650	PFIZER	Stable salts of novel derivatives of 3,3-diphenylpropylamines	Jul, 2022 (1 year, 9 months ago)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7855230	PFIZER	Derivatives of 3,3-diphenylpropylamines	May, 2019 (4 years ago)
US6858650 (Pediatric)	PFIZER	Stable salts of novel derivatives of 3,3-diphenylpropylamines	Jan, 2023 (1 year, 3 months ago)
US7807715	PFIZER	Pharmaceutical compositions comprising fesoterodine	Jun, 2027 (3 years from now)
US8088398	PFIZER	Pharmaceutical compositions comprising fesoterodine	Jun, 2027 (3 years from now)
US8501723	PFIZER	Pharmaceutical compositions comprising fesoterodine	Jun, 2027 (3 years from now)
US7807715 (Pediatric)	PFIZER	Pharmaceutical compositions comprising fesoterodine	Dec, 2027 (3 years from now)
US8501723 (Pediatric)	PFIZER	Pharmaceutical compositions comprising fesoterodine	Dec, 2027 (3 years from now)
US8088398 (Pediatric)	PFIZER	Pharmaceutical compositions comprising fesoterodine	Dec, 2027 (3 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Indication(I-861)	Jun 17, 2024
Pediatric Exclusivity(PED)	Dec 17, 2024
New Chemical Entity Exclusivity(NCE)	Oct 31, 2013

Drugs and Companies using FESOTERODINE FUMARATE ingredient

NCE-1 date: 18 December, 2023

Market Authorisation Date: 31 October, 2008

Treatment: Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency

Dosage: TABLET, EXTENDED RELEASE;ORAL

TOVIAZ family patents

33. Tralement patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11786548	AM REGENT	Trace element compositions, methods of making and use	Jul, 2041 (17 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Apr 30, 2024

Drugs and Companies using CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE ingredient

NCE-1 date: 01 May, 2023

Market Authorisation Date: 30 June, 2021

Treatment: NA

Dosage: SOLUTION;INTRAVENOUS

TRALEMENT family patents

34. Trikafta (copackaged) patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8754224	VERTEX PHARMS INC	Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide	Dec, 2026 (2 years from now)
US11639347	VERTEX PHARMS INC	Modulators of ATP-binding cassette transporters	Apr, 2027 (2 years from now)
US10239867	VERTEX PHARMS INC	Modulators of ATP-binding cassette transporters	Apr, 2027 (2 years from now)
US7645789	VERTEX PHARMS INC	Indole derivatives as CFTR modulators	May, 2027 (3 years from now)
US8623905	VERTEX PHARMS INC	Modulators of ATP-binding cassette transporters	May, 2027 (3 years from now)
US7495103	VERTEX PHARMS INC	Modulators of ATP-binding cassette transporters	May, 2027 (3 years from now)
US7776905	VERTEX PHARMS INC	Modulators of ATP-binding cassette transporters	Jun, 2027 (3 years from now)
US11426407	VERTEX PHARMS INC	Modulators of cystic fibrosis transmembrane conductance regulator	Oct, 2035 (11 years from now)
US10758534	VERTEX PHARMS INC	NA	Oct, 2035 (11 years from now)
US11453655	VERTEX PHARMS INC	Modulator of the cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator	Dec, 2037 (13 years from now)
US10793547	VERTEX PHARMS INC	Modulator of the cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator	Dec, 2037 (13 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8629162	VERTEX PHARMS INC	Modulators of ATP-binding cassette transporters	Jun, 2025 (1 year, 1 month from now)
US8354427	VERTEX PHARMS INC	Modulators of ATP-binding cassette transporters	Jul, 2026 (2 years from now)
US9670163	VERTEX PHARMS INC	Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide	Dec, 2026 (2 years from now)
US9931334	VERTEX PHARMS INC	Solid forms of N[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide	Dec, 2026 (2 years from now)
US8410274	VERTEX PHARMS INC	Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide	Dec, 2026 (2 years from now)
US10022352	VERTEX PHARMS INC	Modulators of ATP-binding cassette transporters	Apr, 2027 (2 years from now)
US9974781	VERTEX PHARMS INC	Modulators of ATP-binding cassette transporters	Apr, 2027 (2 years from now)
US8598181	VERTEX PHARMS INC	Modulators of ATP-binding cassette transporters	May, 2027 (3 years from now)
US8324242	VERTEX PHARMS INC	Modulators of ATP-binding cassette transporters	Aug, 2027 (3 years from now)
US8415387	VERTEX PHARMS INC	Modulators of ATP-binding cassette transporters	Nov, 2027 (3 years from now)
US10646481	VERTEX PHARMS INC	Pharmaceutical composition and administrations thereof	Aug, 2029 (5 years from now)
US11564916	VERTEX PHARMS INC	Pharmaceutical composition and administrations thereof	Aug, 2029 (5 years from now)
US11578062	VERTEX PHARMS INC	Solid forms of (R)-1(2,2-difluorobenzo[d][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxamide	Mar, 2031 (6 years from now)
US10081621	VERTEX PHARMS INC	Solid forms of (R)-1(2,2-difluorobenzo[D][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxamide	Mar, 2031 (6 years from now)
US11147770	VERTEX PHARMS INC	Pharmaceutical composition and administrations thereof	Feb, 2033 (8 years from now)
US11752106	VERTEX PHARMS INC	Pharmaceutical composition and administrations thereof	Feb, 2033 (8 years from now)
US8883206	VERTEX PHARMS INC	Pharmaceutical composition and administrations thereof	Feb, 2033 (8 years from now)
US10272046	VERTEX PHARMS INC	Pharmaceutical composition and administrations thereof	Feb, 2033 (8 years from now)
US9012496	VERTEX PHARMS INC	Pharmaceutical compositions of (R)-1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl)-N-(1-(2,3-dihydroxypropyl)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-yl)-1H-indol-5-yl)cyclopropanecarboxamide and administration thereof	Jul, 2033 (9 years from now)
US11179367	VERTEX PHARMS INC	Pharmaceutical compositions for treating cystic fibrosis	Dec, 2037 (13 years from now)
US11517564	VERTEX PHARMS INC	Methods of treatment for cystic fibrosis	Dec, 2037 (13 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-433)	Apr 26, 2030
New Chemical Entity Exclusivity(NCE)	Oct 21, 2024
New Product(NP)	Apr 26, 2026

Drugs and Companies using ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR ingredient

NCE-1 date: 22 October, 2023

Market Authorisation Date: 26 April, 2023

Treatment: Treatment of a moderate to mild clinical phenotype of cf in patients aged 6 years and older who have at least one f508del mutation in the cftr gene or a mutation in the cftr gene that is responsive ba...

Dosage: GRANULES;ORAL; TABLET;ORAL

TRIKAFTA (COPACKAGED) family patents

35. Turalio patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8722702	DAIICHI SANKYO INC	Compounds modulating c-fms and/or c-kit activity and uses therefor	Nov, 2027 (3 years from now)
US9169250	DAIICHI SANKYO INC	Compounds modulating c-fms and/or c-kit activity and uses therefor	Nov, 2027 (3 years from now)
US8404700	DAIICHI SANKYO INC	Compounds modulating c-fms and/or c-kit activity and uses therefor	Nov, 2027 (3 years from now)
US7893075	DAIICHI SANKYO INC	Compounds modulating c-fms and/or c-kit activity and uses therefor	May, 2033 (9 years from now)
US9802932	DAIICHI SANKYO INC	Solid forms of a compound modulating kinases	May, 2036 (12 years from now)
US10730876	DAIICHI SANKYO INC	Synthesis of a compound that modulates kinases	May, 2036 (12 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8461169	DAIICHI SANKYO INC	Compounds modulating c-fms and/or c-kit activity	Apr, 2028 (3 years from now)
US9358235	DAIICHI SANKYO INC	Kinase modulation, and indications therefor	Jun, 2033 (9 years from now)
US10189833	DAIICHI SANKYO INC	Solid forms of a compound modulating kinases	May, 2036 (12 years from now)
US10961240	DAIICHI SANKYO INC	Formulations of a compound modulating kinases	Jul, 2038 (14 years from now)
US10941142	DAIICHI SANKYO INC	Formulations of a compound modulating kinases	Jul, 2038 (14 years from now)
US10435404	DAIICHI SANKYO INC	Formulations of a compound modulating kinases	Jul, 2038 (14 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-250)	Aug 02, 2026
New Chemical Entity Exclusivity(NCE)	Aug 02, 2024
ODE(ODE)	Aug 02, 2026

Drugs and Companies using PEXIDARTINIB HYDROCHLORIDE ingredient

NCE-1 date: 03 August, 2023

Market Authorisation Date: 14 October, 2022

Treatment: Treatment of adult patients with symptomatic tenosynovial giant cell tumor (tgct) associated with severe morbidity or functional limitations and not amenable to improvement with surgery

Dosage: CAPSULE;ORAL

TURALIO family patents

36. Ubrelvy patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US9499545	ABBVIE	Piperidinone carboxamide azaindane CGRP receptor antagonists	Nov, 2031 (7 years from now)
US8754096	ABBVIE	Piperidinone carboxamide azaindane CGRP receptor antagonists	Jul, 2032 (8 years from now)
US8912210	ABBVIE	Piperidinone carboxamide azaindane CGRP receptor antagonists	Dec, 2033 (9 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9833448	ABBVIE	Piperidinone carboxamide azaindane CGRP receptor antagonists	Nov, 2031 (7 years from now)
US10117836	ABBVIE	Tablet formulation for CGRP active compounds	Jan, 2035 (10 years from now)
US11717515	ABBVIE	Treatment of migraine	Dec, 2041 (17 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Dec 23, 2024

Drugs and Companies using UBROGEPANT ingredient

NCE-1 date: 24 December, 2023

Market Authorisation Date: 23 December, 2019

Treatment: Acute treatment of migraine with or without aura in adults; Acute treatment of migraine with or without aura in a patient with severe hepatic impairment; Acute treatment of migraine with headache, wit...

Dosage: TABLET;ORAL

UBRELVY family patents

37. Vijoice patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8476268	NOVARTIS	Pyrrolidine-1,2-dicarboxamide derivatives	Sep, 2029 (5 years from now)
US8227462	NOVARTIS	Pyrrolidine-1,2-dicarboxamide derivatives	Apr, 2033 (9 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	May 24, 2024
Orphan Drug Exclusivity(ODE-396)	Apr 05, 2029

Drugs and Companies using ALPELISIB ingredient

NCE-1 date: 25 May, 2023

Market Authorisation Date: 05 April, 2022

Treatment: NA

Dosage: TABLET;ORAL

VIJOICE family patents

38. Vyleesi (autoinjector) patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US6579968	PALATIN TECHNOLOGIES	Compositions and methods for treatment of sexual dysfunction	Jun, 2021 (2 years ago)
US6794489	PALATIN TECHNOLOGIES	Compositions and methods for treatment of sexual dysfunction	Jun, 2025 (1 year, 2 months from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10286034	PALATIN TECHNOLOGIES	Uses of bremelanotide in therapy for female sexual dysfunction	Nov, 2033 (9 years from now)
US9352013	PALATIN TECHNOLOGIES	Uses of bremelanotide in therapy for female sexual dysfunction	Nov, 2033 (9 years from now)
US9700592	PALATIN TECHNOLOGIES	Uses of bremelanotide in therapy for female sexual dysfunction	Nov, 2033 (9 years from now)
US11590209	PALATIN TECHNOLOGIES	Use of bremelanotide in patients with controlled hypertension	Apr, 2041 (17 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jun 21, 2024

Drugs and Companies using BREMELANOTIDE ACETATE ingredient

NCE-1 date: 22 June, 2023

Market Authorisation Date: 21 June, 2019

Treatment: Treatment of hypoactive sexual desire disorder (hsdd); Treating acquired, generalized hypoactive sexual desire disorder (hsdd) in a premenopausal female patient with controlled hypertension by injecti...

Dosage: SOLUTION;SUBCUTANEOUS

VYLEESI (AUTOINJECTOR) family patents

39. Vyndamax patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7214695	FOLDRX PHARMS	Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding	Dec, 2024 (7 months from now)
US9770441	FOLDRX PHARMS	Crystalline solid forms of 6-carboxy-2-(3,5-dichlorophenyl)-benzoxazole	Aug, 2035 (11 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7214696	FOLDRX PHARMS	Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding	Dec, 2024 (7 months from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	May 03, 2024
Orphan Drug Exclusivity(ODE-237)	May 03, 2026

Drugs and Companies using TAFAMIDIS ingredient

NCE-1 date: 04 May, 2023

Market Authorisation Date: 03 May, 2019

Treatment: Treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (attr-cm)

Dosage: CAPSULE;ORAL

VYNDAMAX family patents

40. Vyndaqel patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8168663	FOLDRX PHARMS	Pharmaceutically acceptable salt of 6-carboxy-2-(3,5 dichlorophenyl)-benzoxazole, and a pharmaceutical composition comprising the salt thereof	Dec, 2023 (4 months ago)
US7214695	FOLDRX PHARMS	Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding	Dec, 2024 (7 months from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8653119	FOLDRX PHARMS	Methods for treating transthyretin amyloid diseases	Dec, 2023 (4 months ago)
US7214696	FOLDRX PHARMS	Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding	Dec, 2024 (7 months from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	May 03, 2024
Orphan Drug Exclusivity(ODE-237)	May 03, 2026

Drugs and Companies using TAFAMIDIS MEGLUMINE ingredient

NCE-1 date: 04 May, 2023

Market Authorisation Date: 03 May, 2019

Treatment: Treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (attr-cm)

Dosage: CAPSULE;ORAL

VYNDAQEL family patents

41. Vyondys 53 patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US9416361	SAREPTA THERAPS INC	Splice-region antisense composition and method	May, 2021 (2 years ago)
US10968450	SAREPTA THERAPS INC	Antisense oligonucleotides for inducing exon skipping and methods of use thereof	Jun, 2025 (1 year, 2 months from now)
US10227590	SAREPTA THERAPS INC	Antisense oligonucleotides for inducing exon skipping and methods of use thereof	Jun, 2025 (1 year, 2 months from now)
US9024007	SAREPTA THERAPS INC	Antisense oligonucleotides for inducing exon skipping and methods of use thereof	Jun, 2025 (1 year, 2 months from now)
US9994851	SAREPTA THERAPS INC	Antisense oligonucleotides for inducing exon skipping and methods of use thereof	Jun, 2025 (1 year, 2 months from now)
US10421966	SAREPTA THERAPS INC	Antisense oligonucleotides for inducing exon skipping and methods of use thereof	Jun, 2025 (1 year, 2 months from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10533174	SAREPTA THERAPS INC	Splice-region antisense composition and method	May, 2021 (2 years ago)
US10995337	SAREPTA THERAPS INC	Antisense oligonucleotides for inducing exon skipping and methods of use thereof	Jun, 2025 (1 year, 2 months from now)
USRE47691	SAREPTA THERAPS INC	Antisense oligonucleotides for inducing exon skipping and methods of use thereof	Jun, 2025 (1 year, 2 months from now)
US10266827	SAREPTA THERAPS INC	Antisense oligonucleotides for inducing exon skipping and methods of use thereof	Jun, 2025 (1 year, 2 months from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-280)	Dec 12, 2026
New Chemical Entity Exclusivity(NCE)	Dec 12, 2024

Drugs and Companies using GOLODIRSEN ingredient

NCE-1 date: 13 December, 2023

Market Authorisation Date: 12 December, 2019

Treatment: Treatment of duchenne muscular dystrophy (dmd) in patients having a confirmed mutation of the dmd gene that is amenable to exon 53 skipping

Dosage: SOLUTION;INTRAVENOUS

VYONDYS 53 family patents

42. Wakix patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7169928	HARMONY	Non-imidazole alkylamines as histamine H3-receptor ligands and their therapeutic applications	Feb, 2020 (4 years ago)
US8207197	HARMONY	Monohydrochloride salt of 1-[3-[3-(4-chlorophenyl) propoxy] propyl] -piperidine	Mar, 2030 (5 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7910605	HARMONY	Non-imidazole alkylamines as histamine H3- receptor ligands and their therapeutic applications	Sep, 2022 (1 year, 7 months ago)
US8354430	HARMONY	Monohydrochloride salt of 1-[3-[3-(4-chlorophenyl) propoxy]propyl]-piperidine	Feb, 2026 (1 year, 9 months from now)
US8486947	HARMONY	Treatment of Parkinson's disease, obstructive sleep apnea, dementia with Lewy bodies, vascular dementia with non-imidazole alkylamines histamine H3-receptor ligands	Sep, 2029 (5 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Aug 14, 2024
Orphan Drug Exclusivity(ODE-255)	Aug 14, 2026
Orphan Drug Exclusivity(ODE-331)	Oct 13, 2027
New Indication(I-846)	Oct 13, 2023

Drugs and Companies using PITOLISANT HYDROCHLORIDE ingredient

NCE-1 date: 15 August, 2023

Market Authorisation Date: 14 August, 2019

Treatment: Method of treating cataplexy in patients with narcolepsy

Dosage: TABLET;ORAL

WAKIX family patents

43. Xphozah patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8969377	ARDELYX INC	Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders	Dec, 2029 (5 years from now)
US8541448	ARDELYX INC	Compounds and methods for inhibiting NHE-mediated antiport in the treatment of disorders associated with fluid retention or salt overload and gastrointestinal tract disorders	Aug, 2033 (9 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10272079	ARDELYX INC	NHE3-binding compounds and methods for inhibiting phosphate transport	Apr, 2034 (9 years from now)
US10940146	ARDELYX INC	NHE3-binding compounds and methods for inhibiting phosphate transport	Apr, 2034 (9 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Oct 17, 2026
New Chemical Entity Exclusivity(NCE)	Sep 12, 2024

Drugs and Companies using TENAPANOR HYDROCHLORIDE ingredient

NCE-1 date: 13 September, 2023

Market Authorisation Date: 17 October, 2023

Treatment: Treatment of hyperphosphatemia; Reduction of serum phosphorus in adults

Dosage: TABLET;ORAL

XPHOZAH family patents

44. Xpovio patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US9714226	KARYOPHARM THERAPS	Hydrazide containing nuclear transport modulators and uses thereof	Jul, 2032 (8 years from now)
US8999996	KARYOPHARM THERAPS	Hydrazide containing nuclear transport modulators and uses thereof	Jul, 2033 (9 years from now)
US10519139	KARYOPHARM THERAPS	Polymorphs of Selinexor	Aug, 2035 (11 years from now)
US11807629	KARYOPHARM THERAPS	Polymorphs of Selinexor	Aug, 2035 (11 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10544108	KARYOPHARM THERAPS	Hydrazide containing nuclear transport modulators and uses thereof	Jul, 2032 (8 years from now)
US9079865	KARYOPHARM THERAPS	Hydrazide containing nuclear transport modulators and uses thereof	Jul, 2032 (8 years from now)
US11787771	KARYOPHARM THERAPS	Hydrazide containing nuclear transport modulators and uses thereof	Jul, 2032 (8 years from now)
US11034660	KARYOPHARM THERAPS	Hydrazide containing nuclear transport modulators and uses thereof	Jul, 2032 (8 years from now)
US11746102	KARYOPHARM THERAPS	Polymorphs of selinexor	Aug, 2035 (11 years from now)
US11753401	KARYOPHARM THERAPS	Polymorphs of Selinexor	Aug, 2035 (11 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
ODE(ODE)	Jul 03, 2026
Orphan Drug Exclusivity(ODE-257)	Jul 03, 2026
New Chemical Entity Exclusivity(NCE)	Jul 03, 2024
Orphan Drug Exclusivity(ODE-310)	Jun 22, 2027
Orphan Drug Exclusivity(ODE-346)	Dec 18, 2027
New Indication(I-837)	Jun 22, 2023

Drugs and Companies using SELINEXOR ingredient

NCE-1 date: 04 July, 2023

Market Authorisation Date: 03 July, 2019

Treatment: Xpovio is indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; Xpovio is indicated for the...

Dosage: TABLET;ORAL

XPOVIO family patents

45. Zerbaxa patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7129232	CUBIST PHARMS LLC	Cephem compounds	May, 2028 (4 years from now)
US8685957	CUBIST PHARMS LLC	Tazobactam arginine compositions	Sep, 2032 (8 years from now)
US8476425	CUBIST PHARMS LLC	Tazobactam arginine compositions	Sep, 2032 (8 years from now)
US8906898	CUBIST PHARMS LLC	Solid forms of ceftolozane	May, 2034 (10 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9724353	CUBIST PHARMS LLC	Methods for treating intrapulmonary infections	Sep, 2032 (8 years from now)
US10028963	CUBIST PHARMS LLC	Methods for treating intrapulmonary infections	Sep, 2032 (8 years from now)
US11278622	CUBIST PHARMS LLC	Ceftolozane antibiotic compositions	Mar, 2034 (9 years from now)
US9320740	CUBIST PHARMS LLC	Ceftolozane-tazobactam pharmaceutical compositions	Mar, 2034 (9 years from now)
US8968753	CUBIST PHARMS LLC	Ceftolozane-tazobactam pharmaceutical compositions	Mar, 2034 (9 years from now)
US10420841	CUBIST PHARMS LLC	Ceftolozane antibiotic compositions	Mar, 2034 (9 years from now)
US9872906	CUBIST PHARMS LLC	Ceftolozane antibiotic compositions	Mar, 2034 (9 years from now)
US10933053	CUBIST PHARMS LLC	Treating infections with ceftolozane/tazobactam in subjects having impaired renal function	Sep, 2034 (10 years from now)
US10376496	CUBIST PHARMS LLC	Treating infections with ceftolozane/tazobactam in subjects having impaired renal function	Sep, 2034 (10 years from now)
US10125149	CUBIST PHARMS LLC	Synthesis of cephalosporin compounds	Aug, 2035 (11 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Dec 19, 2019
New Patient Population(NPP)	Apr 21, 2025
Generating Antibiotic Incentives Now(GAIN)	Dec 19, 2024

Drugs and Companies using CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM ingredient

NCE-1 date: 20 December, 2023

Market Authorisation Date: 19 December, 2014

Treatment: Treatment of ventilator-associated bacterial pneumonia; Treatment of hospital-acquired bacterial pneumonia; Treatment of ventilator-associated bacterial pneumonia (vabp); Complicated intra-abdominal i...

Dosage: POWDER;INTRAVENOUS

ZERBAXA family patents

46. Zulresso patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10117951	SAGE THERAP	Sulfoalkyl ether cyclodextrin compositions	Mar, 2029 (4 years from now)
US7635773	SAGE THERAP	Sulfoalkyl ether cyclodextrin compositions	Mar, 2029 (4 years from now)
US8410077	SAGE THERAP	Sulfoalkyl ether cyclodextrin compositions	Mar, 2029 (4 years from now)
US9750822	SAGE THERAP	Sulfoalkyl ether cyclodextrin compositions	Mar, 2029 (4 years from now)
US9200088	SAGE THERAP	Sulfoalkyl ether cyclodextrin compositions	Mar, 2029 (4 years from now)
US10322139	SAGE THERAP	Neuroactive steroid formulations and methods of treating CNS disorders	Jan, 2033 (8 years from now)
US10251894	SAGE THERAP	Anticonvulsant activity of steroids	Nov, 2033 (9 years from now)
US10940156	SAGE THERAP	Neuroactive steroids, compositions, and uses thereof	Mar, 2037 (12 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jun 17, 2024
New Patient Population(NPP)	Jun 16, 2025

Drugs and Companies using BREXANOLONE ingredient

NCE-1 date: 18 June, 2023

Market Authorisation Date: 17 June, 2019

Treatment: Method of treating postpartum depression

Dosage: SOLUTION;INTRAVENOUS

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US7326708	June, 2020	Final Written Decision	Merck Sharp & Dohme Corp. et al.	Sun Pharmaceutical Industries Ltd. et al.
US7326708	June, 2020	Final Written Decision	Merck Sharp & Dohme Corp. et al.	Dr. Reddy's Laboratories, Inc. et al.
US7326708	June, 2020	Terminated-Settled	Merck Sharp & Dohme Corp.	Teva Pharmaceuticals USA, Inc.
US7326708	October, 2019	Final Written Decision	Merck Sharp & Dohme Corp. et al.	Mylan Pharmaceuticals, Inc.

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US7326708	June, 2020	Final Written Decision	Merck Sharp & Dohme Corp. et al.	Sun Pharmaceutical Industries Ltd. et al.
US7326708	June, 2020	Final Written Decision	Merck Sharp & Dohme Corp. et al.	Dr. Reddy's Laboratories, Inc. et al.
US7326708	June, 2020	Terminated-Settled	Merck Sharp & Dohme Corp.	Teva Pharmaceuticals USA, Inc.
US7326708	October, 2019	Final Written Decision	Merck Sharp & Dohme Corp. et al.	Mylan Pharmaceuticals, Inc.

Strength	Submission Date	ANDA(s) Filed	Last patent expiry	180 day status
25 mg, 50 mg and 100 mg	18 Oct, 2010	6	24 Nov, 2026
100 mg/10 mg and 100 mg/40 mg	19 Jun, 2012	1	11 Apr, 2026	Extinguished
100 mg/20 mg	25 Jun, 2012	1	11 Apr, 2026	Extinguished
50 mg/10 mg 50 mg/20 mg 50 mg/40 mg	06 Nov, 2012	1	11 Apr, 2026	Extinguished

Application	Filing Date	Opposition Party	Legal Status

EP05077584A	2011-03-15	APOTEX INC.	Revoked
EP04755691A	2008-06-11	Teva Pharmaceutical Industries Ltd.	Patent maintained as amended

Strength	Dosage	Availability
500MG;EQ 50MG BASE	TABLET;ORAL	Prescription
1GM;EQ 50MG BASE	TABLET;ORAL	Prescription

Strength	Dosage	Availability
EQ 25MG BASE	TABLET;ORAL	Prescription
EQ 50MG BASE	TABLET;ORAL	Prescription
EQ 100MG BASE	TABLET;ORAL	Prescription

Application	Filing Date	Opposition Party	Legal Status

EP09810708A	2017-01-13	Prüfer & Partner mbB	Granted and Under Opposition

Strength	Dosage	Availability
EQ 2MG BASE	TABLET;ORAL	Prescription
EQ 0.25MG BASE	TABLET;ORAL	Prescription
EQ 1MG BASE	TABLET;ORAL	Prescription

Application	Filing Date	Opposition Party	Legal Status

EP09817723A	2021-09-30	Teva Pharmaceutical Industries Ltd	Granted and Under Opposition
EP09817723A	2021-09-30	Brand Murray Fuller LLP	Granted and Under Opposition
EP09817723A	2021-09-29	Bülle Dr., Jan	Granted and Under Opposition
EP09817723A	2021-09-29	Hamm&Wittkopp Patentanwälte PartmbB	Granted and Under Opposition
EP09817723A	2021-09-29	Sanovel Ilaç Sanayi Ve Ticaret Anonim Sirketi	Granted and Under Opposition
EP09817723A	2021-09-23	Sandoz AG	Granted and Under Opposition
EP08843784A	2013-07-17	Huenges Martin/, Glas Holger	Revoked

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
25 mg	28 Jun, 2016	6	27 Dec, 2019	04 Nov, 2023	Extinguished Eligible
50 mg	28 Jun, 2016	6	28 Sep, 2022	04 Nov, 2023	Deferred

Strength	Dosage	Availability
25MG	TABLET, EXTENDED RELEASE;ORAL	Prescription
50MG	TABLET, EXTENDED RELEASE;ORAL	Prescription

Application	Filing Date	Opposition Party	Legal Status

EP16704029A	2023-02-17	Hamm&Wittkopp Patentanwälte PartmbB	Granted and Under Opposition

Application	Filing Date	Opposition Party	Legal Status

EP15746995A	2021-10-13	Bülle Dr., Jan	Granted and Under Opposition

Strength	Dosage	Availability
150MG	TABLET;ORAL	Prescription
200MG	TABLET;ORAL	Prescription
50MG	TABLET;ORAL	Prescription

Application	Filing Date	Opposition Party	Legal Status

EP03743368A	2013-04-03	Sanovel IIaç San. ve Tic. A.S.	Patent maintained as amended
EP03743368A	2013-03-27	Stötter, Gerd	Patent maintained as amended
EP07115663A	2012-10-10	Sanovel IIaç San. ve Tic. A.S.	Revoked
EP07115663A	2012-10-05	Stötter, Gerd	Revoked
EP09153155A	2012-07-13	PONS PATENTES Y MARCAS INTERNACIONAL, S.L.	Revoked
EP09153155A	2012-07-12	Sanovel Ilac Sanayii ve Ticaret A.S.	Revoked
EP09153155A	2012-07-06	Stötter, Gerd	Revoked
EP04764411A	2010-01-29	APOTEX INC.	Opposition rejected

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
eq. to 75 mg base and 150 mg base	20 Oct, 2014	17	06 May, 2020	31 Aug, 2027	Eligible
eq. to 110 mg base	15 Dec, 2015	2		20 Jan, 2031

Strength	Dosage	Availability
EQ 110MG BASE	CAPSULE;ORAL	Prescription
EQ 150MG BASE	CAPSULE;ORAL	Prescription
EQ 75MG BASE	CAPSULE;ORAL	Prescription

Application	Filing Date	Opposition Party	Legal Status

EP10835061A	2018-02-16	Generics (U.K.) Limited	Opposition rejected

Strength	Dosage	Availability
30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription
15MG	TABLET, EXTENDED RELEASE;ORAL	Prescription
45MG	TABLET, EXTENDED RELEASE;ORAL	Prescription

Strength	Dosage	Availability
200MG/VIAL	POWDER;INTRAVENOUS	Prescription
200MG	TABLET;ORAL	Prescription

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US6858650	August, 2016	FWD Entered	UCB Pharma GmbH	Alembic Pharmaceuticals Limited
US6858650	August, 2016	FWD Entered	UCB Pharma GmbH	Amerigen Pharmaceuticals Limited
US6858650	August, 2016	FWD Entered	UCB Pharma GmbH	Torrent Pharmaceuticals Limited
US6858650	January, 2016	FWD Entered	UCB Pharma GmbH	Mylan Pharmaceuticals Inc

Strength	Dosage	Availability
EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML)	SOLUTION;INTRAVENOUS	Prescription
EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (1ML)	SOLUTION;INTRAVENOUS	Prescription

Application	Filing Date	Opposition Party	Legal Status

EP17204189A	2021-09-09	STADA Arzneimittel AG	Granted and Under Opposition
EP17204189A	2021-09-07	Lederer & Keller Patentanwälte Partnerschaft mbB	Granted and Under Opposition
EP17204189A	2021-09-06	Teva Pharmaceutical Industries Ltd	Granted and Under Opposition
EP15849396A	2021-05-05	Generics [UK] Limited	Granted and Under Opposition
EP10708442A	2019-10-07	Teva Pharmaceutical Industries Ltd	Granted and Under Opposition
EP06848237A	2017-11-03	Georg Kalhammer/Stephan Teipel	Opposition rejected

Pharsight

Drugs facing NCE-1 in 2023

1. Accrufer patents expiration

ACCRUFER family patents

2. Aklief patents expiration

AKLIEF family patents

3. Aubagio patents expiration

AUBAGIO family patents

4. Austedo patents expiration

AUSTEDO family patents

5. Balversa patents expiration

BALVERSA family patents

6. Brukinsa patents expiration

BRUKINSA family patents

7. Caplyta patents expiration

CAPLYTA family patents

8. Dalvance patents expiration

DALVANCE family patents

9. Exem Foam Kit patents expiration

EXEM FOAM KIT family patents

10. Givlaari patents expiration

GIVLAARI family patents

11. Harvoni patents expiration

HARVONI family patents

12. Ibsrela patents expiration

IBSRELA family patents

13. Inrebic patents expiration

INREBIC family patents

14. Janumet patents expiration

JANUMET family patents

15. Januvia patents expiration

JANUVIA family patents

16. Kimyrsa patents expiration

KIMYRSA family patents

17. Mayzent patents expiration

MAYZENT family patents

18. Multrys patents expiration

MULTRYS family patents

19. Myrbetriq patents expiration

MYRBETRIQ family patents

20. Nourianz patents expiration

NOURIANZ family patents

21. Nubeqa patents expiration

NUBEQA family patents

22. Orbactiv patents expiration

ORBACTIV family patents

23. Oxbryta patents expiration

OXBRYTA family patents

24. Piqray patents expiration

PIQRAY family patents

25. Pradaxa patents expiration

PRADAXA family patents

26. Rinvoq patents expiration

RINVOQ family patents

27. Rozlytrek patents expiration

ROZLYTREK family patents

28. Scenesse patents expiration

SCENESSE family patents

29. Sivextro patents expiration

SIVEXTRO family patents

30. Sovaldi patents expiration

SOVALDI family patents

31. Sunosi patents expiration

SUNOSI family patents

32. Toviaz patents expiration

TOVIAZ family patents

33. Tralement patents expiration

TRALEMENT family patents

34. Trikafta (copackaged) patents expiration

TRIKAFTA (COPACKAGED) family patents

35. Turalio patents expiration

TURALIO family patents

36. Ubrelvy patents expiration

UBRELVY family patents

37. Vijoice patents expiration

VIJOICE family patents

38. Vyleesi (autoinjector) patents expiration

VYLEESI (AUTOINJECTOR) family patents

39. Vyndamax patents expiration

VYNDAMAX family patents

Strength	Dosage	Availability
80MG, 60MG, 40MG;59.5MG	GRANULES;ORAL	Prescription
100MG,75MG,50MG; 150MG	TABLET;ORAL	Prescription
100MG, 75MG, 50MG;75MG	GRANULES;ORAL	Prescription
50MG,37.5MG,25MG; 75MG	TABLET;ORAL	Prescription

Strength	Dosage	Availability
EQ 200MG BASE	CAPSULE;ORAL	Discontinued
EQ 125MG BASE	CAPSULE;ORAL	Prescription

Strength	Dosage	Availability
125MG	TABLET;ORAL	Prescription
200MG	TABLET;ORAL	Prescription
50MG	TABLET;ORAL	Prescription

Application	Filing Date	Opposition Party	Legal Status

EP13851014A	2019-06-18	Teva Pharmaceutical Industries Ltd.	Granted and Under Opposition

Application	Filing Date	Opposition Party	Legal Status

EP06744466A	2014-02-27	Sölch, Günter	Patent maintained as amended

Strength	Dosage	Availability
EQ 17.8MG BASE	TABLET;ORAL	Prescription
EQ 4.45MG BASE	TABLET;ORAL	Prescription

Strength	Dosage	Availability
EQ 30MG BASE	TABLET;ORAL	Prescription
EQ 20MG BASE	TABLET;ORAL	Prescription
EQ 10MG BASE	TABLET;ORAL	Prescription

Application	Filing Date	Opposition Party	Legal Status

EP14842042A	2020-12-21	Lederer & Keller Patentanwälte Partnerschaft mbB	Opposition rejected

Application	Filing Date	Opposition Party	Legal Status

EP13740743A	2020-07-08	Dr. Schön, Neymeyr & Partner Patentanwälte mbB	Granted and Under Opposition