Pharsight

1. List of Akynzeo drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US9908907	HELSINN HLTHCARE	Substituted piperaziniums for the treatment of emesis	May, 2032 (9 years from now)
US11312698	HELSINN HLTHCARE	Fosnetupitant chloride hydrochloride having improved stability	May, 2032 (9 years from now)
US10717721	HELSINN HLTHCARE	Substituted piperaziniums for the treatment of emesis	May, 2032 (9 years from now)
US8426450	HELSINN HLTHCARE	Substituted 4-phenyl pyridines having anti-emetic effect	May, 2032 (9 years from now)
US9403772	HELSINN HLTHCARE	4-(5-(2-(3,5-bis(trifluoromethyl)phenyl)-N,2-dimethylpropanamido)-4-(o-tolyl)pyridin-2-yl)-1-methyl-1-((phosphonooxy)methyl)piperazin-1-ium as a neurokinin receptor modulator	May, 2032 (9 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9186357	HELSINN HLTHCARE	Compositions and methods for treating centrally mediated nausea and vomiting	Nov, 2030 (7 years from now)
US10828297	HELSINN HLTHCARE	Compositions and methods for treating centrally mediated nausea and vomiting	Dec, 2030 (7 years from now)
US10208073	HELSINN HLTHCARE	Solution comprising the chloride hydrochloride salt of 4-(5-(2-(3,5-bis(trifluoromethyl)phenyl)-N,2-dimethylpropanamido)-4-(o-tolyl)pyridin-2-yl)-1-methyl-1-((phosphonooxy)methyl)piperazin-1-IUM-(fosnetupitant) and palonosetron hydrochloride in combination with dexamethasone as a neurokinin receptor modulator	May, 2032 (9 years from now)
US8895586	HELSINN HLTHCARE	Methods of treating emesis	May, 2032 (9 years from now)
US10624911	HELSINN HLTHCARE	Physiologically balanced injectable formulations of fosnetupitant	Jun, 2037 (14 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Apr 19, 2023

Drugs and Companies using FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE ingredient

NCE-1 date: April, 2022

Market Authorisation Date: 19 April, 2018

Treatment: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy

Dosage: POWDER;INTRAVENOUS; SOLUTION;INTRAVENOUS

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
235 mg/0.25 mg per 20 mL	19 Apr, 2022	1		02 Jun, 2037

Strength	Dosage	Availability
EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL	POWDER;INTRAVENOUS	Prescription
EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML)	SOLUTION;INTRAVENOUS	Prescription

2. List of Annovera drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10765628	THERAPEUTICSMD INC	Method of providing birth control	Feb, 2039 (16 years from now)
US10780047	THERAPEUTICSMD INC	Method of providing birth control	Feb, 2039 (16 years from now)
US10632066	THERAPEUTICSMD INC	Method of providing birth control	Feb, 2039 (16 years from now)
US10925882	THERAPEUTICSMD INC	System for providing birth control	Jun, 2039 (16 years from now)
US10918649	THERAPEUTICSMD INC	System for providing birth control	Jun, 2039 (16 years from now)
US11529308	THERAPEUTICSMD INC	System for providing birth control	Jun, 2039 (16 years from now)
US10940157	THERAPEUTICSMD INC	System for providing birth control	Jun, 2039 (16 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Aug 10, 2023

Drugs and Companies using ETHINYL ESTRADIOL; SEGESTERONE ACETATE ingredient

NCE-1 date: August, 2022

Market Authorisation Date: 10 August, 2018

Treatment: Method of preventing pregnancy by inserting a vaginal system containing 103 mg of segesterone acetate and 17.4 mg ethinyl estradiol into a vagina for up to thirteen 21/7-day (in/out) cycles; Method of contraception by inserting a vaginal system for up to 13 21/7-day (in/out) cycles, wherein efficacy requires the system cannot be out of the vagina for more than 2 cumulative hours in any such cycle without using alternative contraception

Dosage: RING;VAGINAL

Strength	Dosage	Availability
0.013MG/24HR;0.15MG/24HR	RING;VAGINAL	Prescription

3. List of Arakoda drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10888558	60 DEGREES PHARMS	Regimens of tafenoquine for prevention of malaria in malaria-naive subjects	Dec, 2035 (12 years from now)
US10342791	60 DEGREES PHARMS	Regimens of tafenoquine for prevention of malaria in malaria-naive subjects	Dec, 2035 (12 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Jul 20, 2023

Drugs and Companies using TAFENOQUINE SUCCINATE ingredient

NCE-1 date: July, 2022

Market Authorisation Date: 08 August, 2018

Treatment: For the oral prevention/prophylaxis of malaria in adults, comprising a three-phase dosing regimen consisting of a loading/initial dose, a maintenance/exposure dose, and a terminal/post-exposure dose

Dosage: TABLET;ORAL

Strength	Dosage	Availability
EQ 100MG BASE	TABLET;ORAL	Prescription

4. List of Biktarvy drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US7390791	GILEAD SCIENCES INC	Prodrugs of phosphonate nucleotide analogues	Apr, 2025 (2 years from now)
US8754065	GILEAD SCIENCES INC	Tenofovir alafenamide hemifumarate	Aug, 2032 (9 years from now)
US9296769	GILEAD SCIENCES INC	Tenofovir alafenamide hemifumarate	Aug, 2032 (9 years from now)
US9216996	GILEAD SCIENCES INC	Substituted 2,3,4,5,7,9,13,13a-octahydropyrido[1′,2′:4,5]pyrazino[2,1-b][1,3]oxazepines and methods for treating viral infections	Dec, 2033 (10 years from now)
US9732092	GILEAD SCIENCES INC	Substituted 2,3,4,5,7,9,13,13a-octahydropyrido[1′,2′:4,5]pyrazino[2,1-b][1,3]OXAZEPINES and methods for treating viral infections	Dec, 2033 (10 years from now)
US9708342	GILEAD SCIENCES INC	Sodium (2R,5S,13aR)-7,9-dioxo-10-((2,4,6-trifluorobenzyl)carbamoyl)-2,3,4,5,7,9,13,13a-octahydro-2,5-methanopyrido[1′,2′:4,5]pyrazino[2, 1-b][1, 3]oxazepin-8-olate	Jun, 2035 (12 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7803788	GILEAD SCIENCES INC	Prodrugs of phosphonate nucoleotide analogues	Feb, 2022 (a year ago)
US7390791 (Pediatric)	GILEAD SCIENCES INC	Prodrugs of phosphonate nucleotide analogues	Oct, 2025 (2 years from now)
US9296769 (Pediatric)	GILEAD SCIENCES INC	Tenofovir alafenamide hemifumarate	Feb, 2033 (10 years from now)
US8754065 (Pediatric)	GILEAD SCIENCES INC	Tenofovir alafenamide hemifumarate	Feb, 2033 (10 years from now)
US10385067	GILEAD SCIENCES INC	Sodium (2R,5S,13aR)-7,9-dioxo-10-((2,4,6-trifluorobenzyl)carbamoyl)-2,3,4,5,7,9,13,13a-octahydro-2,5-methanopyrido[1′,2′:4,5]pyrazino[2,1-b][1,3]oxazepin-8-olate	Jun, 2035 (12 years from now)
US10548846	GILEAD SCIENCES INC	Therapeutic compositions for treatment of human immunodeficiency virus	Nov, 2036 (13 years from now)

Exclusivity	Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Jun 18, 2026
New Chemical Entity Exclusivity (NCE)	Feb 7, 2023
New Patient Population (NPP)	Jun 18, 2022
M	Feb 24, 2024

Drugs and Companies using BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE ingredient

NCE-1 date: February, 2022

Market Authorisation Date: 07 February, 2018

Treatment: Treatment of hiv infection

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
50 mg/200 mg/ 25 mg	07 Feb, 2022	3		08 Nov, 2036

Strength	Dosage	Availability
EQ 30MG BASE;120MG;EQ 15MG BASE	TABLET;ORAL	Prescription
EQ 50MG BASE;200MG;EQ 25MG BASE	TABLET;ORAL	Prescription

5. List of Braftovi drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8946250	ARRAY BIOPHARMA INC	3,4-diarylpyrazoles as protein kinase inhibitors	Jul, 2029 (6 years from now)
US8541575	ARRAY BIOPHARMA INC	3,4-diarylpyrazoles as protein kinase inhibitors	Feb, 2030 (7 years from now)
US9593099	ARRAY BIOPHARMA INC	Compounds and compositions as protein kinase inhibitors	Aug, 2030 (7 years from now)
US8501758	ARRAY BIOPHARMA INC	Compounds and compositions as protein kinase inhibitors	Mar, 2031 (8 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10005761	ARRAY BIOPHARMA INC	Compounds and compositions as protein kinase inhibitors	Aug, 2030 (7 years from now)
US9593100	ARRAY BIOPHARMA INC	Compounds and compositions as protein kinase inhibitors	Aug, 2030 (7 years from now)
US9850230	ARRAY BIOPHARMA INC	Compounds and compositions as protein kinase inhibitors	Aug, 2030 (7 years from now)
US9850229	ARRAY BIOPHARMA INC	Compounds and compositions as protein kinase inhibitors	Aug, 2030 (7 years from now)
US9314464	ARRAY BIOPHARMA INC	Compounds and compositions as protein kinase inhibitors	Jul, 2031 (8 years from now)
US9387208	ARRAY BIOPHARMA INC	Pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methylsulfonamido)phenyl)-1-isopropyl-1H-pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl)carbamate	Nov, 2032 (9 years from now)
US9763941	ARRAY BIOPHARMA INC	Method of treating melanoma by administration of pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methylsulfonamido)phenyl)-1-isopropyl-1H-pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl)carbamate	Nov, 2032 (9 years from now)
US10258622	ARRAY BIOPHARMA INC	Method of treating colorectal cancer by administration of pharmaceutical formulations of (S)-methyl (1-((4-(3-(5-chloro-2-fluoro-3-(methylsulfonamido)pheny1)-1-isopropyl-1H-pyrazol-4-yl)pyrimidin-2-yl)amino)propan-2-yl) carbamate	Nov, 2032 (9 years from now)
US9474754	ARRAY BIOPHARMA INC	Pharmaceutical combinations comprising a B-RAF inhibitor, and EGFR inhibitor and optionally a PI3K-α inhibitor	Aug, 2033 (10 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Jun 27, 2023
Orphan Drug Exclusivity (ODE)	Jun 27, 2025
New Indication (I)	Apr 8, 2023

Drugs and Companies using ENCORAFENIB ingredient

NCE-1 date: June, 2022

Market Authorisation Date: 27 June, 2018

Treatment: Treatment of melanoma; Braftovi is a kinase inhibitor indicated in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (crc) with a braf v600e mutation, as detected by an fda-approved test, after prior therapy; Braftovi is a kinase inhibitor indicated in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a braf v600e or v600k mutation, as detected by an fda- approved test; Treatment of melanoma with a braf mutation; Indicated in combination with binimetinib for the treatment of melanoma with a braf mutation; Treatment of melanoma mediated by a b-raf protein kinase

Dosage: CAPSULE;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
75 mg	27 Jun, 2022	3		05 Aug, 2033

Strength	Dosage	Availability
50MG	CAPSULE;ORAL	Discontinued
75MG	CAPSULE;ORAL	Prescription

6. List of Copiktra drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8193182	SECURA	Substituted isoquinolin-1(2H)-ones, and methods of use thereof	Feb, 2030 (7 years from now)
USRE46621	SECURA	Processes for preparing isoquinolinones and solid forms of isoquinolinones	May, 2032 (9 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9216982	SECURA	Certain chemical entities, compositions and methods	Jan, 2029 (5 years from now)
US11312718	SECURA	Formulations of (S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one	Jan, 2032 (8 years from now)
US9840505	SECURA	Solid forms of (S)-3-(1-(9H-purin-6-ylamino)ethyl)-8-chloro-2-phenylisoquinolin-1 (2H)-one and methods of use thereof	Jan, 2032 (8 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Sep 24, 2023
Orphan Drug Exclusivity (ODE)	Sep 24, 2025

Drugs and Companies using DUVELISIB ingredient

NCE-1 date: September, 2022

Market Authorisation Date: 24 September, 2018

Treatment: For the treatment of patients with follicular lymphoma (fl); For the treatment of patients with chronic lymphocytic leukemia (cll) and/or small lymphocytic leukemia (sll)

Dosage: CAPSULE;ORAL

Strength	Dosage	Availability
15MG	CAPSULE;ORAL	Prescription
25MG	CAPSULE;ORAL	Prescription

7. List of Daurismo drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8148401	PFIZER	Benzimidazole derivatives	Jan, 2031 (7 years from now)
US10414748	PFIZER	Crystalline forms of 1-((2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate	Apr, 2036 (13 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8431597	PFIZER	Benzimidazole derivatives	Jun, 2028 (5 years from now)
US11168066	PFIZER	Crystalline forms of 1-((2R,4R)-2-(1H-benzo[d]imidazol-2-yl)-1-methylpiperidin-4-yl)-3-(4-cyanophenyl)urea maleate	Apr, 2036 (13 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Nov 21, 2023
Orphan Drug Exclusivity (ODE)	Nov 21, 2025

Drugs and Companies using GLASDEGIB MALEATE ingredient

NCE-1 date: November, 2022

Market Authorisation Date: 21 November, 2018

Treatment: Use, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (aml) in adult patients who are >= 75 years old or who have comorbidities that preclude use of intensive induction chemotherapy

Dosage: TABLET;ORAL

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

8. List of Delstrigo drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8486975	MSD MERCK CO	Non-nucleoside reverse transcriptase inhibitors	Oct, 2031 (8 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10603282	MSD MERCK CO	Pharmaceutical compositions containing doravirine, tenofovir disoproxil fumarate and lamivudine	Nov, 2036 (13 years from now)
US10842751	MSD MERCK CO	Pharmaceutical compositions containing doravirine, tenofovir disoproxil fumarate and lamivudine	Nov, 2036 (13 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Aug 30, 2023
New Indication (I)	Sep 19, 2022
New Patient Population (NPP)	Jan 27, 2025

Drugs and Companies using DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE ingredient

NCE-1 date: August, 2022

Market Authorisation Date: 30 August, 2018

Treatment: Treatment of hiv-1 infection in adult patients as a replacement therapy in virologically suppressed adults with no history of treatment failure and no known substitutions associated with resistance to the individual components of delstrigo; For the treatment of hiv-1 infection in adult patients with no prior antiretroviral treatment history; Treatment of hiv-1 infection in pediatric patients weighing at least 35kg with no prior antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
100 mg/300 mg/ 300 mg	30 Aug, 2022	1		29 Nov, 2036

Strength	Dosage	Availability
100MG;300MG;300MG	TABLET;ORAL	Prescription

9. List of Doptelet drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US7638536	AKARX INC	2-Acylaminothiazole derivative or salt thereof	May, 2025 (2 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8765764	AKARX INC	2-acylaminothiazole derivative or salt thereof	Jan, 2023 (18 days ago)
US8338429	AKARX INC	2-acylaminothiazole derivative or salt thereof	Jun, 2023 (4 months from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	May 21, 2023
Orphan Drug Exclusivity (ODE)	Jun 26, 2026
New Indication (I)	Jun 26, 2022

Drugs and Companies using AVATROMBOPAG MALEATE ingredient

NCE-1 date: May, 2022

Market Authorisation Date: 21 May, 2018

Treatment: Treatment of thrombocytopenia in an adult patient with chronic liver disease who is scheduled to undergo a procedure using doptelet; Treatment of thrombocytopenia in an adult patient with chronic liver disease who is scheduled to undergo a procedure; Treatment of thrombocytopenia in an adult patient with chronic immune thrombocytopenia who has had an insufficient response to a previous treatment

Dosage: TABLET;ORAL

Strength	Dosage	Availability
EQ 20MG BASE	TABLET;ORAL	Prescription

10. List of Epidiolex drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US10195159	GW RES LTD	Processes and apparatus for extraction of active substances and enriched extracts from natural products	May, 2022 (8 months ago)
US11096905	GW RES LTD	Use of cannabinoids in the treatment of epilepsy	Oct, 2035 (12 years from now)
US11207292	GW RES LTD	Cannabidiol preparations and its uses	Apr, 2039 (16 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11154516	GW RES LTD	Use of cannabinoids in the treatment of epilepsy	Jun, 2035 (12 years from now)
US9949937	GW RES LTD	Use of cannabinoids in the treatment of epilepsy	Jun, 2035 (12 years from now)
US9956186	GW RES LTD	Use of cannabinoids in the treatment of epilepsy	Jun, 2035 (12 years from now)
US10092525	GW RES LTD	Use of cannabinoids in the treatment of epilepsy	Jun, 2035 (12 years from now)
US9956183	GW RES LTD	Use of cannabinoids in the treatment of epilepsy	Jun, 2035 (12 years from now)
US10111840	GW RES LTD	Use of cannabinoids in the treatment of epilepsy	Jun, 2035 (12 years from now)
US10137095	GW RES LTD	Use of cannabinoids in the treatment of epilepsy	Jun, 2035 (12 years from now)
US10603288	GW RES LTD	Use of cannabinoids in the treatment of epilepsy	Jun, 2035 (12 years from now)
US10709671	GW RES LTD	Use of cannabinoids in the treatment of epilepsy	Jun, 2035 (12 years from now)
US10709674	GW RES LTD	Use of cannabinoids in the treatment of epilepsy	Jun, 2035 (12 years from now)
US9956184	GW RES LTD	Use of cannabinoids in the treatment of epilepsy	Jun, 2035 (12 years from now)
US9956185	GW RES LTD	Use of cannabinoids in the treatment of epilepsy	Jun, 2035 (12 years from now)
US10849860	GW RES LTD	Use of cannabinoids in the treatment of epilepsy	Jun, 2035 (12 years from now)
US10966939	GW RES LTD	Use of cannabinoids in the treatment of epilepsy	Jun, 2035 (12 years from now)
US10709673	GW RES LTD	Use of cannabinoids in the treatment of epilepsy	Jun, 2035 (12 years from now)
US11311498	GW RES LTD	Use of cannabinoids in the treatment of epilepsy	Jun, 2035 (12 years from now)
US11357741	GW RES LTD	Use of cannabinoids in the treatment of epilepsy	Jun, 2035 (12 years from now)
US11446258	GW RES LTD	Use of cannabinoids in the treatment of epilepsy	Jun, 2035 (12 years from now)
US11400055	GW RES LTD	Use of cannabidiol in the treatment of epilepsy	Oct, 2035 (12 years from now)
US11065209	GW RES LTD	Use of cannabidiol in the treatment of epilepsy	Oct, 2035 (12 years from now)
US10918608	GW RES LTD	Use of cannabidiol in the treatment of epilepsy	Oct, 2035 (12 years from now)
US11406623	GW RES LTD	Methods of treating tuberous sclerosis complex with cannabidiol and everolimus	Mar, 2041 (18 years from now)
US11160795	GW RES LTD	Methods of treating tuberous sclerosis complex with cannabidiol and everolimus	Mar, 2041 (18 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Sep 28, 2023
Orphan Drug Exclusivity (ODE)	Jul 31, 2027
New Patient Population (NPP)	Jul 31, 2023

Drugs and Companies using CANNABIDIOL ingredient

NCE-1 date: September, 2022

Market Authorisation Date: 28 September, 2018

Treatment: Use for the treatment of seizures associated with dravet syndrome; Use for the treatment of seizures associated with lennox-gastaut syndrome; Use in combination with clobazam for the treatment of seizures in patients with dravet syndrome; Use for the treatment of convulsive seizures in patients with lennox gastaut syndrome; Use for the treatment of drop seizures in patients with dravet syndrome; Use in combination with clobazam for the treatment of seizures in patients with lennox gastaut syndrome who have been previously treated with clobazam; Use in combination with clobazam for the treatment of seizures in patients with dravet syndrome who have been previously treated with clobazam; Use for the treatment of atonic seizures in patients with dravet syndrome; Use for the treatment of atonic seizures in patients with lennox-gastaut syndrome; Use for the treatment of drop seizures in patients with lennox-gastaut syndrome; Use in combination with clobazam for treatment of drop seizures in patients with lennox gastaut syndrome; Use for the treatment of seizures in patients with lennox-gastaut syndrome; Use for the treatment of seizures in patients with dravet syndrome; Use for reducing convulsive seizure frequency in patients with lennox gastaut syndrome; Use for reducing convulsive seizure frequency in patients with dravet syndrome; Use for the treatment of focal seizures in patients with dravet syndrome; Use in combination with clobazam for treatment of seizures in patients with lennox gastaut syndrome; Use for the treatment of convulsive seizures in patients with dravet syndrome; Use for the treatment of absence seizures in patients with dravet syndrome; Use for the treatment of absence seizures in patients with lennox-gastaut syndrome; Use for the treatment of seizures in patients with tuberous sclerosis complex; Use for the treatment of generalized seizures or focal seizures with impairment in patients with tuberous sclerosis complex; Use for reducing seizure frequency in patients with tuberous sclerosis complex; Use for the treatment of seizures associated with tuberous sclerosis complex in patients taking everolimus; Use for the treatment of seizures associated with tuberous sclerosis complex

Dosage: SOLUTION;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
100 mg/mL	28 Sep, 2022	10		01 Mar, 2041

Strength	Dosage	Availability
100MG/ML	SOLUTION;ORAL	Prescription

11. List of Erleada drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US9388159	JANSSEN BIOTECH	Substituted diazaspiroalkanes as androgen receptor modulators	Mar, 2027 (4 years from now)
US8445507	JANSSEN BIOTECH	Androgen receptor modulator for the treatment of prostate cancer and androgen receptor-associated diseases	Sep, 2030 (7 years from now)
US9481663	JANSSEN BIOTECH	Crystalline forms of an androgen receptor modulator	Jun, 2033 (10 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8802689	JANSSEN BIOTECH	Androgen receptor modulator for the treatment of prostate cancer and androgen receptor-associated diseases	Mar, 2027 (4 years from now)
US9987261	JANSSEN BIOTECH	Substituted diazaspiroalkanes as androgen receptor modulators	Mar, 2027 (4 years from now)
US9884054	JANSSEN BIOTECH	Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer	Sep, 2033 (10 years from now)
US10849888	JANSSEN BIOTECH	Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer	Sep, 2033 (10 years from now)
US10052314	JANSSEN BIOTECH	Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer	Sep, 2033 (10 years from now)
US10702508	JANSSEN BIOTECH	Anti-androgens for the treatment of non-metastatic castration-resistant prostate cancer	Apr, 2038 (15 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Feb 14, 2023
New Indication (I)	Sep 17, 2022

Drugs and Companies using APALUTAMIDE ingredient

NCE-1 date: February, 2022

Market Authorisation Date: 14 February, 2018

Treatment: Treatment of non-metastatic, castration-resistant prostate cancer (nm-crpc); Treatment of metastatic castration-sensitive prostate cancer (mcspc); Treatment in combination with orchiectomy of non-metastatic, castration-resistant prostate cancer (nmcrpc); Treatment in combination with a gnrh agonist of non-metastatic, castration-resistant prostate cancer (nm-crpc); Treatment in combination with a gnrh agonist of high risk non-metastatic, castration-resistant prostate cancer (nm-crpc); Treatment in combination with androgen deprivation therapy of non-metastatic, castration-resistant prostate cancer (nmcrpc) that improves metastasis free survival

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
60 mg	14 Feb, 2022	5		30 Apr, 2038

Strength	Dosage	Availability
60MG	TABLET;ORAL	Prescription

12. List of Firdapse drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11060128	CATALYST PHARMS	Methods of administering 3,4-diaminopyridine	Jun, 2032 (9 years from now)
US11274332	CATALYST PHARMS	Methods of administering 3,4-diaminopyridine	Jun, 2032 (9 years from now)
US11274331	CATALYST PHARMS	Methods of administering 3,4-diaminopyridine	Jun, 2032 (9 years from now)
US11268128	CATALYST PHARMS	Methods of administering 3,4-diaminopyridine	Jun, 2032 (9 years from now)
US10793893	CATALYST PHARMS	Methods of administering 3,4-diaminopyridine	May, 2034 (11 years from now)
US10626088	CATALYST PHARMS	Determining degradation of 3,4-diaminopyridine	Feb, 2037 (14 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Nov 28, 2023
Orphan Drug Exclusivity (ODE)	Nov 28, 2025
New Patient Population (NPP)	Sep 29, 2025

Drugs and Companies using AMIFAMPRIDINE PHOSPHATE ingredient

NCE-1 date: November, 2022

Market Authorisation Date: 28 November, 2018

Treatment: Method of treating lambert-eaton myasthenic syndrome with amifampridine

Dosage: TABLET;ORAL

Strength	Dosage	Availability
EQ 10MG BASE	TABLET;ORAL	Prescription

13. List of Galafold drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US11304940	AMICUS THERAP US	Methods of treating Fabry patients having renal impairment	May, 2038 (15 years from now)
US11426396	AMICUS THERAP US	Methods of treating Fabry patients having renal impairment	May, 2038 (15 years from now)
US11357764	AMICUS THERAP US	Methods of treating Fabry patients having renal impairment	May, 2038 (15 years from now)
US11376244	AMICUS THERAP US	Methods of treating Fabry patients having renal impairment	May, 2038 (15 years from now)
US11357765	AMICUS THERAP US	Methods of treating Fabry patients having renal impairment	May, 2038 (15 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9480682	AMICUS THERAP US	Methods for treatment of Fabry disease	May, 2027 (4 years from now)
US11241422	AMICUS THERAP US	Methods for treatment of Fabry disease	May, 2027 (4 years from now)
US10406143	AMICUS THERAP US	Methods for treatment of fabry disease	May, 2027 (4 years from now)
US10383864	AMICUS THERAP US	Methods for treatment of Fabry disease	May, 2027 (4 years from now)
US9000011	AMICUS THERAP US	Methods for treatment of Fabry disease	May, 2027 (4 years from now)
US9987263	AMICUS THERAP US	Methods for treatment of Fabry disease	May, 2027 (4 years from now)
US9999618	AMICUS THERAP US	Dosing regimens for the treatment of lysosomal storage diseases using pharmacological chaperones	Apr, 2028 (5 years from now)
US10925866	AMICUS THERAP US	Dosing regimens for the treatment of lysosomal storage diseases using pharmacological chaperones	Apr, 2028 (5 years from now)
US11033538	AMICUS THERAP US	Dosing regimens for the treatment of lysosomal storage diseases using pharmacological chaperones	Apr, 2028 (5 years from now)
US10525045	AMICUS THERAP US	Dosing regimens for the treatment of lysosomal storage diseases using pharmacological chaperones	Apr, 2028 (5 years from now)
USRE48608	AMICUS THERAP US	Method to predict response to pharmacological chaperone treatment of diseases	Feb, 2029 (6 years from now)
US9095584	AMICUS THERAP US	Method to predict response to pharmacological chaperone treatment of diseases	Feb, 2029 (6 years from now)
US8592362	AMICUS THERAP US	Method to predict response to pharmacological chaperone treatment of diseases	Feb, 2029 (6 years from now)
US10813921	AMICUS THERAP US	Method to predict response to pharmacological chaperone treatment of diseases	Feb, 2029 (6 years from now)
US11234972	AMICUS THERAP US	Methods of treating fabry disease in patients having the G9331A mutation in the GLA gene	Mar, 2037 (14 years from now)
US10076514	AMICUS THERAP US	Methods of treating fabry disease in patients having the G9331A mutation in the GLA gene	Mar, 2037 (14 years from now)
US11278540	AMICUS THERAP US	Methods of treating Fabry patients having renal impairment	May, 2038 (15 years from now)
US11357762	AMICUS THERAP US	Methods of treating Fabry patients having renal impairment	May, 2038 (15 years from now)
US10792279	AMICUS THERAP US	Methods of treating Fabry patients having renal impairment	May, 2038 (15 years from now)
US10792278	AMICUS THERAP US	Methods of treating Fabry patients having renal impairment	May, 2038 (15 years from now)
US10874656	AMICUS THERAP US	Methods of treating Fabry patients having renal impairment	May, 2038 (15 years from now)
US10874655	AMICUS THERAP US	Methods of treating fabry patients having renal impairment	May, 2038 (15 years from now)
US10874657	AMICUS THERAP US	Methods of treating Fabry patients having renal impairment	May, 2038 (15 years from now)
US10857142	AMICUS THERAP US	Methods of treating Fabry patients having renal impairment	May, 2038 (15 years from now)
US10849889	AMICUS THERAP US	Methods of treating Fabry patients having renal impairment	May, 2038 (15 years from now)
US10849890	AMICUS THERAP US	Methods of treating Fabry patients having renal impairment	May, 2038 (15 years from now)
US10857141	AMICUS THERAP US	Methods of treating Fabry patients having renal impairment	May, 2038 (15 years from now)
US10471053	AMICUS THERAP US	Methods of treating Fabry patients having renal impairment	May, 2038 (15 years from now)
US10251873	AMICUS THERAP US	Methods of treating fabry patients having renal impairment	May, 2038 (15 years from now)
US11357761	AMICUS THERAP US	Methods of treating Fabry patients having renal impairment	May, 2038 (15 years from now)
US10799491	AMICUS THERAP US	Methods of treating Fabry patients having renal impairment	May, 2038 (15 years from now)
US11357763	AMICUS THERAP US	Methods of treating fabry patients having renal impairment	May, 2038 (15 years from now)
US11389437	AMICUS THERAP US	Methods of treating Fabry patients having renal impairment	May, 2038 (15 years from now)
US11389436	AMICUS THERAP US	Methods of treating fabry patients having renal impairment	May, 2038 (15 years from now)
US11278538	AMICUS THERAP US	Methods of treating Fabry patients having renal impairment	May, 2038 (15 years from now)
US11278537	AMICUS THERAP US	Methods of treating Fabry patients having renal impairment	May, 2038 (15 years from now)
US11278536	AMICUS THERAP US	Methods of treating Fabry patients having renal impairment	May, 2038 (15 years from now)
US11278539	AMICUS THERAP US	Methods of treating Fabry patients having renal impairment	May, 2038 (15 years from now)
US11458128	AMICUS THERAP US	Methods of treating Fabry patients having renal impairment	May, 2038 (15 years from now)
US10806727	AMICUS THERAP US	Methods of treating fabry patients having renal impairment	May, 2038 (15 years from now)
US11357784	AMICUS THERAP US	Use of migalastat for treating Fabry disease in pregnant patients	Feb, 2039 (16 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Aug 10, 2023
Orphan Drug Exclusivity (ODE)	Aug 10, 2025

Drugs and Companies using MIGALASTAT HYDROCHLORIDE ingredient

NCE-1 date: August, 2022

Market Authorisation Date: 10 August, 2018

Treatment: The treatment of fabry patients; A method of reducing podocyte globotriaosylceramide (gl-3) in a fabry patient by administering migalastat; A method of reducing left ventricular mass index (lvmi) in a fabry patient by administering migalastat

Dosage: CAPSULE;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
123 mg	10 Aug, 2022	3		06 Feb, 2039

Strength	Dosage	Availability
EQ 123MG BASE	CAPSULE;ORAL	Prescription

14. List of Lokelma drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US10413569	ASTRAZENECA	Microporous zirconium silicate for the treatment of hyperkalemia	Feb, 2032 (9 years from now)
US11406662	ASTRAZENECA	Microporous zirconium silicate for the treatment of hyperkalemia	Feb, 2032 (9 years from now)
US8802152	ASTRAZENECA	Microporous zirconium silicate for the treatment of hyperkalemia	Apr, 2032 (9 years from now)
US8877255	ASTRAZENECA	Microporous zirconium silicate for the treatment of hyperkalemia	Oct, 2033 (10 years from now)
US10695365	ASTRAZENECA	Microporous zirconium silicate for the treatment of hyperkalemia	Oct, 2033 (10 years from now)
US9913860	ASTRAZENECA	Microporous zirconium silicate for the treatment of hyperkalemia	Oct, 2033 (10 years from now)
US10300087	ASTRAZENECA	Extended use zirconium silicate compositions and methods of use thereof	Oct, 2035 (12 years from now)
US9592253	ASTRAZENECA	Extended use zirconium silicate compositions and methods of use thereof	Oct, 2035 (12 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10398730	ASTRAZENECA	Microporous zirconium silicate for the treatment of hyperkalemia	Feb, 2032 (9 years from now)
US8808750	ASTRAZENECA	Microporous zirconium silicate for the treatment of hyperkalemia	Feb, 2032 (9 years from now)
US10335432	ASTRAZENECA	Microporous zirconium silicate for the treatment of hyperkalemia	Feb, 2032 (9 years from now)
US9844567	ASTRAZENECA	Microporous zirconium silicate for the treatment of hyperkalemia	Feb, 2032 (9 years from now)
US9861658	ASTRAZENECA	Microporous zirconium silicate for the treatment of hyperkalemia	Feb, 2032 (9 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	May 18, 2023
M	Apr 24, 2023

Drugs and Companies using SODIUM ZIRCONIUM CYCLOSILICATE ingredient

NCE-1 date: May, 2022

Market Authorisation Date: 18 May, 2018

Treatment: Treatment of hyperkalemia in adults

Dosage: FOR SUSPENSION;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
5 g/packet and 10 g/packet	18 May, 2022	5		14 Oct, 2035

Strength	Dosage	Availability
5GM/PACKET	FOR SUSPENSION;ORAL	Prescription
10GM/PACKET	FOR SUSPENSION;ORAL	Prescription

15. List of Lorbrena drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8680111	PFIZER	Macrocyclic derivatives for the treatment of diseases	Mar, 2033 (10 years from now)
US10420749	PFIZER	Crystalline form of lorlatinib free base	Jul, 2036 (13 years from now)
US11299500	PFIZER	Crystalline form of lorlatinib free base hydrate	Oct, 2038 (15 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11020376	PFIZER	Crystalline form of lorlatinib free base	Jul, 2036 (13 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Nov 2, 2023
Orphan Drug Exclusivity (ODE)	Mar 3, 2028
New Indication (I)	Mar 3, 2024

Drugs and Companies using LORLATINIB ingredient

NCE-1 date: November, 2022

Market Authorisation Date: 02 November, 2018

Treatment: Treatment of anaplastic lymphoma kinase (alk)-positive metastatic non-small cell lung cancer, progressed on: crizotinib + at least 1 other alk inhibitor for metastatic disease; Or alectinib, or ceritinib as first alk inhibitor for metastatic disease.; Treatment of adult patients with metastatic non-small cell lung cancer (nsclc) whose tumors are anaplastic lymphoma kinase (alk)-positive as detected by an fda-approved test

Dosage: TABLET;ORAL

16. List of Lutathera drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10596276	AAA USA INC	Stable, concentrated radionuclide complex solutions	Jul, 2038 (15 years from now)
US10596278	AAA USA INC	Stable, concentrated radionuclide complex solutions	Jul, 2038 (15 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Jan 26, 2023
Orphan Drug Exclusivity (ODE)	Jan 26, 2025

Drugs and Companies using LUTETIUM DOTATATE LU-177 ingredient

NCE-1 date: January, 2022

Market Authorisation Date: 26 January, 2018

Treatment: NA

Dosage: SOLUTION;INTRAVENOUS

17. List of Mavyret drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8648037	ABBVIE INC	Macrocyclic proline derived HCV serine protease inhibitors	Jan, 2032 (8 years from now)
US8937150	ABBVIE INC	Anti-viral compounds	May, 2032 (9 years from now)
USRE48923	ABBVIE INC	Crystal forms	May, 2035 (12 years from now)
US9321807	ABBVIE INC	Crystal forms	Jun, 2035 (12 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10028937	ABBVIE INC	Anti-viral compounds	Jun, 2030 (7 years from now)
US10039754	ABBVIE INC	Anti-viral compounds	Jun, 2030 (7 years from now)
US9586978	ABBVIE INC	Anti-viral compounds	Nov, 2030 (7 years from now)
US10028937 (Pediatric)	ABBVIE INC	Anti-viral compounds	Dec, 2030 (7 years from now)
US10039754 (Pediatric)	ABBVIE INC	Anti-viral compounds	Dec, 2030 (7 years from now)
US9586978 (Pediatric)	ABBVIE INC	Anti-viral compounds	May, 2031 (8 years from now)
US8648037 (Pediatric)	ABBVIE INC	Macrocyclic proline derived HCV serine protease inhibitors	Jul, 2032 (9 years from now)
US8937150 (Pediatric)	ABBVIE INC	Anti-viral compounds	Nov, 2032 (9 years from now)
US10286029	ABBVIE INC	Method for treating HCV	Mar, 2034 (11 years from now)
US11484534	ABBVIE INC	Methods for treating HCV	Mar, 2034 (11 years from now)
US11484534 (Pediatric)	ABBVIE INC	Methods for treating HCV	Sep, 2034 (11 years from now)
US10286029 (Pediatric)	ABBVIE INC	Method for treating HCV	Sep, 2034 (11 years from now)
USRE48923 (Pediatric)	ABBVIE INC	Crystal forms	Nov, 2035 (12 years from now)
US9321807 (Pediatric)	ABBVIE INC	Crystal forms	Dec, 2035 (12 years from now)
US11246866	ABBVIE INC	Solid pharmaceutical compositions for treating HCV	Jun, 2036 (13 years from now)
US11246866 (Pediatric)	ABBVIE INC	Solid pharmaceutical compositions for treating HCV	Dec, 2036 (13 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Aug 3, 2022
New Patient Population (NPP)	Apr 30, 2022
Orphan Drug Exclusivity (ODE)	Jun 10, 2028
New Dosing Schedule (D)	Sep 26, 2022
M	Apr 10, 2023
Pediatric Exclusivity (PED)	Feb 3, 2023

Drugs and Companies using GLECAPREVIR; PIBRENTASVIR ingredient

NCE-1 date: February, 2022

Market Authorisation Date: 03 August, 2017

Treatment: Treatment of chronic hepatitis c virus (hcv) genotype 1, 2, 3, 4, 5, or 6 in pediatric patients 3 to less than 12 years of age or weighing less than 45 kg; Treatment of chronic hepatitis c virus (hcv) genotype 1, 2, 3, 4, 5, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg

Dosage: TABLET;ORAL

18. List of Mektovi drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8178693	ARRAY BIOPHARMA INC	N3 alkylated benzimidazole derivatives as MEK inhibitors	Mar, 2023 (a month from now)
US7777050	ARRAY BIOPHARMA INC	N3 alkylated benzimidazole derivatives as MEK inhibitors	Mar, 2023 (a month from now)
US9562016	ARRAY BIOPHARMA INC	Preparation of and formulation comprising a MEK inhibitor	Oct, 2033 (10 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8193229	ARRAY BIOPHARMA INC	Method of treatment using N3 alkylated benzimidazole derivatives as MEK inhibitors	Mar, 2023 (a month from now)
US8513293	ARRAY BIOPHARMA INC	Methods of treating a hyperproliferative disorder or inhibiting cell growth in a mammal	Mar, 2023 (a month from now)
US10005761	ARRAY BIOPHARMA INC	Compounds and compositions as protein kinase inhibitors	Aug, 2030 (7 years from now)
US9850229	ARRAY BIOPHARMA INC	Compounds and compositions as protein kinase inhibitors	Aug, 2030 (7 years from now)
US9593100	ARRAY BIOPHARMA INC	Compounds and compositions as protein kinase inhibitors	Aug, 2030 (7 years from now)
US9314464	ARRAY BIOPHARMA INC	Compounds and compositions as protein kinase inhibitors	Jul, 2031 (8 years from now)
US9980944	ARRAY BIOPHARMA INC	Preparation of and formulation comprising a MEK inhibitor	Oct, 2033 (10 years from now)
US9598376	ARRAY BIOPHARMA INC	Preparation of and formulation comprising a MEK inhibitor	Oct, 2033 (10 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Jun 27, 2023
Orphan Drug Exclusivity (ODE)	Jun 27, 2025

Drugs and Companies using BINIMETINIB ingredient

NCE-1 date: June, 2022

Market Authorisation Date: 27 June, 2018

Treatment: Method of treating melanoma; Indicated in combination with encorafenib for the treatment of melanoma; Indicated in combination with encorafenib for the treatment of melanoma with a braf mutation; Indicated in combination with encorafenib for the treatment of melanoma mediated by a b-raf protein kinase; Treatment of melanoma with a braf mutation

Dosage: TABLET;ORAL

19. List of Mulpleta drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US7601746	SHIONOGI INC	Compounds exhibiting thrombopoietin receptor agonism	Sep, 2024 (1 year, 7 months from now)
US8889722	SHIONOGI INC	Pharmaceutical composition containing optically active compound having thrombopoietin receptor agonist activity, and intermediate therefor	Jul, 2028 (5 years from now)
US8530668	SHIONOGI INC	Pharmaceutical composition containing optically active compound having thrombopoietin receptor agonist activity, and intermediate therefor	Jan, 2030 (6 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9427402	SHIONOGI INC	Preparation for improving solubility of poorly soluble drug	Sep, 2031 (8 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Jul 31, 2023

Drugs and Companies using LUSUTROMBOPAG ingredient

NCE-1 date: July, 2022

Market Authorisation Date: 31 July, 2018

Treatment: Treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure

Dosage: TABLET;ORAL

20. List of Olumiant drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8158616	ELI LILLY AND CO	Azetidine and cyclobutane derivatives as JAK inhibitors	Jun, 2030 (7 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8420629	ELI LILLY AND CO	Azetidine and cyclobutane derivatives as JAK inhibitors	Mar, 2029 (6 years from now)
US9089574	ELI LILLY AND CO	Antiviral JAK inhibitors useful in treating or preventing retroviral and other viral infections	Nov, 2032 (9 years from now)
US11045474	ELI LILLY AND CO	Antiviral JAK inhibitors useful in treating or preventing coronaviridae infections	Nov, 2032 (9 years from now)
US9737469	ELI LILLY AND CO	Methods for treating hair loss disorders	Mar, 2033 (10 years from now)

Exclusivity	Exclusivity Expiration
New Indication (I)	May 10, 2025
New Chemical Entity Exclusivity (NCE)	May 31, 2023

Drugs and Companies using BARICITINIB ingredient

NCE-1 date: May, 2022

Market Authorisation Date: 31 May, 2018

Treatment: Treatment of rheumatoid arthritis; Treatment of coronavirus disease 2019 (covid-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ecmo); Treatment of adult patients with severe alopecia areata

Dosage: TABLET;ORAL

21. List of Omegaven drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10350186	FRESENIUS KABI USA	Treatment and prevention of liver disease associated with parenteral nutrition (PN)	Nov, 2024 (1 year, 9 months from now)
US9566260	FRESENIUS KABI USA	Treatment and prevention of liver disease associated with parenteral nutrition (PN)	Jul, 2025 (2 years from now)
US9629821	FRESENIUS KABI USA	Treatment and prevention of liver disease associated with parenteral nutrition (PN)	Jul, 2025 (2 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Jul 27, 2023
Orphan Drug Exclusivity (ODE)	Jul 27, 2025

Drugs and Companies using FISH OIL TRIGLYCERIDES ingredient

NCE-1 date: July, 2022

Market Authorisation Date: 27 July, 2018

Treatment: Treatment of parenteral nutrition-associated cholestasis in patients under the age of 12; Treatment of liver disease through nutrition for patients under the age of 12; Use for patients with parenteral nutrition associated cholestasis or parenteral nutrition associated liver disease

Dosage: EMULSION;INTRAVENOUS

22. List of Onpattro drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8334373	ALNYLAM PHARMS INC	Nuclease resistant double-stranded ribonucleic acid	May, 2025 (2 years from now)
US8168775	ALNYLAM PHARMS INC	Compositions and methods for inhibiting expression of transthyretin	Oct, 2029 (6 years from now)
US10240152	ALNYLAM PHARMS INC	Compositions and methods for inhibiting expression of transthyretin	Oct, 2029 (6 years from now)
US11079379	ALNYLAM PHARMS INC	Methods of treating transthyretin (TTR) mediated amyloidosis	Aug, 2035 (12 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9943539	ALNYLAM PHARMS INC	2′-methoxy substituted oligomeric compounds and compositions for use in gene modulations	Nov, 2023 (8 months from now)
US9943538	ALNYLAM PHARMS INC	2′-methoxy substituted oligomeric compounds and compositions for use in gene modulations	Nov, 2023 (8 months from now)
US8642076	ALNYLAM PHARMS INC	Lipid containing formulations	Oct, 2027 (4 years from now)
US8822668	ALNYLAM PHARMS INC	Lipid formulations for nucleic acid delivery	Apr, 2029 (6 years from now)
US9364435	ALNYLAM PHARMS INC	Lipid formulations for nucleic acid delivery	Apr, 2029 (6 years from now)
US11141378	ALNYLAM PHARMS INC	Lipid formulations for nucleic acid delivery	Apr, 2029 (6 years from now)
US8058069	ALNYLAM PHARMS INC	Lipid formulations for nucleic acid delivery	Apr, 2029 (6 years from now)
US8492359	ALNYLAM PHARMS INC	Lipid formulations for nucleic acid delivery	Apr, 2029 (6 years from now)
US9234196	ALNYLAM PHARMS INC	Compositions and methods for inhibiting expression of transthyretin	Oct, 2029 (6 years from now)
US8741866	ALNYLAM PHARMS INC	Compositions and methods for inhibiting expression of transthyretin	Oct, 2029 (6 years from now)
US8802644	ALNYLAM PHARMS INC	Lipid formulation	Oct, 2030 (7 years from now)
US8158601	ALNYLAM PHARMS INC	Lipid formulation	Nov, 2030 (7 years from now)

Exclusivity	Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Aug 10, 2025
New Chemical Entity Exclusivity (NCE)	Aug 10, 2023

Drugs and Companies using PATISIRAN SODIUM ingredient

NCE-1 date: August, 2022

Market Authorisation Date: 10 August, 2018

Treatment: Treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis

Dosage: SOLUTION;INTRAVENOUS

23. List of Oriahnn (copackaged) drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US7419983	ABBVIE INC	Gonadotropin-releasing hormone receptor antagonists and methods related thereto	Jul, 2024 (1 year, 5 months from now)
US7056927	ABBVIE INC	Gonadotropin-releasing hormone receptor antagonists and methods relating thereto	Sep, 2024 (1 year, 7 months from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11459305	ABBVIE INC	Processes for the preparation of uracil derivatives	Nov, 2028 (5 years from now)
US11045470	ABBVIE INC	Methods of treating heavy menstrual bleeding	Mar, 2034 (11 years from now)
US10881659	ABBVIE INC	Methods of treating heavy menstrual bleeding	Mar, 2034 (11 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Jul 23, 2023
New Product (NP)	May 29, 2023

Drugs and Companies using ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM ingredient

NCE-1 date: July, 2022

Market Authorisation Date: 29 May, 2020

Treatment: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids)

Dosage: CAPSULE;ORAL

24. List of Orilissa drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US7419983	ABBVIE INC	Gonadotropin-releasing hormone receptor antagonists and methods related thereto	Jul, 2024 (1 year, 5 months from now)
US7056927	ABBVIE INC	Gonadotropin-releasing hormone receptor antagonists and methods relating thereto	Sep, 2024 (1 year, 7 months from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7176211	ABBVIE INC	Gonadotropin-releasing hormone receptor antagonists and methods relating thereto	Jul, 2024 (1 year, 5 months from now)
US11344551	ABBVIE INC	Methods of treating heavy menstrual bleeding	Mar, 2034 (11 years from now)
US10537572	ABBVIE INC	Methods of administering elagolix	Sep, 2036 (13 years from now)
US10682351	ABBVIE INC	Methods of administering elagolix	Sep, 2036 (13 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Jul 23, 2023

Drugs and Companies using ELAGOLIX SODIUM ingredient

NCE-1 date: July, 2022

Market Authorisation Date: 23 July, 2018

Treatment: Management of moderate to severe pain associated with endometriosis; Use of elagolix 200 mg bid for 6 months to manage moderate to severe pain associated with endometriosis in premenopausal women to reduce dysmenorrhea and non-menstrual pelvic pain; Use of elagolix 200 mg bid for 6 months to manage moderate to severe pain associated with endometriosis in premenopausal women having dyspareunia associated with endometriosis; Management of moderate to severe pain associated with endometriosis using 150mg elagolix while co-administering rifampin; Management of moderate to severe pain associated with endometriosis using 150 mg elagolix while co-administering ketoconazole

Dosage: TABLET;ORAL

25. List of Pifeltro drug patents

Patent Number	Company	Patent Title	Patent Expiry	Activity Alert
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8486975	MSD MERCK CO	Non-nucleoside reverse transcriptase inhibitors	Oct, 2031 (8 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Aug 30, 2023
New Indication (I)	Sep 19, 2022
New Patient Population (NPP)	Jan 27, 2025

Drugs and Companies using DORAVIRINE ingredient

NCE-1 date: August, 2022

Market Authorisation Date: 30 August, 2018

Treatment: For use in combination with other antiretroviral agents for the treatment of hiv-1 as a replacement therapy in virologically suppressed adults with no history of treatment failure and no known substitutions associated with resistance to doravirine; For use in combination with other antiretroviral agents for the treatment of hiv-1 infection in adult patients with no prior antiretroviral treatment history; For use in combination with other antiretroviral agents to treat hiv-1 infection in pediatric patients weighing at least 35kg with no prior antiretroviral treatment history or to replace the current antiretroviral regimen if virologically suppressed

Dosage: TABLET;ORAL

26. List of Seysara drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8318706	ALMIRALL	Substituted tetracycline compounds	May, 2031 (8 years from now)
US9255068	ALMIRALL	Crystalline salts of (4S,4AS,5AR,12AS)-4-dimethylamino-3,10,12,12A-tetrahydroxy-7-[methoxy(methyl)amino)-methyl] acid amide and methods of using the same	Feb, 2033 (10 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9481639	ALMIRALL	Substituted tetracycline compounds for treatment of inflammatory skin disorders	Aug, 2028 (5 years from now)
US8513223	ALMIRALL	Substituted tetracycline compounds for treatment of inflammatory skin disorders	Dec, 2029 (6 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Oct 1, 2023

Drugs and Companies using SARECYCLINE HYDROCHLORIDE ingredient

NCE-1 date: October, 2022

Market Authorisation Date: 01 October, 2018

Treatment: A method for treating acne in inflammatory lesions of non-nodular moderate to severe acne vulgaris patients 9 years of age and older comprising administering sarecycline hydrochloride in 60 mg, 100 mg or 150 mg equivalent doses; A method for treating a patient 9 years of age and older suffering from an inflammatory skin disorder of non-nodular moderate to severe acne vulgaris comprising administering an effective amount of sarecycline hydrochloride; A method for treating a bacterial infection in inflammatory lesions of non-nodular moderate to severe acne vulgaris patients 9 years of age and older comprising administering an effective amount of sarecycline hydrochloride; A method for treating acne in inflammatory lesions of non-nodular moderate to severe acne vulgaris patients 9 years of age and older comprising administering an effective amount of sarecycline hydrochloride crystalline salt; A method for treating a bacterial infection in inflammatory lesions of non-nodular moderate to severe acne vulgaris patients 9 years of age and older comprising administering an effective amount of sarecycline hydrochloride crystalline salt

Dosage: TABLET;ORAL

27. List of Symdeko (copackaged) drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only 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 (3 years from now)
US10239867	VERTEX PHARMS INC	Modulators of ATP-binding cassette transporters	Apr, 2027 (4 years from now)
US8623905	VERTEX PHARMS INC	Modulators of ATP-binding cassette transporters	May, 2027 (4 years from now)
US7645789	VERTEX PHARMS INC	Indole derivatives as CFTR modulators	May, 2027 (4 years from now)
US7495103	VERTEX PHARMS INC	Modulators of ATP-binding cassette transporters	May, 2027 (4 years from now)
US7776905	VERTEX PHARMS INC	Modulators of ATP-binding cassette transporters	Jun, 2027 (4 years from now)
These 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 (2 years from now)
US8354427	VERTEX PHARMS INC	Modulators of ATP-binding cassette transporters	Jul, 2026 (3 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 (3 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 (3 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 (3 years from now)
US10022352	VERTEX PHARMS INC	Modulators of ATP-binding cassette transporters	Apr, 2027 (4 years from now)
US9974781	VERTEX PHARMS INC	Modulators of ATP-binding cassette transporters	Apr, 2027 (4 years from now)
US8598181	VERTEX PHARMS INC	Modulators of ATP-binding cassette transporters	May, 2027 (4 years from now)
US8324242	VERTEX PHARMS INC	Modulators of ATP-binding cassette transporters	Aug, 2027 (4 years from now)
US8415387	VERTEX PHARMS INC	Modulators of ATP-binding cassette transporters	Nov, 2027 (4 years from now)
US10646481	VERTEX PHARMS INC	Pharmaceutical composition and administrations thereof	Aug, 2029 (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 (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 (10 years from now)
US10058546	VERTEX PHARMS INC	Pharmaceutical compositions of (R)-1-(2,2-difluorobenzo[D][1,3]dioxo1-5-y1)-N-(1-(2,3-dihydroxypropy1)-6-fluoro-2-(1-hydroxy-2-methylpropan-2-y1)-1H-indol-5-y1) cyclopropanecarbox-amide and administration thereof	Jul, 2033 (10 years from now)
US10206877	VERTEX PHARMS INC	Pharmaceutical compositions for the treatment of cystic fibrosis transmembrane conductance regulator mediated diseases	Apr, 2035 (12 years from now)

Exclusivity	Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Dec 21, 2027
New Chemical Entity Exclusivity (NCE)	Feb 12, 2023
New Patient Population (NPP)	Jun 21, 2022

Drugs and Companies using IVACAFTOR; IVACAFTOR, TEZACAFTOR ingredient

NCE-1 date: February, 2022

Market Authorisation Date: 12 February, 2018

Treatment: Tezacaftor and ivacaftor for the treatment of patients with a mild to moderate clinical phenotype of cystic fibrosis having at least one cftr gene mutation that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence; Tezacaftor and ivacaftor for the treatment of cystic fibrosis in patients age 6 years and older who have a r117h mutation in the cftr gene; Tezacaftor and ivacaftor for the treatment of cystic fibrosis in patients who are homozygous for the f508del mutation or having at least one cftr gene mutation that is responsive to tezacaftor/ivacaftor based on in vitro data and/or clinical evidence; Treating cystic fibrosis patients ages 6 and older, who are homozygous for f508del or have at least 1 cftr gene mutation responsive to tezacaftor/ivacaftor, with tezacaftor and a solid composition comprising amorphous (<30% crystalline) ivacaftor; Treating cystic fibrosis patients ages 12 and older, who are homozygous for f508del or have at least 1 cftr gene mutation responsive to tezacaftor/ivacaftor, with tezacaftor and a solid composition comprising amorphous (<30% crystalline) ivacaftor; Treatment of cystic fibrosis in patients aged 6 years and older, who are homozygous for the f508del mutation or heterozygous for f508del and a second cftr mutation predicted to be responsive to tezacaftor/ivacaftor, with tezacaftor and ivacaftor; Treatment of cystic fibrosis in patients aged 12 years and older, who are homozygous for the f508del mutation or heterozygous for f508del and a second cftr mutation predicted to be responsive to tezacaftor/ivacaftor, with tezacaftor and ivacaftor; Treatment of cystic fibrosis in patients aged 12 and older, who are homozygous for the f508del mutation or have at least one cftr gene mutation that is responsive to tezacaftor/ivacaftor, with tezacaftor and ivacaftor; Treatment of cystic fibrosis in patients aged 6 and older, who are homozygous for the f508del mutation or have at least one cftr gene mutation that is responsive to tezacaftor/ivacaftor, with tezacaftor and ivacaftor; Treatment of cystic fibrosis in patients age 12 and older, who have two copies of the f508del mutation or who have at least one cftr mutation that is responsive to tezacaftor/ivacaftor, with the composition of claim 1 of us 10,081,621; Treatment of cystic fibrosis in patients ages 6 and older, who have two copies of the f508del mutation or one f508del mutation and a cftr mutation predicted to be responsive to tezacaftor/ivacaftor, with the composition of claim 1 of us 10,081,621; Treatment of cystic fibrosis in patients age 6 and older, who have two copies of the f508del mutation or who have at least one cftr mutation that is responsive to tezacaftor/ivacaftor, with the composition of claim 1 of us 10,081,621; Treatment of cystic fibrosis in patients ages 12 and older, who have two copies of the f508del mutation or one f508del mutation and a cftr mutation predicted to be responsive to tezacaftor/ivacaftor, with the composition of claim 1 of us 10,081,621; Tezacaftor and ivacaftor for the treatment of cystic fibrosis in patients who are homozygous for the f508del mutation or heterozygous for the f508del mutation and a second mutation that is responsive to tezacaftor/ivacaftor; Treatment of cystic fibrosis in patients 12 years and older, with a f508del or g551d cftr gene mutation and a a455e, 2789+5g->a, or 3849+10kbc->t mutation, comprising concurrent coadministration of the compositions of claim 1 of u.s patent 10058546; Treatment of cystic fibrosis in patients 6 years and older, with a f508del or g551d cftr gene mutation and a a455e, 2789+5g->, or 3849+10kbc->t mutation, comprising concurrent coadministration of the compositions of claim 1 of u.s. patent 10058546; Treatment of cf in patients 6 years and older who have a f508del or g551d cftr mutation and a 2nd mutation selected from r117h, a455e, 2789+5g->a, and 3849+10kbc->t, comprising concurrent coadministration of the compositions of claim 1 of us 10058546; Treatment of cf in patients 12 years and older who have a f508del or g551d cftr mutation and a 2nd mutation selected from r117h, a455e, 2789+5g->a, & 3849+10kbc->t, comprising concurrent coadministration of the compositions of claim 1 of us 10058546; Treatment of cystic fibrosis in patients ages 12 and older, who have two copies of the f508del mutation or one f508del mutation and a cftr mutation predicted to be responsive to tezacaftor/ivacaftor, with the composition of claim 1 of us 10,206,877; Treatment of cystic fibrosis in patients ages 6 and older, who have two copies of the f508del mutation or one f508del mutation and a cftr mutation predicted to be responsive to tezacaftor/ivacaftor, with the composition of claim 1 of us 10,206,877; Treatment of cystic fibrosis in patients age 6 and older, who have two copies of the f508del mutation or at least one cftr mutation that is responsive to tezacaftor/ivacaftor, with the composition of claim 1 of us 10,206,877; Treatment of cystic fibrosis in patients age 12 and older, who have two copies of the f508del mutation or at least one cftr mutation that is responsive to tezacaftor/ivacaftor, with the composition of claim 1 of us 10,206,877; Treatment of cystic fibrosis in patients aged 6 years and older, who are homozygous for the f508del mutation or have at least one cftr mutation that is responsive to tezacaftor/ivacaftor, with an effective amount of tezacaftor and ivacaftor; Treatment of cystic fibrosis in patients aged 12 years and older, who are homozygous for the f508del mutation or have at least one cftr mutation that is responsive to tezacaftor/ivacaftor, with an effective amount of tezacaftor and ivacaftor

Dosage: TABLET;ORAL

28. List of Talzenna drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8420650	PFIZER	Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP)	Jul, 2029 (6 years from now)
US8012976	PFIZER	Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP)	Oct, 2029 (6 years from now)
US10189837	PFIZER	Crystalline (8S,9R)-5-fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-8,9-dihydro-2H-pyrido[4,3,2-de]phthalazin-3(7H)-one tosylate salt	Oct, 2031 (8 years from now)
US8735392	PFIZER	Crystalline (8S,9R)-5-fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-8,9-dihydro-2H-pyrido[4,3,2-de]phthalazin-3(7H)-one tosylate salt	Oct, 2031 (8 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9820985	PFIZER	Dihydropyridophthalazinone inhibitors of poly(ADP-ribose)polymerase (PARP)	Jul, 2029 (6 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Oct 16, 2023

Drugs and Companies using TALAZOPARIB TOSYLATE ingredient

NCE-1 date: October, 2022

Market Authorisation Date: 16 October, 2018

Treatment: Treatment of adult patients with deleterious or suspected deleterious germline breast cancer susceptibility gene (brca)-mutated (gbrcam) human epidermal growth factor receptor 2 (her2)-negative locally advanced or metastatic breast cancer

Dosage: CAPSULE;ORAL

29. List of Tavalisse drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8211889	RIGEL PHARMS INC	Prodrugs of 2,4-pyrimidinediamine compounds and their uses	Jan, 2026 (2 years from now)
US7538108	RIGEL PHARMS INC	Prodrugs of 2,4-pyrimidinediamine compounds and their uses	Mar, 2026 (3 years from now)
US7989448	RIGEL PHARMS INC	Prodrugs of 2,4-pyrimidinediamine compounds and their uses	Jun, 2026 (3 years from now)
US8163902	RIGEL PHARMS INC	Prodrugs of 2,4-pyrimidinediamine compounds and their uses	Jun, 2026 (3 years from now)
US7449458	RIGEL PHARMS INC	Prodrugs of 2,4-pyrimidinediamine compounds and their uses	Sep, 2026 (3 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
USRE48898	RIGEL PHARMS INC	Prodrugs of 2,4-pyrimidinediamine compounds and their uses	Jan, 2026 (2 years from now)
US9266912	RIGEL PHARMS INC	Prodrugs of 2,4-pyrimidinediamine compounds and their uses	Jan, 2026 (2 years from now)
US8912170	RIGEL PHARMS INC	Prodrugs of 2,4-pyrimidinediamine compounds and their uses	Jun, 2026 (3 years from now)
US9283238	RIGEL PHARMS INC	Prodrugs of 2,4-pyrimidinediamine compounds and their uses	Jun, 2026 (3 years from now)
US8445485	RIGEL PHARMS INC	Prodrugs of 2,4-pyrimidinediamine compounds and their uses	Jun, 2026 (3 years from now)
US8652492	RIGEL PHARMS INC	Wet granulation using a water sequestering agent	Nov, 2028 (5 years from now)
US8263122	RIGEL PHARMS INC	Wet granulation using a water sequestering agent	Nov, 2030 (7 years from now)
US8771648	RIGEL PHARMS INC	(Trimethoxyphenylamino) pyrimidinyl formulations	Jul, 2032 (9 years from now)
US8951504	RIGEL PHARMS INC	(trimethoxyphenylamino) pyrimidinyl formulations	Jul, 2032 (9 years from now)

Exclusivity	Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Apr 17, 2025
New Chemical Entity Exclusivity (NCE)	Apr 17, 2023

Drugs and Companies using FOSTAMATINIB DISODIUM ingredient

NCE-1 date: April, 2022

Market Authorisation Date: 17 April, 2018

Treatment: Treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (itp) who have had an insufficient response to a previous treatment

Dosage: TABLET;ORAL

30. List of Tegsedi drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US7015315	AKCEA THERAPS	Gapped oligonucleotides	Mar, 2023 (a month from now)
US7101993	AKCEA THERAPS	Oligonucleotides containing 2′-O-modified purines	Sep, 2023 (7 months from now)
US8101743	AKCEA THERAPS	Modulation of transthyretin expression	Apr, 2025 (2 years from now)
US9061044	AKCEA THERAPS	Modulation of transthyretin expression	Apr, 2031 (8 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8697860	AKCEA THERAPS	Diagnosis and treatment of disease	Apr, 2031 (8 years from now)
US9399774	AKCEA THERAPS	Modulation of transthyretin expression	Apr, 2031 (8 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Oct 5, 2023
Orphan Drug Exclusivity (ODE)	Oct 5, 2025

Drugs and Companies using INOTERSEN SODIUM ingredient

NCE-1 date: October, 2022

Market Authorisation Date: 05 October, 2018

Treatment: Treatment of polyneuropathy of hereditary transthyretin amyloidosis

Dosage: SOLUTION;SUBCUTANEOUS

31. List of Tibsovo drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US9850277	SERVIER	Therapeutically active compositions and their methods of use	Jan, 2033 (9 years from now)
US9474779	SERVIER	Therapeutically active compositions and their methods of use	Aug, 2033 (10 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10610125	SERVIER	Methods and compositions for cell-proliferation-related disorders	Jun, 2030 (7 years from now)
US10717764	SERVIER	Therapeutically active compounds and their methods of use	Jan, 2033 (9 years from now)
US9968595	SERVIER	Pharmaceutical compositions of therapeutically active compounds	Mar, 2035 (12 years from now)
US10449184	SERVIER	Pharmaceutical compositions of therapeutically active compounds	Mar, 2035 (12 years from now)
US10799490	SERVIER	Pharmaceutical compositions of therapeutically active compounds	Mar, 2035 (12 years from now)
US10653710	SERVIER	Combination therapy for treating malignancies	Oct, 2036 (13 years from now)
US10980788	SERVIER	Therapy for treating malignancies	Jun, 2039 (16 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Jul 20, 2023
Orphan Drug Exclusivity (ODE)	Aug 25, 2028
New Indication (I)	May 25, 2025

Drugs and Companies using IVOSIDENIB ingredient

NCE-1 date: July, 2022

Market Authorisation Date: 20 July, 2018

Treatment: A method of treating a cancer characterized by an idh1 mutation where the cancer is relapsed or refractory acute myeloid leukemia (aml) and where the mutant idh1 has the ability to convert alpha-ketoglutarate into 2-hydroxyglutarate (2-hg); A method of treating a cancer characterized by an idh1 mutation where the cancer is newly diagnosed acute myeloid leukemia (aml) and where the mutant idh1 has the ability to convert alpha-ketoglutarate into 2-hydroxyglutarate (2-hg); A method of treating previously treated, locally advanced or metastatic cholangiocarcinoma characterized by an idh1 mutation; A method of treating a cancer characterized by an idh1 mutation where the cancer is newly diagnosed acute myeloid leukemia (aml); A method of treating a cancer characterized by an idh1 mutation where the cancer is relapsed or refractory acute myeloid leukemia (aml); Treatment of acute myeloid leukemia (aml) with an idh1 mutation; A method of treating acute myelogenous leukemia (aml) in a subject by administering a pharmaceutical composition where the aml is characterized by the presence of a mutant allele of idh1 and the aml is newly diagnosed; A method of treating acute myelogenous leukemia (aml) in a subject by administering a pharmaceutical composition where the aml is characterized by the presence of a mutant allele of idh1 and where the aml is relapsed/refractory; A method for treating newly diagnosed aml characterized by the presence of a mutant allele of idh1 selected from r132h, r132c, r132l, r132v, r132s and r132gf by administering ivosidenib and azacitidine; A method of treating previously treated, locally advanced or metastatic cholangiocarcinoma characterized by the presence of a mutant allele of idh1 by administering a once daily 500 mg oral dose to a subject that has not ingested a high-fat meal; Treating newly diagnosed acute myelogenous leukemia (aml) characterized by the presence of a mutant allele of idh1 by administering a once daily 500 mg oral dose to a subject that has not ingested a high-fat meal; Treating relapsed/refractory acute myelogenous leukemia (aml) characterized by the presence of a mutant allele of idh1 by administering a once daily 500 mg oral dose to a subject that has not ingested a high-fat meal; A method of treating a cancer characterized by an idh1 mutation where the cancer is acute myelogenous leukemia (aml); A method of treating a cancer characterized by an idh1 mutation wherein the cancer is previously treated, locally advanced or metastatic cholangiocarcinoma

Dosage: TABLET;ORAL

32. List of Tpoxx drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8124643	SIGA TECHNOLOGIES	Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases	Jun, 2024 (1 year, 4 months from now)
US9339466	SIGA TECHNOLOGIES	Polymorphic forms of ST-246 and methods of preparation	Mar, 2031 (8 years from now)
CN101702904A	SIGA TECHNOLOGIES	Chemicals, Compositions, And Methods For Treatment And Prevention Of Orthopoxvirus Infections And Associated Diseases	Aug, 2015 (7 years ago)
EP1638938A2	SIGA TECHNOLOGIES	Compounds, Compositions And Methods For Treatment And Prevention Of Orthopoxvirus Infections And Associated Diseases	Jun, 2024 (1 year, 4 months from now)
EP1638938A4	SIGA TECHNOLOGIES	Compounds, Compositions And Methods For Treatment And Prevention Of Orthopoxvirus Infections And Associated Diseases	Jun, 2024 (1 year, 4 months from now)
EP1638938B1	SIGA TECHNOLOGIES	Compounds, Compositions And Methods For Treatment And Prevention Of Orthopoxvirus Infections And Associated Diseases	Jun, 2024 (1 year, 4 months from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8802714	SIGA TECHNOLOGIES	Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases	Jun, 2024 (1 year, 4 months from now)
US8530509	SIGA TECHNOLOGIES	Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases	Jun, 2024 (1 year, 4 months from now)
US8039504	SIGA TECHNOLOGIES	Chemicals, compositions, and methods for treatment and prevention of orthopoxvirus infections and associated diseases	Jul, 2027 (4 years from now)
US9907859	SIGA TECHNOLOGIES	ST-246 liquid formulations and methods	Aug, 2031 (8 years from now)
US10576165	SIGA TECHNOLOGIES	ST-246 liquid formulations and methods	Aug, 2031 (8 years from now)
US9233097	SIGA TECHNOLOGIES	ST-246 liquid formulations	Aug, 2031 (8 years from now)
US7737168	SIGA TECHNOLOGIES	Compounds, compositions, and methods for treatment and prevention of orthopoxvirus infections and associated diseases	Sep, 2031 (8 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Jul 13, 2023

Drugs and Companies using TECOVIRIMAT ingredient

NCE-1 date: July, 2022

Market Authorisation Date: 18 May, 2022

Treatment: Treatment of human smallpox disease caused by variola virus in adults and pediatric patients weighing at least 13 kg; Tpoxx is indicated for the treatment of human smallpox disease in adults and pediatric patients weighing at least 3 kg

Dosage: SOLUTION;INTRAVENOUS

33. List of Vitrakvi drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US9127013	BAYER HEALTHCARE	Method of treatment using substituted pyrazolo[1,5-a] pyrimidine compounds	Oct, 2029 (6 years from now)
US8513263	BAYER HEALTHCARE	Substituted pyrazolo[1,5-a]pyrimidine compounds as Trk kinase inhibitors	Dec, 2029 (6 years from now)
US10172861	BAYER HEALTHCARE	Crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-A]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate	Nov, 2035 (12 years from now)
US10799505	BAYER HEALTHCARE	Crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-A]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate	Aug, 2036 (13 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9676783	BAYER HEALTHCARE	Method of treatment using substituted pyrazolo[1,5-A] pyrimidine compounds	Oct, 2029 (6 years from now)
US10047097	BAYER HEALTHCARE	Method of treatment using substituted pyrazolo[1,5-a] pyrimidine compounds	Oct, 2029 (6 years from now)
US10005783	BAYER HEALTHCARE	Method of treatment using substituted pyrazolo[1,5-a] pyrimidine compounds	Oct, 2029 (6 years from now)
US10774085	BAYER HEALTHCARE	Method of treatment using substituted pyrazolo[1,5-A] pyrimidine compounds	Oct, 2029 (6 years from now)
US9447104	BAYER HEALTHCARE	Method of treatment using substituted pyrazolo[1,5-a]pyrimidine compounds	Oct, 2029 (6 years from now)
US8865698	BAYER HEALTHCARE	Method of treatment using substituted pyrazolo[1,5-a]pyrimidine compounds	Oct, 2029 (6 years from now)
US9782414	BAYER HEALTHCARE	Crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-A]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate	Nov, 2035 (12 years from now)
US10137127	BAYER HEALTHCARE	Liquid formulations of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-A]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide	Apr, 2037 (14 years from now)
US10045991	BAYER HEALTHCARE	Methods of treating pediatric cancers	Apr, 2037 (14 years from now)
US10668072	BAYER HEALTHCARE	Liquid formulations of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide	Apr, 2037 (14 years from now)

Exclusivity	Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Nov 26, 2025
New Chemical Entity Exclusivity (NCE)	Nov 26, 2023

Drugs and Companies using LAROTRECTINIB SULFATE ingredient

NCE-1 date: November, 2022

Market Authorisation Date: 26 November, 2018

Treatment: Method of treating cancerous solid tumors; Method of treating solid tumors that exhibit an ntrk gene fusion after surgical resection; Method of treating neuroblastoma, glioma, thyroid, and breast cancer solid tumors that exhibit an ntrk gene fusion; Method of treating solid tumors that exhibit an ntrk gene fusion; Method of treating solid tumors that exhibit an ntrk fusion gene in a pediatric patient; Method of treating cmn, ifs, hgg, dipgs, ptc, soft tissue sarcoma, and spindle cell sarcoma solid tumors exhibiting an ntrk gene fusion in a pediatric patient with an oral solution

Dosage: SOLUTION;ORAL

34. List of Vitrakvi drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US9127013	BAYER HLTHCARE	Method of treatment using substituted pyrazolo[1,5-a] pyrimidine compounds	Oct, 2029 (6 years from now)
US8513263	BAYER HLTHCARE	Substituted pyrazolo[1,5-a]pyrimidine compounds as Trk kinase inhibitors	Dec, 2029 (6 years from now)
US10172861	BAYER HLTHCARE	Crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-A]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate	Nov, 2035 (12 years from now)
US10799505	BAYER HLTHCARE	Crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-A]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate	Aug, 2036 (13 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10774085	BAYER HLTHCARE	Method of treatment using substituted pyrazolo[1,5-A] pyrimidine compounds	Oct, 2029 (6 years from now)
US9676783	BAYER HLTHCARE	Method of treatment using substituted pyrazolo[1,5-A] pyrimidine compounds	Oct, 2029 (6 years from now)
US10005783	BAYER HLTHCARE	Method of treatment using substituted pyrazolo[1,5-a] pyrimidine compounds	Oct, 2029 (6 years from now)
US8865698	BAYER HLTHCARE	Method of treatment using substituted pyrazolo[1,5-a]pyrimidine compounds	Oct, 2029 (6 years from now)
US9447104	BAYER HLTHCARE	Method of treatment using substituted pyrazolo[1,5-a]pyrimidine compounds	Oct, 2029 (6 years from now)
US10047097	BAYER HLTHCARE	Method of treatment using substituted pyrazolo[1,5-a] pyrimidine compounds	Oct, 2029 (6 years from now)
US10813936	BAYER HLTHCARE	Crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-YL)-pyrazolo[1,5-A]pyrimidin-3-YL)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate	Nov, 2035 (12 years from now)
US10285993	BAYER HLTHCARE	Crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate	Nov, 2035 (12 years from now)
US9782414	BAYER HLTHCARE	Crystalline form of (S)-N-(5-((R)-2-(2,5-difluorophenyl)-pyrrolidin-1-yl)-pyrazolo[1,5-A]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate	Nov, 2035 (12 years from now)

Exclusivity	Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Nov 26, 2025
New Chemical Entity Exclusivity (NCE)	Nov 26, 2023

Drugs and Companies using LAROTRECTINIB SULFATE ingredient

NCE-1 date: November, 2022

Market Authorisation Date: 26 November, 2018

Treatment: Method of treating solid tumors that exhibit an ntrk gene fusion; Method of treating cancerous solid tumors; Method of treating neuroblastoma, glioma, thyroid, and breast cancer solid tumors that exhibit an ntrk gene fusion; Method of treating solid tumors that exhibit an ntrk gene fusion after surgical resection; Method of treating lung cancer, undifferentiated sarcoma, or colorectal cancer that exhibits an ntrk gene fusion; Method of treating solid tumors that exhibit an ntrk gene fusion in a pediatric patient

Dosage: CAPSULE;ORAL

35. List of Vizimpro drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US7772243	PFIZER	4-phenylamino-quinazolin-6-yl-amides	Aug, 2028 (5 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8623883	PFIZER	4-phenylamino-quinazolin-6-yl-amides	May, 2025 (2 years from now)
US10603314	PFIZER	Method for treating gefitinib resistant cancer	Feb, 2026 (3 years from now)
US10596162	PFIZER	Method for treating gefitinib resistant cancer	Feb, 2026 (3 years from now)

Exclusivity	Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Sep 27, 2025
New Chemical Entity Exclusivity (NCE)	Sep 27, 2023

Drugs and Companies using DACOMITINIB ingredient

NCE-1 date: September, 2022

Market Authorisation Date: 27 September, 2018

Treatment: First-line treatment of metastatic non small-cell lung cancer (nsclc) with egfr exon 19 deletions or exon 21 (l858r) substitution mutations as detected by an fda-approved test; Administering daily a unit dosage of an irreversible egfr inhibitor covalently binding as claimed for 1st line treatment of gefitinib of erlotinib resistant metastatic nsclc with egfr exon 19 deletion or exon 21 l858r substitution; Administering daily a unit dosage of an irreversible egfr inhibitor covalently binding as claimed for 1st line treatment of gefitinib or erlotinib resistant metastatic nsclc with egfr exon 19 deletion or exon 21 l858r substitution with t790m mutation

Dosage: TABLET;ORAL

36. List of Xofluza drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8987441	GENENTECH INC	Substituted polycyclic carbamoyl pyridone derivative prodrug	Sep, 2031 (8 years from now)
US10392406	GENENTECH INC	Substituted polycyclic pyridone derivatives and prodrugs thereof	Apr, 2036 (13 years from now)
US10759814	GENENTECH INC	Pharmaceutical compositions containing substituted polycyclic pyridone derivatives and prodrug thereof	Aug, 2037 (14 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9815835	GENENTECH INC	Substituted polycyclic carbamolypyridone derivative	Jun, 2030 (7 years from now)
US8927710	GENENTECH INC	Substituted polycyclic carbamoylpyridone derivative	May, 2031 (8 years from now)
US10633397	GENENTECH INC	Substituted polycyclic pyridone derivatives and prodrugs thereof	Apr, 2036 (13 years from now)
US11306106	GENENTECH INC	Pharmaceutical compositions containing substituted polycyclic pyridone derivatives and prodrug thereof	Aug, 2037 (14 years from now)
US11261198	GENENTECH INC	Process for preparing substituted polycyclic pyridone derivative and crystal thereof	Sep, 2038 (15 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Oct 24, 2023

Drugs and Companies using BALOXAVIR MARBOXIL ingredient

NCE-1 date: October, 2022

Market Authorisation Date: 23 November, 2020

Treatment: Method for treating influenza; Method for post-exposure prophylaxis of influenza

Dosage: FOR SUSPENSION;ORAL

37. List of Xospata drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8969336	ASTELLAS	Diamino heterocyclic carboxamide compound	Jan, 2031 (7 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9487491	ASTELLAS	Diamino heterocyclic carboxamide compound	Jul, 2030 (7 years from now)
US10786500	ASTELLAS	Stable pharmaceutical composition for oral administration	Jul, 2036 (13 years from now)

Exclusivity	Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Nov 28, 2025
New Chemical Entity Exclusivity (NCE)	Nov 28, 2023

Drugs and Companies using GILTERITINIB FUMARATE ingredient

NCE-1 date: November, 2022

Market Authorisation Date: 28 November, 2018

Treatment: Treatment of acute myeloid leukemia (aml)

Dosage: TABLET;ORAL

38. List of Yupelri drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US7910608	MYLAN IRELAND LTD	Biphenyl compounds useful as muscarinic receptor antagonists	Mar, 2025 (2 years from now)
US7585879	MYLAN IRELAND LTD	Biphenyl compounds useful as muscarinic receptor antagonists	Mar, 2025 (2 years from now)
US7288657	MYLAN IRELAND LTD	Biphenyl compounds useful as muscarinic receptor antagonists	Dec, 2025 (2 years from now)
US9765028	MYLAN IRELAND LTD	Crystalline freebase forms of a biphenyl compound	Jul, 2030 (7 years from now)
US10550081	MYLAN IRELAND LTD	Crystalline freebase forms of a biphenyl compound	Jul, 2030 (7 years from now)
US8541451	MYLAN IRELAND LTD	Crystalline freebase forms of a biphenyl compound	Aug, 2031 (8 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8034946	MYLAN IRELAND LTD	Biphenyl compounds useful as muscarinic receptor antagonists	Mar, 2025 (2 years from now)
US11247969	MYLAN IRELAND LTD	Biphenyl compounds useful as muscarinic receptor antagonists	Mar, 2025 (2 years from now)
US10343995	MYLAN IRELAND LTD	Biphenyl compounds useful as muscarinic receptor antagonists	Mar, 2025 (2 years from now)
US8053448	MYLAN IRELAND LTD	Biphenyl compounds useful as muscarinic receptor antagonists	Mar, 2025 (2 years from now)
US8273894	MYLAN IRELAND LTD	Biphenyl compounds useful as muscarinic receptor antagonists	Mar, 2025 (2 years from now)
US7491736	MYLAN IRELAND LTD	Biphenyl compounds useful as muscarinic receptor antagonists	Mar, 2025 (2 years from now)
US7550595	MYLAN IRELAND LTD	Biphenyl compounds useful as muscarinic receptor antagonists	Mar, 2025 (2 years from now)
US7521041	MYLAN IRELAND LTD	Biphenyl compounds useful as muscarinic receptor antagonists	Mar, 2025 (2 years from now)
US10106503	MYLAN IRELAND LTD	Biphenyl compounds useful as muscarinic receptor antagonists	Mar, 2025 (2 years from now)
US11008289	MYLAN IRELAND LTD	Crystalline freebase forms of a biphenyl compound	Jul, 2030 (7 years from now)
US11484531	MYLAN IRELAND LTD	NA	Oct, 2039 (16 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Nov 9, 2023

Drugs and Companies using REVEFENACIN ingredient

NCE-1 date: November, 2022

Market Authorisation Date: 09 November, 2018

Treatment: For the maintenance treatment of patients with chronic obstructive pulmonary disease (copd)

Dosage: SOLUTION;INHALATION

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Drugs expiring in 2023

Drugs made by Eyepoint Pharms

Strength	Dosage	Availability
5GM/50ML (0.1GM/ML)	EMULSION;INTRAVENOUS	Prescription
10GM/100ML (0.1GM/ML)	EMULSION;INTRAVENOUS	Prescription

Strength	Dosage	Availability
EQ 150MG BASE	TABLET;ORAL	Prescription
EQ 200MG BASE	TABLET;ORAL	Prescription

Strength	Dosage	Availability
EQ 60MG BASE	TABLET;ORAL	Prescription
EQ 100MG BASE	TABLET;ORAL	Prescription
EQ 150MG BASE	TABLET;ORAL	Prescription

Strength	Dosage	Availability
75MG;75MG, 50MG	TABLET;ORAL	Prescription
150MG;150MG, 100MG	TABLET;ORAL	Prescription

Strength	Dosage	Availability
EQ 0.25MG BASE	CAPSULE;ORAL	Prescription
EQ 0.5MG BASE	CAPSULE;ORAL	Prescription
EQ 0.75MG BASE	CAPSULE;ORAL	Prescription
EQ 1MG BASE	CAPSULE;ORAL	Prescription

Pharsight

Drugs facing NCE-1 in 2022

1. List of Akynzeo drug patents

2. List of Annovera drug patents

3. List of Arakoda drug patents

4. List of Biktarvy drug patents

5. List of Braftovi drug patents

6. List of Copiktra drug patents

7. List of Daurismo drug patents

8. List of Delstrigo drug patents

9. List of Doptelet drug patents

10. List of Epidiolex drug patents

11. List of Erleada drug patents

12. List of Firdapse drug patents

13. List of Galafold drug patents

14. List of Lokelma drug patents

15. List of Lorbrena drug patents

16. List of Lutathera drug patents

17. List of Mavyret drug patents

18. List of Mektovi drug patents

19. List of Mulpleta drug patents

20. List of Olumiant drug patents

21. List of Omegaven drug patents

22. List of Onpattro drug patents

23. List of Oriahnn (copackaged) drug patents

24. List of Orilissa drug patents

25. List of Pifeltro drug patents

26. List of Seysara drug patents

27. List of Symdeko (copackaged) drug patents

28. List of Talzenna drug patents

29. List of Tavalisse drug patents

30. List of Tegsedi drug patents

31. List of Tibsovo drug patents

32. List of Tpoxx drug patents

33. List of Vitrakvi drug patents

34. List of Vitrakvi drug patents

35. List of Vizimpro drug patents

36. List of Xofluza drug patents

37. List of Xospata drug patents

38. List of Yupelri drug patents

availability in other generic markets.

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Other things you might be interested in