Drugs facing NCE-1 in 2023

Drugs becoming eligible for first Paragraph IV ANDA filing in 2023

1. Accrufer patent expiration

ACCRUFER's oppositions filed in EPO
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US9802973 SHIELD TX Crystalline forms of ferric maltol
Oct, 2035

(9 years from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9248148 SHIELD TX Mono (iron hydroxypyrone) and combination (iron hydroxypyrone and GI inflammation inhibiting agents) compositions for anaemia or H. pylori infections
Mar, 2031

(4 years from now)

US10179120 SHIELD TX Dosage regimen of ferric trimaltol
Jan, 2035

(8 years from now)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Jul 25, 2024
New Patient Population(NPP) Dec 19, 2028

Drugs and Companies using FERRIC MALTOL ingredient

NCE-1 date: 26 July, 2023

Market Authorisation Date: 25 July, 2019

Treatment: Method of treating iron deficiency

Dosage: CAPSULE

More Information on Dosage

ACCRUFER family patents

Family Patents

2. Aklief patent expiration

AKLIEF's oppositions filed in EPO
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7807708 GALDERMA Ligands that modulate RAR receptors and pharmaceutical/cosmetic compositions comprised thereof
Jul, 2031

(5 years from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8470871 GALDERMA Ligands that modulate RAR receptors
Dec, 2025

(3 months ago)

US8227507 GALDERMA Ligands that modulate RAR receptors
Dec, 2025

(3 months ago)

US9084778 GALDERMA Topical compositions containing a retinoid of the oil-in-water emulsion type
May, 2033

(7 years from now)

US9498465 GALDERMA Topical compositions in the form of a gel containing a particular solubilized retinoid
May, 2033

(7 years from now)




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

Drugs and Companies using TRIFAROTENE ingredient

NCE-1 date: 05 October, 2023

Market Authorisation Date: 04 October, 2019

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

Dosage: CREAM

How can I launch a generic of AKLIEF before its drug patent expiration?
More Information on Dosage

AKLIEF family patents

Family Patents

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

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3. Aubagio patent expiration

AUBAGIO's oppositions filed in EPO
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5459163 SANOFI Medicament to combat autoimmune diseases
Oct, 2012

(13 years ago)

US5679709 SANOFI Medicaments to combat autoimmune diseases
Oct, 2014

(11 years ago)

US6794410 SANOFI Use of (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4′-trifluoromethylphenyl)-amide for treating multiple sclerosis
Sep, 2026

(5 months from now)

US6794410

(Pediatric)

SANOFI Use of (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4′-trifluoromethylphenyl)-amide for treating multiple sclerosis
Mar, 2027

(11 months from now)

US8802735 SANOFI (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability
Sep, 2030

(4 years from now)

US8802735

(Pediatric)

SANOFI (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability
Mar, 2031

(4 years from now)

US9186346 SANOFI Methods for reducing the risk of an adverse teriflunomide and rosuvastatin interaction in multiple sclerosis patients
Feb, 2034

(7 years from now)

US9186346

(Pediatric)

SANOFI Methods for reducing the risk of an adverse teriflunomide and rosuvastatin interaction in multiple sclerosis patients
Aug, 2034

(8 years from now)




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

Drugs and Companies using TERIFLUNOMIDE ingredient

NCE-1 date: 31 October, 2023

Market Authorisation Date: 12 September, 2012

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

Dosage: TABLET

How can I launch a generic of AUBAGIO before its drug patent expiration?
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AUBAGIO family patents

Family Patents

4. Austedo patent expiration

AUSTEDO IPR and PTAB Proceedings
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8524733 TEVA Benzoquinoline inhibitors of vesicular monoamine transporter 2
Apr, 2031

(5 years from now)

US9550780 TEVA Formulations pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Sep, 2033

(7 years from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8524733

(Pediatric)

TEVA Benzoquinoline inhibitors of vesicular monoamine transporter 2
Oct, 2031

(5 years from now)

US9233959 TEVA Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Sep, 2033

(7 years from now)

US9814708 TEVA Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Sep, 2033

(7 years from now)

US11666566 TEVA Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Sep, 2033

(7 years from now)

US9296739 TEVA Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Sep, 2033

(7 years from now)

US9296739

(Pediatric)

TEVA Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Mar, 2034

(7 years from now)

US9233959

(Pediatric)

TEVA Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Mar, 2034

(7 years from now)

US9550780

(Pediatric)

TEVA Formulations pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Mar, 2034

(7 years from now)

US9814708

(Pediatric)

TEVA Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Mar, 2034

(7 years from now)

US11666566

(Pediatric)

TEVA Formulations and pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2
Mar, 2034

(7 years from now)

US12016858 TEVA Methods for the treatment of abnormal involuntary movement disorders
Mar, 2036

(9 years from now)

US11648244 TEVA Methods for the treatment of abnormal involuntary movement disorders
Mar, 2036

(9 years from now)

US11446291 TEVA Methods for the treatment of abnormal involuntary movement disorders
Mar, 2036

(9 years from now)

US11564917 TEVA Methods for the treatment of abnormal involuntary movement disorders
Mar, 2036

(9 years from now)

US10959996 TEVA Methods for the treatment of abnormal involuntary movement disorders
Mar, 2036

(9 years from now)

US11357772 TEVA Methods for the treatment of abnormal involuntary movement disorders
Mar, 2036

(9 years from now)

US11648244

(Pediatric)

TEVA Methods for the treatment of abnormal involuntary movement disorders
Sep, 2036

(10 years from now)

US11564917

(Pediatric)

TEVA Methods for the treatment of abnormal involuntary movement disorders
Sep, 2036

(10 years from now)

US10959996

(Pediatric)

TEVA Methods for the treatment of abnormal involuntary movement disorders
Sep, 2036

(10 years from now)

US12016858

(Pediatric)

TEVA Methods for the treatment of abnormal involuntary movement disorders
Sep, 2036

(10 years from now)

US11357772

(Pediatric)

TEVA Methods for the treatment of abnormal involuntary movement disorders
Sep, 2036

(10 years from now)

US11446291

(Pediatric)

TEVA Methods for the treatment of abnormal involuntary movement disorders
Sep, 2036

(10 years from now)

US11179386 TEVA Analogs of deutetrabenazine, their preparation and use
Mar, 2038

(11 years from now)

US11813232 TEVA Analogs of deutetrabenazine, their preparation and use
Mar, 2038

(11 years from now)

US11179386

(Pediatric)

TEVA Analogs of deutetrabenazine, their preparation and use
Sep, 2038

(12 years from now)

US11813232

(Pediatric)

TEVA Analogs of deutetrabenazine, their preparation and use
Sep, 2038

(12 years from now)




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

Drugs and Companies using DEUTETRABENAZINE ingredient

NCE-1 date: 25 December, 2023

Market Authorisation Date: 03 April, 2017

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

Dosage: TABLET

How can I launch a generic of AUSTEDO before its drug patent expiration?
More Information on Dosage

AUSTEDO family patents

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5. Balversa patent expiration

Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8895601 JANSSEN Pyrazolyl quinoxaline kinase inhibitors
Apr, 2033

(7 years from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9464071 JANSSEN Pyrazolyl quinoxaline kinase inhibitors
Apr, 2031

(5 years from now)

US9902714 JANSSEN Quinoxaline derivatives useful as FGFR kinase modulators
Mar, 2035

(8 years from now)

US12037644 JANSSEN Use of FGFR mutant gene panels in identifying cancer patients that will be responsive to treatment with an FGFR inhibitor
Oct, 2035

(9 years from now)

US10898482 JANSSEN Pharmaceutical compositions comprising N-(3,5-dimethoxyphenyl)-N'-1 methylethyl)-N-[3-(1-methyl-1H-pyrazol-4-yl)quinoxalin-6-yl]ethane-1,2-diamine
Feb, 2036

(9 years from now)

US11684620 JANSSEN Pharmaceutical compositions comprising N-(3,5-dimethoxyphenyl)-N′-(1-methylethyl)-N-[3-(1-methyl-1H-pyrazol-4-yl)quinoxalin-6-yl]ethane-1,2-diamine
Feb, 2036

(9 years from now)

US10478494 JANSSEN FGFR/PD-1 combination therapy for the treatment of cancer
Aug, 2036

(10 years from now)

US11077106 JANSSEN Cancer treatment
Feb, 2038

(11 years from now)




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

Drugs and Companies using ERDAFITINIB ingredient

NCE-1 date: 13 April, 2023

Market Authorisation Date: 12 April, 2019

Treatment: Treatment of adults with locally advanced or metastatic urothelial carcinoma with susceptible fgfr3 genetic alterations whose disease has progressed on or after at least one line of prior systemic the...

Dosage: TABLET

How can I launch a generic of BALVERSA before its drug patent expiration?
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BALVERSA family patents

Family Patents

6. Brukinsa patent expiration

Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US9447106 BEONE MEDICINES Substituted pyrazolo[1,5-a]pyrimidines as bruton's tyrosine kinase modulators
Apr, 2034

(8 years from now)

US10927117 BEONE MEDICINES Crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra-hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof
Aug, 2037

(11 years from now)

US11851437 BEONE MEDICINES Crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra-hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof
Aug, 2037

(11 years from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10570139 BEONE MEDICINES Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators
Apr, 2034

(8 years from now)

US11142528 BEONE MEDICINES Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators
Apr, 2034

(8 years from now)

US11884674 BEONE MEDICINES Crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra- hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof
Aug, 2037

(11 years from now)

US11591340 BEONE MEDICINES Crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra- hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof
Aug, 2037

(11 years from now)

US11970500 BEONE MEDICINES Crystalline form of (s)-7-(1-acryloylpiperidin-4-yl)- 2-(4-phenoxyphenyl)-4,5,6,7-tetra- hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof
Aug, 2037

(11 years from now)

US11701357 BEONE MEDICINES Treatment of B cell cancers using a combination comprising Btk inhibitors
Jun, 2039

(13 years from now)

US12233069 BEONE MEDICINES Oral solid tablet comprising Bruton's Tyrosine Kinase inhibitor and preparation method therefor
Jun, 2040

(14 years from now)

US11786531 BEONE MEDICINES Methods of treating B-cell proliferative disorder
Jan, 2043

(16 years from now)

US11896596 BEONE MEDICINES Methods of treating B-cell proliferative disorder
Jan, 2043

(16 years from now)

US11911386 BEONE MEDICINES Methods of treating B-cell proliferative disorder
Jan, 2043

(16 years from now)




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

Drugs and Companies using ZANUBRUTINIB ingredient

NCE-1 date: 15 November, 2023

Market Authorisation Date: 14 November, 2019

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

Dosage: CAPSULE; TABLET

How can I launch a generic of BRUKINSA before its drug patent expiration?
More Information on Dosage

BRUKINSA family patents

Family Patents

7. Caplyta patent expiration

CAPLYTA's oppositions filed in EPO
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
USRE39680 INTRA CELLULAR Substituted heterocycle fused gamma-carbolines
Jun, 2020

(5 years ago)

US7183282 INTRA CELLULAR Substituted heterocycle fused γ-carbolines
Jun, 2020

(5 years ago)

US9586960 INTRA CELLULAR 4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de] quinoxalin-8(7H)-yl)-1-(4-fluorophenyl)-1-butanone toluenesulfonic acid salt crystal forms
Mar, 2029

(2 years from now)

USRE48825 INTRA CELLULAR 4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de]quinoxalin-8(7H)-yl)-1-(4-fluorophenyl)-1-butanone toluenesulfonic acid salt crystal forms
Mar, 2029

(2 years from now)

US8648077 INTRA CELLULAR 4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de]quinoxalin-8(7H)-yl)-1-(4-fluorophenyl)-1-butanone toluenesulfonic acid addition salt and salt crystals
Dec, 2029

(3 years from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10464938 INTRA CELLULAR Pharmaceutical compositions comprising ((6bR,10aS)-1-(4-fluorophenyl)-4-(3-methyl-2,3,6b,9,10,10a-hexahydro-1H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de]quinoxalin-8(7H)-yl)butan-1-one or pharmaceutically acceptable salts thereof
Mar, 2028

(1 year, 11 months from now)

US9199995 INTRA CELLULAR 4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de]quinoxalin-8(7H)-yl)-1-(4-fluorophenyl)-1-butanone toluenesulfonic acid addition salt and salt crystals
Mar, 2029

(2 years from now)

US9616061 INTRA CELLULAR Methods and compositions for sleep disorders and other disorders
May, 2029

(3 years from now)

US10117867 INTRA CELLULAR Methods and compositions for sleep disorders and other disorders
May, 2029

(3 years from now)

US9168258 INTRA CELLULAR Methods and compositions for sleep disorders and other disorders
May, 2029

(3 years from now)

US8598119 INTRA CELLULAR Methods and compositions for sleep disorders and other disorders
Dec, 2029

(3 years from now)

USRE48839 INTRA CELLULAR Methods and compositions for sleep disorders and other disorders
Aug, 2033

(7 years from now)

US11026951 INTRA CELLULAR Methods of treating bipolar disorder
Dec, 2034

(8 years from now)

US9956227 INTRA CELLULAR Method for the treatment of residual symptoms of schizophrenia
Dec, 2034

(8 years from now)

US10960009 INTRA CELLULAR Methods of treating schizophrenia and depression
Dec, 2034

(8 years from now)

US12409176 INTRA CELLULAR Methods Of Treating Acute Depression
Mar, 2039

(12 years from now)

US11052084 INTRA CELLULAR Pharmaceutical capsule compositions comprising lumateperone mono-tosylate
Aug, 2039

(13 years from now)

US11690842 INTRA CELLULAR Pharmaceutical capsule compositions comprising lumateperone mono-tosylate
Aug, 2039

(13 years from now)

US10695345 INTRA CELLULAR Pharmaceutical capsule compositions comprising lumateperone mono-tosylate
Aug, 2039

(13 years from now)

US12128043 INTRA CELLULAR Pharmaceutical capsules comprising lumateperone mono-tosylate
Aug, 2039

(13 years from now)

US12070459 INTRA CELLULAR Pharmaceutical capsule compositions comprising lumateperone mono-tosylate
Aug, 2039

(13 years from now)

US11806348 INTRA CELLULAR Methods of treatment using pharmaceutical capsule compositions comprising lumateperone mono-tosylate
Aug, 2039

(13 years from now)

US11980617 INTRA CELLULAR Methods of treating acute depression and/or acute anxiety
Oct, 2039

(13 years from now)

US12090155 INTRA CELLULAR Methods
Jul, 2040

(14 years from now)

US12410195 INTRA CELLULAR Pharmaceutical Compositions Comprising 4-((6Br,10As)-3-Methyl-2,3,6B,9,10,10A-Hexahydro-1H-Pyrido[3′,4′:4,5]Pyrrolo[1,2,3-De]Quinoxalin-8(7H)-Yl)-1-(4-((6Br,10As)-3-Methyl-2,3,6B,9,10,10A-Hexahydro-1H-Pyrido[3′,4′:4,5]Pyrrolo[1,2,3-De]Quinoxalin-8(7H)-Yl)Phenyl)Butan-1-One For Treating Conditions Of The Central Nervous System And Cardiac Disorders
Dec, 2040

(14 years from now)

US11753419 INTRA CELLULAR 4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de]quinoxalin-8(7H)-yl)-1-(4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H-pyrido[3′4′:4,5]pyrrolo[1,2,3-de]quinoxalin-8(7H)-yl)phenyl)butan-1-one for treating conditions of the central nervous system and cardiac disorders
Dec, 2040

(14 years from now)

US12122792 INTRA CELLULAR Pharmaceutical compositions comprising 4-((6bR,10aS)-3-methyl2,3,6b,9,10,10a-hexahydro-1H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de]quinoxalin8(7H)-yl)-1-(4-((6bR,10aS)-3-methyl-2,3,6b,9,10,10a-hexahydro-1H-pyrido[3′,4′:4,5]pyrrolo[1,2,3-de]quinoxalin-8(7H)-yl)phenyl)butan-1-one for treating conditions of the central nervous system and cardiac disorders
Dec, 2040

(14 years from now)




Drug Exclusivity Drug Exclusivity Expiration
New Indication(I-882) Dec 17, 2024
New Chemical Entity Exclusivity(NCE) Dec 20, 2024
New Indication(I-904) Nov 05, 2028

Drugs and Companies using LUMATEPERONE TOSYLATE ingredient

NCE-1 date: 21 December, 2023

Market Authorisation Date: 22 April, 2022

Treatment: Modulation of 5-hydroxytryptamine 2 receptor activity in schizophrenia; Treatment of bipolar depression; Treatment of schizophrenia; Treatment of bipolar disorder i, bipolar disorder ii, or bipolar de...

Dosage: CAPSULE

How can I launch a generic of CAPLYTA before its drug patent expiration?
More Information on Dosage

CAPLYTA family patents

Family Patents

8. Dalvance patent expiration

DALVANCE's oppositions filed in EPO
Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7115564 ABBVIE Stable pharmaceutical compositions of dalbavancin and methods of administration
Nov, 2023

(2 years ago)

US7119061 ABBVIE Dalbavancin compositions for treatment of bacterial infections
Nov, 2023

(2 years ago)

US8143212 ABBVIE Dalbavancin compositions for treatment of bacterial infections
Nov, 2023

(2 years ago)

US6900175 ABBVIE Methods of administering dalbavancin for treatment of bacterial infections
May, 2028

(2 years from now)




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

Drugs and Companies using DALBAVANCIN HYDROCHLORIDE ingredient

NCE-1 date: 24 May, 2023

Market Authorisation Date: 23 May, 2014

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

Dosage: POWDER

How can I launch a generic of DALVANCE before its drug patent expiration?
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DALVANCE family patents

Family Patents

9. Exem Foam Kit patent expiration

Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9034300 GISKIT Composition and method for medical imaging of body cavities
Oct, 2030

(4 years from now)

US9259494 GISKIT Composition and method for medical imaging of body cavities
May, 2035

(9 years from now)

US9849199 GISKIT Composition and method for medical imaging of body cavities
Feb, 2036

(9 years from now)




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

Drugs and Companies using AIR POLYMER-TYPE A ingredient

NCE-1 date: 08 November, 2023

Market Authorisation Date: 07 November, 2019

Treatment: Use in sonohysterosalpinography to assess fallopian tube patency

Dosage: FOAM

More Information on Dosage

EXEM FOAM KIT family patents

Family Patents

10. Fetroja patent expiration

Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US9238657 SHIONOGI Cephalosporin having catechol group
Nov, 2033

(7 years from now)

US10004750 SHIONOGI Salt of cephalosporin derivative, its crystalline solid and a method of manufacturing thereof
Sep, 2035

(9 years from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9949982 SHIONOGI Preparation containing cephalosporin having a catechol moiety
Sep, 2035

(9 years from now)




Drug Exclusivity Drug Exclusivity Expiration
New Indication(I-844) Sep 25, 2023
New Chemical Entity Exclusivity(NCE) Nov 14, 2024
Generating Antibiotic Incentives Now(GAIN) Nov 14, 2029

Drugs and Companies using CEFIDEROCOL SULFATE TOSYLATE ingredient

NCE-1 date: 15 November, 2023

Market Authorisation Date: 14 November, 2019

Treatment: Method of treating hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (habp/vabp) comprising administering cefiderocol sulfate tosylate

Dosage: POWDER

More Information on Dosage

FETROJA family patents

Family Patents