Drug Patents Expiring in 2022

1. Abilify patent expiration

ABILIFY'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.
US9359302 OTSUKA Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Sep, 2022

(2 years ago)

US8580796 OTSUKA Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Sep, 2022

(2 years ago)

US8642760 OTSUKA Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Sep, 2022

(2 years ago)




Drug Exclusivity Drug Exclusivity Expiration
Pediatric Exclusivity(PED) Aug 27, 2011
New Indication(I-616) Nov 19, 2012
New Indication(I-633) Feb 16, 2014
M(M-137) Jun 09, 2017
New Indication(I-700) Dec 12, 2017
Orphan Drug Exclusivity(ODE) Dec 12, 2021
Orphan Drug Exclusivity(ODE-80) Dec 12, 2021

Drugs and Companies using ARIPIPRAZOLE ingredient

Market Authorisation Date: 15 November, 2002

Treatment: Treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar i disorder, adjunctive treatment of major depressive disorder, and treatment of irritability associated ...

Dosage: TABLET; TABLET, ORALLY DISINTEGRATING

How can I launch a generic of ABILIFY before it's drug patent expiration?
More Information on Dosage

ABILIFY family patents

Family Patents

2. Abilify Maintena Kit patent expiration

ABILIFY MAINTENA KIT'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.
US8993761 OTSUKA PHARM CO LTD Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Sep, 2022

(2 years ago)




Drug Exclusivity Drug Exclusivity Expiration
New Dosage Form(NDF) Feb 28, 2016
M(M-150) Dec 05, 2017
New Indication(I-746) Jul 27, 2020

Drugs and Companies using ARIPIPRAZOLE ingredient

Market Authorisation Date: 28 February, 2013

Treatment: NA

Dosage: FOR SUSPENSION, EXTENDED RELEASE

How can I launch a generic of ABILIFY MAINTENA KIT before it's drug patent expiration?
More Information on Dosage

ABILIFY MAINTENA KIT family patents

Family Patents

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3. Abilify Mycite Kit patent expiration

ABILIFY MYCITE KIT'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.
US8642760 OTSUKA Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Sep, 2022

(2 years ago)

US9359302 OTSUKA Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Sep, 2022

(2 years ago)

US8580796 OTSUKA Low hygroscopic aripiprazole drug substance and processes for the preparation thereof
Sep, 2022

(2 years ago)




Drug Exclusivity Drug Exclusivity Expiration
M(M-150) Dec 05, 2017
New Indication(I-746) Jul 27, 2020

Drugs and Companies using ARIPIPRAZOLE ingredient

Market Authorisation Date: 13 November, 2017

Treatment: Adjunctive treatment of major depressive disorder (mdd)

Dosage: TABLET

More Information on Dosage

ABILIFY MYCITE KIT family patents

Family Patents

4. Addyi 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.
US7420057 SPROUT PHARMS Stable polymorph of flibanserin
Aug, 2022

(2 years ago)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Aug 18, 2020

Drugs and Companies using FLIBANSERIN ingredient

NCE-1 date: 19 August, 2019

Market Authorisation Date: 18 August, 2015

Treatment: NA

Dosage: TABLET

More Information on Dosage

ADDYI family patents

Family Patents

5. Bylvay 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.
US7132416 IPSEN Benzothiazepine and benzothiazepine derivatives with ileal bile acid transport (IBAT) inhibotory activity for the treatment hyperlipidaemia
Sep, 2022

(2 years ago)




Drug Exclusivity Drug Exclusivity Expiration
New Indication(I-918) Jun 13, 2026
New Chemical Entity Exclusivity(NCE) Jul 20, 2026
Orphan Drug Exclusivity(ODE-363) Jul 20, 2028
Orphan Drug Exclusivity(ODE-436) Jun 13, 2030

Drugs and Companies using ODEVIXIBAT ingredient

NCE-1 date: 20 July, 2025

Market Authorisation Date: 20 July, 2021

Treatment: NA

Dosage: CAPSULE, PELLETS; CAPSULE

More Information on Dosage

BYLVAY family patents

Family Patents

6. Cerdelga 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.
US6916802 GENZYME CORP Amino ceramide-like compounds and therapeutic methods of use
Apr, 2022

(2 years ago)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Aug 19, 2019
Orphan Drug Exclusivity(ODE) Aug 19, 2021
Orphan Drug Exclusivity(ODE-73) Aug 19, 2021

Drugs and Companies using ELIGLUSTAT TARTRATE ingredient

NCE-1 date: 19 August, 2018

Market Authorisation Date: 19 August, 2014

Treatment: Treatment of gaucher disease type 1

Dosage: CAPSULE

How can I launch a generic of CERDELGA before it's drug patent expiration?
More Information on Dosage

CERDELGA family patents

Family Patents

7. Epidiolex 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.
US10195159 JAZZ PHARMS RES Processes and apparatus for extraction of active substances and enriched extracts from natural products
May, 2022

(2 years ago)




Drug Exclusivity Drug Exclusivity Expiration
New Patient Population(NPP) Jul 31, 2023
New Chemical Entity Exclusivity(NCE) Sep 28, 2023
Orphan Drug Exclusivity(ODE-216) Sep 28, 2025
M(M-270) Oct 20, 2026
Orphan Drug Exclusivity(ODE-326) Jul 31, 2027
Orphan Drug Exclusivity(ODE-332) Jul 31, 2027

Drugs and Companies using CANNABIDIOL ingredient

NCE-1 date: 28 September, 2022

Market Authorisation Date: 28 September, 2018

Treatment: NA

Dosage: SOLUTION

How can I launch a generic of EPIDIOLEX before it's drug patent expiration?
More Information on Dosage

EPIDIOLEX family patents

Family Patents

8. Givlaari patent expiration

GIVLAARI's oppositions filed in EPO
Can you believe GIVLAARI received compensation for the extended wait time during the regulatory approval process?
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.
US8546143 ALNYLAM PHARMS INC Compositions and methods for inhibiting expression of a target gene
Jan, 2022

(2 years ago)




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

Drugs and Companies using GIVOSIRAN SODIUM ingredient

NCE-1 date: 21 November, 2023

Market Authorisation Date: 20 November, 2019

Treatment: Treatment of acute hepatic porphyria

Dosage: SOLUTION

More Information on Dosage

GIVLAARI family patents

Family Patents

9. Hetlioz 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.
US5856529 VANDA PHARMS INC Benzofuran and dihydrobenzofuran melatonergic agents
Dec, 2022

(1 year, 11 months ago)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Jan 31, 2019
Orphan Drug Exclusivity(ODE) Jan 31, 2021
Orphan Drug Exclusivity(ODE-59) Jan 31, 2021
New Indication(I-850) Dec 01, 2023
Orphan Drug Exclusivity(ODE-330) Dec 01, 2027

Drugs and Companies using TASIMELTEON ingredient

NCE-1 date: 31 January, 2018

Market Authorisation Date: 31 January, 2014

Treatment: Treatment of nighttime sleep disturbances in smith-magenis syndrome by administering tasimelteon

Dosage: CAPSULE

How can I launch a generic of HETLIOZ before it's drug patent expiration?
More Information on Dosage

HETLIOZ family patents

Family Patents

10. Hetlioz Lq 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.
US5856529 VANDA PHARMS INC Benzofuran and dihydrobenzofuran melatonergic agents
Dec, 2022

(1 year, 11 months ago)




Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Dec 01, 2023
Orphan Drug Exclusivity(ODE-329) Dec 01, 2027

Drugs and Companies using TASIMELTEON ingredient

Market Authorisation Date: 01 December, 2020

Treatment: Treatment of nighttime sleep disturbances in smith-magenis syndrome by administering tasimelteon

Dosage: SUSPENSION

More Information on Dosage

HETLIOZ LQ family patents

Family Patents

11. Leqvio patent expiration

LEQVIO's oppositions filed in EPO
Can you believe LEQVIO received compensation for the extended wait time during the regulatory approval process?
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.
US9074213 NOVARTIS Compositions and methods for inhibiting expression of a target gene
Mar, 2022

(2 years ago)

US8546143 NOVARTIS Compositions and methods for inhibiting expression of a target gene
Apr, 2022

(2 years ago)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Dec 22, 2026

Drugs and Companies using INCLISIRAN SODIUM ingredient

NCE-1 date: 22 December, 2025

Market Authorisation Date: 22 December, 2021

Treatment: As an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (hefh) or clinical atherosclerotic cardiovascular disease (ascv...

Dosage: SOLUTION

More Information on Dosage

LEQVIO family patents

Family Patents

12. Lynparza 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.
US7151102 ASTRAZENECA Phthalazinone derivatives
Apr, 2022

(2 years ago)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Dec 19, 2019
New Product(NP) Aug 17, 2020
New Indication(I-762) Jan 12, 2021
New Indication(I-776) Dec 19, 2021
Orphan Drug Exclusivity(ODE) Dec 19, 2021
Orphan Drug Exclusivity(ODE-83) Dec 19, 2021
New Indication(I-818) Dec 27, 2022
New Indication(I-831) May 08, 2023
New Indication(I-832) May 19, 2023
Orphan Drug Exclusivity(ODE-180) Aug 17, 2024
Orphan Drug Exclusivity(ODE-181) Aug 17, 2024
New Indication(I-885) Mar 11, 2025
Orphan Drug Exclusivity(ODE-226) Dec 19, 2025
New Indication(I-914) May 31, 2026
Orphan Drug Exclusivity(ODE-283) Dec 27, 2026
Orphan Drug Exclusivity(ODE-306) May 08, 2027

Drugs and Companies using OLAPARIB ingredient

NCE-1 date: 19 December, 2018

Market Authorisation Date: 17 August, 2017

Treatment: NA

Dosage: TABLET; CAPSULE

How can I launch a generic of LYNPARZA before it's drug patent expiration?
More Information on Dosage

LYNPARZA family patents

Family Patents

13. Macrilen 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.
US6861409 NOVO Growth hormone secretagogues
Aug, 2022

(2 years ago)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Dec 20, 2022
Orphan Drug Exclusivity(ODE-170) Dec 20, 2024

Drugs and Companies using MACIMORELIN ACETATE ingredient

NCE-1 date: 20 December, 2021

Market Authorisation Date: 20 December, 2017

Treatment: A method for the diagnosis of adult growth hormone deficiency by measuring the level of growth hormone after oral administration of macimorelin

Dosage: FOR SOLUTION

More Information on Dosage

MACRILEN family patents

Family Patents

14. Movantik 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.
US7662365 VALINOR Polymer conjugates of opioid antagonists
Oct, 2022

(2 years ago)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Sep 16, 2019

Drugs and Companies using NALOXEGOL OXALATE ingredient

NCE-1 date: 16 September, 2018

Market Authorisation Date: 16 September, 2014

Treatment: NA

Dosage: TABLET

How can I launch a generic of MOVANTIK before it's drug patent expiration?
More Information on Dosage

MOVANTIK family patents

Family Patents

15. Myrbetriq Granules patent expiration

MYRBETRIQ GRANULES 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.
US6346532 APGDI Amide derivatives or salts thereof
Mar, 2022

(2 years ago)




Drug Exclusivity Drug Exclusivity Expiration
New Product(NP) Mar 25, 2024
Pediatric Exclusivity(PED) Sep 25, 2024

Drugs and Companies using MIRABEGRON ingredient

Market Authorisation Date: 25 March, 2021

Treatment: NA

Dosage: FOR SUSPENSION, EXTENDED RELEASE

More Information on Dosage

MYRBETRIQ GRANULES family patents

Family Patents

16. Ocaliva 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.
US7138390 INTERCEPT PHARMS INC Steroids as agonists for FXR
Nov, 2022

(2 years ago)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) May 27, 2021
Orphan Drug Exclusivity(ODE) May 27, 2023
Orphan Drug Exclusivity(ODE-119) May 27, 2023

Drugs and Companies using OBETICHOLIC ACID ingredient

NCE-1 date: 27 May, 2020

Market Authorisation Date: 27 May, 2016

Treatment: NA

Dosage: TABLET

How can I launch a generic of OCALIVA before it's drug patent expiration?
More Information on Dosage

OCALIVA family patents

Family Patents

17. Pristiq patent expiration

PRISTIQ's oppositions filed in EPO
PRISTIQ 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.
US6673838 PF PRISM CV Succinate salt of O-desmethyl-venlafaxine
Mar, 2022

(2 years ago)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Mar 01, 2013
New Indication(I-675) Feb 14, 2016
M(M-222) Feb 06, 2021

Drugs and Companies using DESVENLAFAXINE SUCCINATE ingredient

NCE-1 date: 01 March, 2012

Market Authorisation Date: 20 August, 2014

Treatment: Maintenance treatment of major depressive disorder (mdd)

Dosage: TABLET, EXTENDED RELEASE

How can I launch a generic of PRISTIQ before it's drug patent expiration?
More Information on Dosage

PRISTIQ family patents

Family Patents

18. Promacta Kit 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.
US7160870 NOVARTIS Thrombopoietin mimetics
Nov, 2022

(2 years ago)




Drug Exclusivity Drug Exclusivity Expiration
New Dosing Schedule(D-149) Jun 11, 2018
New Indication(I-711) Jun 11, 2018
Orphan Drug Exclusivity(ODE) Aug 26, 2021
Orphan Drug Exclusivity(ODE-74) Aug 26, 2021
Pediatric Exclusivity(PED) Feb 26, 2022
ODE*(ODE*) Nov 16, 2025

Drugs and Companies using ELTROMBOPAG OLAMINE ingredient

Market Authorisation Date: 27 September, 2018

Treatment: Treatment of thrombocytopenia in patients with chronic hepatitis c to allow the initiation and maintenance of interferon-based therapy

Dosage: FOR SUSPENSION

How can I launch a generic of PROMACTA KIT before it's drug patent expiration?
More Information on Dosage

PROMACTA KIT family patents

Family Patents

19. Saxenda 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.
US6268343 NOVO Derivatives of GLP-1 analogs
Aug, 2022

(2 years ago)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Jan 25, 2015
New Product(NP) Jan 25, 2017
New Patient Population(NPP) Dec 04, 2023

Drugs and Companies using LIRAGLUTIDE ingredient

NCE-1 date: 25 January, 2014

Market Authorisation Date: 23 December, 2014

Treatment: Method for chronic weight management by treating obesity

Dosage: SOLUTION

How can I launch a generic of SAXENDA before it's drug patent expiration?
More Information on Dosage

SAXENDA family patents

Family Patents

20. Steglujan patent expiration

STEGLUJAN'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.
US6699871 MSD SUB MERCK Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes
Jul, 2022

(2 years ago)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Dec 19, 2022
M(M-275) Sep 17, 2024

Drugs and Companies using ERTUGLIFLOZIN; SITAGLIPTIN PHOSPHATE ingredient

NCE-1 date: 19 December, 2021

Market Authorisation Date: 19 December, 2017

Treatment: An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes

Dosage: TABLET

More Information on Dosage

STEGLUJAN family patents

Family Patents

21. Trulance patent expiration

TRULANCE'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.
US7799897 SALIX Guanylate cyclase receptor agonists for the treatment of tissue inflammation and carcinogenesis
Jun, 2022

(2 years ago)




Drug Exclusivity Drug Exclusivity Expiration
New Indication(I-764) Jan 24, 2021
New Chemical Entity Exclusivity(NCE) Jan 19, 2022

Drugs and Companies using PLECANATIDE ingredient

NCE-1 date: 19 January, 2021

Market Authorisation Date: 19 January, 2017

Treatment: NA

Dosage: TABLET

How can I launch a generic of TRULANCE before it's drug patent expiration?
More Information on Dosage

TRULANCE family patents

Family Patents

22. Viibryd patent expiration

VIIBRYD 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.
US8673921 ABBVIE Polymorphic forms of 1-[4-(5-cyanoindol-3-yl)butyl]-4-(2-carbamoylbenzofuran-5-yl) piperazine hydrochloride
Jun, 2022

(2 years ago)




Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Jan 21, 2016
New Dosing Schedule(D-146) Mar 16, 2018
M(M-254) Jan 31, 2023
Pediatric Exclusivity(PED) Jul 31, 2023

Drugs and Companies using VILAZODONE HYDROCHLORIDE ingredient

NCE-1 date: 31 July, 2022

Market Authorisation Date: 21 January, 2011

Treatment: NA

Dosage: TABLET

How can I launch a generic of VIIBRYD before it's drug patent expiration?
More Information on Dosage

VIIBRYD family patents

Family Patents

23. Xultophy 100/3.6 patent expiration

XULTOPHY 100/3.6'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.
US8846618 NOVO Stable formulation of modified GLP-1
Jun, 2022

(2 years ago)

US6268343 NOVO Derivatives of GLP-1 analogs
Aug, 2022

(2 years ago)




Drug Exclusivity Drug Exclusivity Expiration
New Combination(NC) Nov 21, 2019
New Chemical Entity Exclusivity(NCE) Sep 25, 2020
M(M-242) Aug 08, 2022

Drugs and Companies using INSULIN DEGLUDEC; LIRAGLUTIDE ingredient

NCE-1 date: 26 September, 2019

Market Authorisation Date: 21 November, 2016

Treatment: NA

Dosage: SOLUTION

More Information on Dosage

XULTOPHY 100/3.6 family patents

Family Patents

List of large molecules

1. List of Humira large molecules

Patent Number Company Patent Title Patent Expiry Activity Alert
US9546212 ABBVIE INC. Methods of administering anti-TNFα antibodies
Jun, 2022

(2 years ago)

US8911737 ABBVIE INC. Methods of administering anti-TNFα antibodies
Jun, 2022

(2 years ago)

US8974790 ABBVIE INC. Methods of administering anti-TNFα antibodies
Jun, 2022

(2 years ago)

US8992926 ABBVIE INC. Methods of administering anti-TNFα antibodies
Jun, 2022

(2 years ago)

Ingredients: ADALIMUMAB

2. List of Lucentis large molecules

Patent Number Company Patent Title Patent Expiry Activity Alert
US6828121 GENENTECH, INC. Bacterial host strains
Jul, 2022

(2 years ago)

US9688775 GENENTECH, INC. System for antibody expression and assembly
Dec, 2022

(1 year, 11 months ago)

Ingredients: RANIBIZUMAB