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ZEJULA Drug Patent Profile

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When do Zejula patents expire, and what generic alternatives are available?

Zejula is a drug marketed by Glaxosmithkline and is included in two NDAs. There are eight patents protecting this drug.

This drug has two hundred and eighty patent family members in fifty-five countries.

The generic ingredient in ZEJULA is niraparib tosylate. One supplier is listed for this compound. Additional details are available on the niraparib tosylate profile page.

DrugPatentWatch^® Generic Entry Outlook for Zejula

Zejula was eligible for patent challenges on March 27, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 27, 2038. This may change due to patent challenges or generic licensing.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Summary for ZEJULA

International Patents:	280
US Patents:	8
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	60
Drug Prices:	Drug price information for ZEJULA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZEJULA
What excipients (inactive ingredients) are in ZEJULA?	ZEJULA excipients list
DailyMed Link:	ZEJULA at DailyMed

Drug patent expirations by year for ZEJULA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ZEJULA

Generic Entry Dates for ZEJULA^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 208447 Dosage: CAPSULE;ORAL
Generic Entry Dates for ZEJULA^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 214876 Dosage: TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ZEJULA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Zenith Epigenetics	Phase 1
Haider Mahdi	Phase 1
Royal Marsden NHS Foundation Trust	Phase 2

See all ZEJULA clinical trials

Pharmacology for ZEJULA

Drug Class	Poly(ADP-Ribose) Polymerase Inhibitor
Mechanism of Action	Poly(ADP-Ribose) Polymerase Inhibitors

US Patents and Regulatory Information for ZEJULA

ZEJULA is protected by nine US patents and three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZEJULA is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ZEJULA

Niraparib compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF TREATMENT OF OVARIAN CANCER OR FALLOPIAN TUBE CANCER

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF TREATMENT OF RECURRENT OVARIAN CANCER OR FALLOPIAN TUBE CANCER ASSOCIATED WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BRCA-MUTATION

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

DNA damage repair inhibitors for the treatment of cancer
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF TREATMENT OF ADVANCED OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER ASSOCIATED WITH HOMOLOGOUS RECOMBINATION DEFICIENCY (HRD) POSITIVE STATUS

Amide substituted indazoles as poly(ADP-ribose)polymerase(PARP) inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

DNA damage repair inhibitors for treatment of cancer
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF TREATMENT OF ADVANCED OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER ASSOCIATED WITH HOMOLOGOUS RECOMBINATION DEFICIENCY (HRD) POSITIVE STATUS

Pharmaceutically acceptable salts of 2-{4-[(3S)-piperidin-3-yl]phenyl}-2H-indazole-7-carboxamide
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Use of RNAI inhibiting PARP activity for the manufacture of a medicament for the treatment of cancer
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD OF TREATMENT OF ADVANCED OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER ASSOCIATED WITH HOMOLOGOUS RECOMBINATION DEFICIENCY (HRD) POSITIVE STATUS

FDA Regulatory Exclusivity protecting ZEJULA

INDICATED FOR MAINTENANCE TREATMENT OF ADULT PATIENTS WITH RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
Exclusivity Expiration: ⤷ Sign Up

TX OF ADULTS W/ ADV OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER TREATED W/ >=3 PRIOR CHEMO REGIMENS & CANCER ASSOCIATED W/ HRD+ STATUS DEFINED BY A DELETERIOUS OR SUSPECTED DELETERIOUS BRCA MUTATION
Exclusivity Expiration: ⤷ Sign Up

INDICATED FOR THE MAINTENANCE TREATMENT OF ADULT PATIENTS WITH ADVANCED EPITHELIAL OVARIAN CANCER WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-003	Apr 26, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-002	Apr 26, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-003	Apr 26, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-002	Apr 26, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Glaxosmithkline	ZEJULA	niraparib tosylate	CAPSULE;ORAL	208447-001	Mar 27, 2017		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-001	Apr 26, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-002	Apr 26, 2023		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for ZEJULA

When does loss-of-exclusivity occur for ZEJULA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 18246214
Patent: Niraparib compositions
Estimated Expiration: ⤷ Sign Up

Patent: 21245223
Patent: Niraparib compositions
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 2019020211
Patent: composições de niraparib
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 58375
Patent: COMPOSITIONS DE NIRAPARIB (NIRAPARIB COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up

China

Patent: 0944638
Patent: 尼拉帕尼组合物 (NIRAPARIB COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up

Eurasian Patent Organization

Patent: 1992177
Patent: КОМПОЗИЦИИ НА ОСНОВЕ НИРАПАРИБА
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 00314
Patent: COMPOSITIONS DE NIRAPARIB (NIRAPARIB COMPOSITIONS)
Estimated Expiration: ⤷ Sign Up

Israel

Patent: 9630
Patent: פורמולציות של ניראפריב (Niraparib formulations)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 20512350
Patent: ニラパリブ組成物
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 19011496
Patent: COMPOSICIONES DE NIRAPARIB. (NIRAPARIB COMPOSITIONS.)
Estimated Expiration: ⤷ Sign Up

Singapore

Patent: 201909011P
Patent: NIRAPARIB COMPOSITIONS
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 200014736
Patent: 니라파립 조성물
Estimated Expiration: ⤷ Sign Up

Taiwan

Patent: 61476
Estimated Expiration: ⤷ Sign Up

Patent: 1840315
Patent: NIRAPARIB compositions
Estimated Expiration: ⤷ Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ZEJULA around the world.

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Country	Patent Number	Title	Estimated Expiration
Cyprus	1110335		⤷ Sign Up
Taiwan	I338000		⤷ Sign Up
Brazil	112019020211	composições de niraparib	⤷ Sign Up
Australia	2009203598	Pharmaceutically acceptable salts of 2-{4-[(3S)-piperidin-3- yl]phenyl} -2H-indazole-7-carboxamide	⤷ Sign Up
China	1856572	Use of RNAi inhibiting parp activtiy for the manufacture of a medicament for the treatment of cancer	⤷ Sign Up
Poland	1684736		⤷ Sign Up
Chile	2008000046	COMPUESTOS DERIVADOS DE 2-(4-PIPERIDIN-3-IL-FENIL)-7-AMIDO-2,7A-DIHIDRO-1H-INDAZOL; COMPOSICION FARMACEUTICA QUE COMPRENDE A DICHOS COMPUESTOS; Y SU USO PARA TRATAR O PREVENIR EL CANCER, ENFERMEDADES INFLAMATORIAS, LESIONES POR REPERFUSION, AFECCIONE	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ZEJULA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2240466	18C1020	France	⤷ Sign Up	PRODUCT NAME: LE TOSYLATE DE NIRAPARIB OU L'UN DE SES HYDRATES,EN PARTICULIER LE TOSYLATE DE NIRAPARIB MONOHYDRATE; REGISTRATION NO/DATE: EU/1/17/1235 20171120
1633724	92680	Luxembourg	⤷ Sign Up	PRODUCT NAME: OLAPARIB AINSI QUE DES SELS ET DES SOLVATES DE CELUI-CI. FIRST REGISTRATION: 20141218
2109608	2018C/017	Belgium	⤷ Sign Up	PRODUCT NAME: NIRAPARIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, STEREOISOMEER OF TAUTOMEER, IN HET BIJZONDER HET TOSYLAAT OF EEN HYDRAAT, MEER IN HET BIJZONDER HET TOSYLAAT MONOHYDRAAT; AUTHORISATION NUMBER AND DATE: EU/1/17/1235 20171120
1633724	1590019-4	Sweden	⤷ Sign Up	PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REG. NO/DATE: EU/1/14/959 20141218
2109608	18C1019	France	⤷ Sign Up	PRODUCT NAME: NIRAPARIB OU L'UN DE SES SELS,STEREOISOMERES OU TAUTOMERES PHARMACEUTIQUEMENT ACCEPTABLES EN PARTICULIER LE TOSYLATE OU HYDRATE DE TOSYLATE,PLUS PARTICULIEREMENT LE TOSYLATE DE NIRAPARIB MONOHYDRATE; REGISTRATION NO/DATE: EU/1/17/1235 20171120
2109608	300937	Netherlands	⤷ Sign Up	PRODUCT NAME: NIRAPARIB, OF EEN TAUTOMEER DAARVAN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET TOSYLAAT OF EEN HYDRAAT, MEER IN HET BIJZONDER HET TOSYLAAT MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/17/1235 20171120
1633724	C20150012 00136	Estonia	⤷ Sign Up	PRODUCT NAME: OLAPARIIB;REG NO/DATE: EU/1/14/959 18.12.2014
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description