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Last Updated: October 4, 2024

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ZEJULA Drug Patent Profile


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When do Zejula patents expire, and when can generic versions of Zejula launch?

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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Drug patent expirations by year for ZEJULA
Drug Prices for ZEJULA

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ZEJULA
Generic Entry Dates for ZEJULA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL
Generic Entry Dates for ZEJULA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Haider MahdiPhase 1
Zenith EpigeneticsPhase 1
Institute of Cancer Research, United KingdomPhase 2

See all ZEJULA clinical trials

Pharmacology for ZEJULA

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

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
>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.

Country Patent Number Title Estimated Expiration
Australia 2021245223 Niraparib compositions ⤷  Sign Up
New Zealand 586675 PHARMACEUTICALLY ACCEPTABLE SALTS OF 2-{ 4-[(3S)-PIPERIDIN-3- YL]PHENYL} -2H-INDAZOLE-7-CARBOXAMIDE ⤷  Sign Up
Malaysia 147789 AMIDE SUBSTITUTED INDAZOLES AS POLY(ADP-RIBOSE)POLYMERASE (PARP) INHIBITORS ⤷  Sign Up
Lithuania C2109608 ⤷  Sign Up
South Korea 101136702 ⤷  Sign Up
Brazil PI0417056 inibidores de reparo de dano no dna para tratamento de cáncer ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ZEJULA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1633724 C20150012 00136 Estonia ⤷  Sign Up PRODUCT NAME: OLAPARIIB;REG NO/DATE: EU/1/14/959 18.12.2014
2240466 122018000052 Germany ⤷  Sign Up PRODUCT NAME: NIRAPARIBTOSYLAT, EINSCHLIESSLICH NIRAPARIBTOSYLATMONOHYDRAT; REGISTRATION NO/DATE: EU/1/17/1235 20171116
2109608 667 Finland ⤷  Sign Up
2109608 2018/019 Ireland ⤷  Sign Up PRODUCT NAME: NIRAPARIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, STEREOISOMER OR TAUTOMER THEREOF, PARTICULARLY THE TOSYLATE OR A HYDRATE, ESPECIALLY THE TOSYLATE MONOHYDRATE.; REGISTRATION NO/DATE: EU/1/17/1235 20171116
1633724 CR 2015 00012 Denmark ⤷  Sign Up PRODUCT NAME: OLAPARIB, OG SALTE OG SOLVATER DERAF; REG. NO/DATE: EU/1/14/959/001 20141216
2240466 C201830027 Spain ⤷  Sign Up PRODUCT NAME: NIRAPARIB; NATIONAL AUTHORISATION NUMBER: EU/1/17/1235; DATE OF AUTHORISATION: 20171116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1235; DATE OF FIRST AUTHORISATION IN EEA: 20171116
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.