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Last Updated: March 28, 2024

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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 has been one patent litigation case 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

See drug prices for ZEJULA

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
University of California, San FranciscoPhase 1
Cancer Research UKPhase 3
UNICANCERPhase 3

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 ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD OF TREATMENT OF OVARIAN CANCER OR FALLOPIAN TUBE CANCER


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

DNA damage repair inhibitors for the treatment of cancer
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

DNA damage repair inhibitors for treatment of cancer
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Use of RNAI inhibiting PARP activity for the manufacture of a medicament for the treatment of cancer
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial

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: ⤷  Try a Trial

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: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline ZEJULA niraparib tosylate TABLET;ORAL 214876-002 Apr 26, 2023 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Glaxosmithkline ZEJULA niraparib tosylate TABLET;ORAL 214876-003 Apr 26, 2023 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Glaxosmithkline ZEJULA niraparib tosylate TABLET;ORAL 214876-002 Apr 26, 2023 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Glaxosmithkline ZEJULA niraparib tosylate CAPSULE;ORAL 208447-001 Mar 27, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glaxosmithkline ZEJULA niraparib tosylate TABLET;ORAL 214876-001 Apr 26, 2023 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Glaxosmithkline ZEJULA niraparib tosylate TABLET;ORAL 214876-002 Apr 26, 2023 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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
Estimated Expiration: ⤷  Try a Trial

Patent: 21245223
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2019020211
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 58375
Estimated Expiration: ⤷  Try a Trial

China

Patent: 0944638
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 1992177
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 00314
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 9630
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 20512350
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 19011496
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 201909011P
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 200014736
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 61476
Estimated Expiration: ⤷  Try a Trial

Patent: 1840315
Estimated Expiration: ⤷  Try a Trial

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
Russian Federation 2495035 ФАРМАЦЕВТИЧЕСКИ ПРИЕМЛЕМЫЕ СОЛИ 2-{4-[(3S)-ПИПЕРИДИН-3-ИЛ]ФЕНИЛ}-2Н-ИНДАЗОЛ-7-КАРБОКСАМИДА (PHARMACEUTICALLY ACCEPTABLE SALTS OF 2-{4-[(3S)-PIPERIDIN-3-YL]PHENYL}-2H-INDAZOLE-7-CARBOXAMIDE) ⤷  Try a Trial
Japan 5545772 ⤷  Try a Trial
Taiwan I528961 ⤷  Try a Trial
United Kingdom 0408524 ⤷  Try a Trial
Luxembourg C00072 ⤷  Try a Trial
Spain 2367433 ⤷  Try a Trial
El Salvador 2009003321 INDAZOLES SUSTITUIDOS CON AMIDA COMO INHIBIDORES DE POLI (ADP-RIBOSA)POLIMERASA (PARP) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ZEJULA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2109608 18C1019 France ⤷  Try a Trial 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
1633724 C 2015 011 Romania ⤷  Try a Trial PRODUCT NAME: OLAPARIB; NATIONAL AUTHORISATION NUMBER: EU/1/14/959/001; DATE OF NATIONAL AUTHORISATION: 20141216; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/959/001; DATE OF FIRST AUTHORISATION IN EEA: 20141216
2109608 C20180013 00262 Estonia ⤷  Try a Trial PRODUCT NAME: NIRAPARIIB;REG NO/DATE: EU/1/17/1235 20.11.2017
2109608 2018C/017 Belgium ⤷  Try a Trial 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
2240466 300938 Netherlands ⤷  Try a Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), MERGE
1633724 15C0022 France ⤷  Try a Trial PRODUCT NAME: OLAPARIB,SELS ET SOLVATES DE CELUI-CI; REGISTRATION NO/DATE: EU 1/14/959 20141218
2109608 1890020-9 Sweden ⤷  Try a Trial PRODUCT NAME: NIRAPARIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, STEREOISOMER OR TAUTOMER THEREOF, PARTICULARY THE TOSYLATE OR A HYDRATE, ESPECIALLY THE TOSYLATE MONOHYDRATE; REG. NO/DATE: EU/1/17/1235 20171120
>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.