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 three 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ZEJULA
*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 |
| Institute of Cancer Research, United Kingdom | Phase 2 |
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
| 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 |
|---|---|---|---|
| Ecuador | SP056094 | DERIVADOS DE FTALAZINONA | ⤷ Sign Up |
| South Africa | 201003902 | PHARMACEUTICALLY ACCEPTABLE SALTS OF 2-{4-[(3S)-PIPERIDIN-3-YL]PHENYL}-2H-INDAZOLE-7-CARBOXAMIDE | ⤷ Sign Up |
| Lithuania | 2805945 | ⤷ Sign Up | |
| Russian Federation | 2413515 | ИНГИБИТОРЫ РЕПАРАЦИИ ПОВРЕЖДЕНИЯ ДНК ДЛЯ ЛЕЧЕНИЯ РАКА (DNA REPAIR INHIBITORS FOR CANCER THERAPY) | ⤷ Sign Up |
| Poland | 1633724 | ⤷ Sign Up | |
| Norway | 334610 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ZEJULA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2109608 | PA2018009 | Lithuania | ⤷ Sign Up | PRODUCT NAME: NIRAPAARIBAS ARBA JO FARMACISKAI PRIIMTINA DRUSKA, STEREOIZOMERAS ARBA TAUTOMERAS, BUTENT TOSILATAS ARBA HIDRATAS, YPATINGAI TOSILATO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/17/1235 20171116 |
| 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 | 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 | 213 50005-2015 | Slovakia | ⤷ Sign Up | PRODUCT NAME: OLAPARIB; REGISTRATION NO/DATE: EU/1/14/959 20141218 |
| 2109608 | SPC/GB18/016 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: NIRAPARIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PARTICULARLY THE TOSYLATE OR A HYDRATE, ESPECIALLY THE TOSYLATE MONOHYDRATE; REGISTERED: UK EU/1/17/1235 20171120; UK PLGB 19494/0294 20171120 |
| 2240466 | SPC/GB18/018 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: NIRAPARIB TOSYLATE OR A HYDRATE THEREOF, ESPECIALLY THE TOSYLATE MONOHYDRATE; REGISTERED: UK EU/1/17/1235 20171120; UK PLGB 19494/0294 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.
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