ZEJULA Drug Patent Profile

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 and one Paragraph IV challenge.

This drug has two hundred and eighty-five 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, 2031. This may change due to patent challenges or generic licensing.

There have been eleven 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

Summary for ZEJULA

International Patents:	285
US Patents:	8
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	61
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

See drug prices for ZEJULA

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

NDA:

208447

Dosage:

CAPSULE;ORAL

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
Korea University Anam Hospital	PHASE2
Takeda	PHASE2
Korean Cancer Study Group	PHASE2

See all ZEJULA clinical trials

Pharmacology for ZEJULA

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

Paragraph IV (Patent) Challenges for ZEJULA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZEJULA	Tablets	niraparib tosylate	100 mg, 200 mg and 300 mg	214876	1	2025-06-17

US Patents and Regulatory Information for ZEJULA

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

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

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			Y
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-002	Apr 26, 2023		RX	Yes	No				Y
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-003	Apr 26, 2023		RX	Yes	Yes
Glaxosmithkline	ZEJULA	niraparib tosylate	CAPSULE;ORAL	208447-001	Mar 27, 2017		DISCN	Yes	No

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:

Argentina

Australia

Austria

Brazil

Canada

Chile

China

Eurasian Patent Organization

European Patent Office

Israel

Japan

Malaysia

Mexico

Morocco

Philippines

Singapore

South Korea

Taiwan

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	2018246214	Niraparib compositions
Australia	2021245223	Niraparib compositions
Brazil	112019020211	composições de niraparib
Canada	3058375	COMPOSITIONS DE NIRAPARIB (NIRAPARIB COMPOSITIONS)

Supplementary Protection Certificates for ZEJULA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1633724	C300726	Netherlands		PRODUCT NAME: OLAPARIB, EN ZOUTEN EN; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
1633724	CR 2015 00012	Denmark		PRODUCT NAME: OLAPARIB, OG SALTE OG SOLVATER DERAF; REG. NO/DATE: EU/1/14/959/001 20141216
1633724	C20150012 00136	Estonia		PRODUCT NAME: OLAPARIIB;REG NO/DATE: EU/1/14/959 18.12.2014
1633724	92680	Luxembourg		PRODUCT NAME: OLAPARIB AINSI QUE DES SELS ET DES SOLVATES DE CELUI-CI. FIRST REGISTRATION: 20141218

DrugChatter Q&A for ZEJULA

Zejula efectos secundarios?
Zejula accelerated approval?
How much does zejula cost per month?
Zejula niraparib gsk primary differentiation 2025 2026?
Zejula patient assistance program?