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, 2038. This may change due to patent challenges or generic licensing.

There have been seven 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
Takeda	PHASE2
Korean Cancer Study Group	PHASE2
Korea University Anam Hospital	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:

Australia

Brazil

Canada

China

Eurasian Patent Organization

European Patent Office

Israel

Japan

Mexico

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
South Africa	201003902
South Africa	200903898
Lithuania	C1633724
Russian Federation	2006105652	ТРИЦИКЛИЧЕСКИЕ ИНГИБИТОРЫ ПАРП

Supplementary Protection Certificates for ZEJULA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2240466	SPC/GB18/018	United Kingdom		PRODUCT NAME: NIRAPARIB TOSYLATE OR A HYDRATE THEREOF, ESPECIALLY THE TOSYLATE MONOHYDRATE; REGISTERED: UK EU/1/17/1235 20171120; UK PLGB 19494/0294 20171120
2240466	18C1020	France		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
3490560	CA 2025 00023	Denmark		PRODUCT NAME: NIRAPARIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN PARTICULAR NIRAPARIB TOSYLATE IN PARTICU-LAR NIRAPARIB TOSYLATE MONOHYDRATE, OPTIONALLY IN COMBINATION WITH ABIRATERONE IN PARTICULAR ABI-RATERONE ACETATE; REG. NO/DATE: EU/1/23/1722 20230420
2109608	C20180013 00262	Estonia		PRODUCT NAME: NIRAPARIIB;REG NO/DATE: EU/1/17/1235 20.11.2017

Market Dynamics and Financial Trajectory for Zejula (Niraparib)

Last updated: July 27, 2025

Introduction

Zejula (niraparib) stands as a prominent PARP inhibitor approved by the U.S. Food and Drug Administration (FDA) in 2017 for the 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. Developed and marketed by GlaxoSmithKline (GSK), Zejula’s market trajectory reflects broader trends in targeted oncology, driven by shifts toward personalized medicine and the expanding importance of PARP inhibitors in oncology therapeutics.

This analysis explores Zejula’s market dynamics, competitive landscape, regulatory pipeline, and projected financial trajectory, emphasizing the influencing factors shaping its commercial success and growth prospects.

Market Overview and Key Drivers

Growing Incidence of Ovarian and BRCA-Related Cancers

Ovarian cancer remains a significant therapeutic challenge, with an estimated 19,880 new cases and 12,810 deaths in the U.S. in 2023 [1]. BRCA mutations and homologous recombination deficiency (HRD) significantly influence disease prognosis and response to PARP inhibition. As genetic testing becomes more integrated into clinical workflows, identification of suitable patient populations for Zejula increases, expanding its potential market.

Expanding Indications

Initially approved for maintenance therapy, Zejula’s label has expanded. In November 2021, the FDA approved Zejula for first-line maintenance in advanced ovarian, fallopian tube, or primary peritoneal cancers regardless of BRCA mutation status, driven by the PRIMA study showing significant progression-free survival (PFS) benefits [2]. Additionally, regulatory bodies in Europe, Japan, and elsewhere have approved Zejula for various indications, broadening its geographic and clinical reach.

Competitive Landscape

Zejula faces competition primarily from other PARP inhibitors such as Lynparza (olaparib) by AstraZeneca/Merck and Rubraca (rucaparib) by Clovis. Each possesses unique approval profiles, but Zejula’s advantage lies in its broader indication expansion and oral administration convenience. The competitive dynamics are influenced heavily by trial outcomes, safety profiles, and pricing strategies.

Market Penetration Strategies

GSK’s strategic emphasis on comprehensive genetic testing partnerships, patient support programs, and differential pricing has contributed to Zejula’s penetration. Its utilization in combination therapies and potential expansion into earlier breast and other cancers exemplifies ongoing attempts to expand revenue streams.

Financial Trajectory and Market Performance

Revenue Trends

Since its launch, Zejula demonstrated rapid revenue growth driven by uptake in recurrent ovarian cancer maintenance. In 2022, GSK reported approximately GBP Contact your financial analyst or refer to the latest annual report for exact figures. The revenue is expected to continue ascending, especially with approval of Zejula in newly targeted indications and in high-prevalence tumor types like breast and prostate cancers.

R&D and Pipeline Developments

GSK has invested heavily in Zejula’s pipeline, exploring combinations with immunotherapies, anti-angiogenic agents, and chemotherapies. Key trials include the PACIFIC study for prostate cancer, which could unlock additional indications and revenue streams. Ongoing phase III trials aim to solidify Zejula's role in frontline settings and broader solid tumors.

Pricing and Reimbursement Considerations

Pricing strategies are aligned with the premium nature of targeted therapies. Cost-effectiveness assessments by health authorities influence reimbursement decisions, which impact accessibility and sales volume. GSK has engaged in negotiations with payers, striving for favorable access, particularly in emerging markets.

Regulatory Environment Impact

Global approvals and updated guidelines from entities like NCCN and ESMO influence Zejula's clinical adoption, subsequently affecting revenue trajectories. Patent protections and data exclusivity influence pricing power, but generic PARP inhibitors could threaten market share post-patent expiry.

Market Challenges and Opportunities

Generic Competition

The expiration of patents for certain PARP inhibitors poses a critical challenge, pressuring Zejula’s pricing and market share. GSK’s strategy involves differentiating Zejula through expanded indications, combination regimens, and biomarkers optimization.

Biomarker-Driven Precision Medicine

Advances in biomarker identification, especially homologous recombination deficiency (HRD) testing, enhance the precise targeting of Zejula, improving efficacy perceptions and clinician confidence, positively influencing sales.

Emerging Market Penetration

Emerging markets offer growth opportunities due to increasing cancer incidence and evolving healthcare infrastructures. GSK’s focus on local manufacturing, strategic partnerships, and patient assistance programs aims to capitalize on these markets.

Potential for Broader Oncology Applications

Early-phase trials investigating Zejula in breast, pancreatic, and prostate cancers suggest potential for expanded indications. Successful demonstration of efficacy could diversify revenue streams significantly.

Future Outlook and Revenue Projections

Medium to Long-Term Revenue Trends

Analysts project Zejula’s revenues to grow at a compound annual growth rate (CAGR) of approximately 10-15% over the next five years, contingent on successful trial outcomes and broadening of indications.

Impact of Combination Therapies

Combining Zejula with other immunotherapeutics or targeted agents could enhance its efficacy profile, fueling additional sales. GSK’s strategic collaborations with biotech firms and academia aim to expedite these initiatives.

Regulatory and Market Expansion

Regulatory approvals in China, India, and other emerging markets are expected to bolster Zejula’s global footprint, translating into increased revenues.

Risks to Financial Trajectory

Patent expiries, market saturation, emerging generics, and potential safety concerns pose risks to Zejula’s financial trajectory. Continual innovation, indication expansion, and efficient market access are critical for sustained growth.

Key Takeaways

• Zejula’s market growth is driven by expanding indications, heightened genetic testing, and competitive positioning as a broad-spectrum PARP inhibitor.
• The drug's revenue trajectory is expected to remain positive, bolstered by pipeline developments, combination therapies, and global market expansion.
• Competitive pressures and patent expiries necessitate ongoing innovation and strategic partnerships.
• Market opportunities reside in emerging economies and novel combination regimens, with potential for diversification into additional oncology indications.
• Regulatory wins and payer negotiations remain pivotal to maximizing Zejula's market access and profitability.

Conclusion

Zejula's market dynamics reflect the evolving landscape of targeted oncology therapies. Its financial trajectory hinges on sustained innovation, strategic indication expansion, and comprehensive market access strategies. As the oncology sector moves toward more personalized treatments, Zejula’s adaptability and clinical positioning will determine its long-term commercial success. Stakeholders should closely monitor ongoing clinical trials, regulatory milestones, and competitive moves to optimize investment and strategic decisions.

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FAQs

1. How does Zejula compare to other PARP inhibitors in terms of efficacy?
Zejula demonstrates comparable efficacy to other PARP inhibitors like Lynparza and Rubraca in ovarian cancer maintenance, with some studies suggesting broader applicability due to its approval regardless of BRCA mutation status. Its ongoing trials aim to further delineate comparative advantages.

2. What are the primary safety concerns associated with Zejula?
Common adverse effects include anemia, thrombocytopenia, neutropenia, and fatigue. Safety profiles have been acceptable in clinical trials, but long-term data and real-world evidence remain critical for further validation.

3. What is the potential of Zejula in non-ovarian cancers?
Preliminary studies indicate promising activity in breast, prostate, and pancreatic cancers, especially in tumors with HRD or BRCA mutations. Future approvals depend on trial outcomes demonstrating safety and efficacy.

4. How are global regulatory changes influencing Zejula’s market trajectory?
Regulatory approvals in key markets like Europe, Japan, and China facilitate broader access. Conversely, regulatory hurdles or delays can restrict growth, emphasizing the importance of proactive engagement with authorities.

5. What strategic measures can GSK adopt to sustain Zejula’s market leadership?
GSK can pursue indication expansion, invest in biomarker research, strengthen payer negotiations, explore combination regimens, and expand into emerging markets to maintain and grow Zejula’s market share.

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References

[1] American Cancer Society. Cancer Facts & Figures 2023.
[2] GSK Press Release, 2021. FDA Approves Zejula (niraparib) for First-Line Maintenance Therapy in Ovarian Cancer.