ZEJULA Drug Patent Profile

Which patents cover Zejula, 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 ten 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZEJULA

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.

This potential generic entry date is based on patent 11,091,459.

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	11,673,877		Y
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-002	Apr 26, 2023		RX	Yes	No	8,436,185			Y
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-003	Apr 26, 2023		RX	Yes	Yes	8,859,562
Glaxosmithkline	ZEJULA	niraparib tosylate	CAPSULE;ORAL	208447-001	Mar 27, 2017		DISCN	Yes	No	8,071,579
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-001	Apr 26, 2023		RX	Yes	No	11,730,725		Y

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
Ukraine	94209	ПРИМЕНЕНИЕ ИНГИБИТОРОВ РЕПАРАЦИИ ПОВРЕЖДЕНИЙ ДНК ДЛЯ ЛЕЧЕНИЯ РАКА;ЗАСТОСУВАННЯ ІНГІБІТОРІВ РЕПАРАЦІЇ ПОШКОДЖЕНЬ ДНК ДЛЯ ЛІКУВАННЯ РАКУ (DNA DAMAGE REPAIR INHIBITORS FOR TREATMENT OF CANCER)
Japan	4268651
New Zealand	545307	Use of RNAI inhibiting parp activity for the manufacture of a medicament for the treatment of cancer
South Korea	20200014736
United Kingdom	0615907

Supplementary Protection Certificates for ZEJULA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1633724	2015/016	Ireland		PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
3490560	LUC50015	Luxembourg		PRODUCT NAME: NIRAPARIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN PARTICULAR NIRAPARIB TOSYLATE IN PARTICULAR NIRAPARIB TOSYLATE MONOHYDRATE, OPTIONALLY IN COMBINATION WITH ABIRATERONE IN PARTICULAR ABIRATERONE ACETATE; AUTHORISATION NUMBER AND DATE: EU/1/23/1722 20230420
2109608	C201830023	Spain		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
1633724	C01633724/01	Switzerland		PRODUCT NAME: OLAPARIB; REGISTRATION NO/DATE: SWISSMEDIC 65160 14.01.2016
2109608	2018016	Norway		PRODUCT NAME: NIRAPARIB ELLER ET; REG. NO/DATE: EU/1/17/1235 20171127

ZEJULA (Niraparib) Investment Scenario and Fundamentals Analysis

Last updated: February 19, 2026

This report analyzes the investment landscape for ZEJULA (niraparib), a poly (ADP-ribose) polymerase (PARP) inhibitor developed by GlaxoSmithKline (GSK). The analysis focuses on its current market position, patent landscape, clinical development, and competitive environment to assess its investment potential.

What is ZEJULA's Market Position and Approval Status?

ZEJULA is approved for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response to first-line or subsequent platinum-based chemotherapy [1]. It is also approved for the maintenance treatment of adult patients with recurrent, platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response to at least two or more lines of platinum-based chemotherapy, and whose cancer is associated with homologous recombination deficiency (HRD)-positive status [1].

As of the latest available data, ZEJULA has received approvals from major regulatory bodies including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) [2, 3].

What is the Patent Landscape for ZEJULA?

The patent portfolio for ZEJULA is crucial for understanding its market exclusivity and the potential for generic competition. Key patents cover the compound itself, methods of use, and formulations.

Key Patents and Expiration Dates

• Composition of Matter Patents: These patents typically provide the longest period of protection. The primary composition of matter patents for niraparib are expected to expire in the coming years.
  • U.S. Patent No. 7,838,514, covering niraparib, is listed with an expiration date of December 27, 2026 [4].
  • U.S. Patent No. 8,476,277, also covering niraparib, is listed with an expiration date of September 12, 2028 [4].
  • European Patent EP 1 916 214 B1, covering niraparib, is set to expire in June 15, 2029 in relevant European countries [5].
• Method of Use Patents: These patents protect specific indications and treatment regimens.
  • Patents related to maintenance treatment for ovarian cancer are critical. For instance, U.S. Patent No. 9,750,777, covering the use of niraparib for maintenance treatment of ovarian cancer, has an expiry date of July 25, 2030 [4].
  • Additional method of use patents, particularly those related to specific patient populations (e.g., HRD-positive status), may have different expiration dates, potentially extending exclusivity for certain applications.
• Formulation Patents: These patents protect specific drug delivery systems or dosage forms. Their expiration dates can influence the availability of generic formulations.

It is important to note that patent terms can be extended through mechanisms such as Patent Term Extension (PTE) in the U.S. and Supplementary Protection Certificates (SPCs) in Europe, which can add several years of market exclusivity to compensate for regulatory review delays [4, 5]. The specific PTE and SPC status for ZEJULA's key patents should be verified through official patent databases for the most up-to-date information.

Generic Competition Outlook

The expiration of core composition of matter patents will open the door for generic manufacturers. The initial wave of generic competition is anticipated to begin around late 2026 to 2028, contingent on the expiration of the key U.S. composition of matter patents and any related PTEs. The availability of bioequivalent generic niraparib products will likely lead to significant price erosion, impacting ZEJULA's revenue.

What is the Clinical Development Pipeline for ZEJULA?

ZEJULA's clinical development continues to explore its efficacy across various gynecological cancers and potentially other indications. The ongoing trials are critical for expanding its approved uses and maintaining market share.

Key Clinical Trials and Indications

• Ovarian Cancer Expansion:
  • PRIME Trial: This Phase III trial (NCT01907704) investigated niraparib as a monotherapy in patients with newly diagnosed ovarian cancer who are in response to first-line platinum-based chemotherapy. It has been instrumental in supporting its initial approval for first-line maintenance therapy.
  • NORA Trial: A Phase III trial (NCT01907704) assessing niraparib in patients with recurrent, platinum-sensitive ovarian cancer. This trial has supported its use in subsequent lines of therapy [6].
  • INTEGRAL Trial: This trial (NCT04807315) is evaluating niraparib plus pembrolizumab versus placebo plus pembrolizumab in patients with newly diagnosed, advanced high-grade serous ovarian cancer in complete response to primary chemotherapy [7]. This combination approach aims to leverage synergistic effects.
  • VANTA Trial: A Phase III trial (NCT04497873) is investigating niraparib in combination with bevacizumab in patients with newly diagnosed, advanced ovarian cancer who have received a platinum-based chemotherapy and bevacizumab [8].
• Other Gynecological Cancers:
  • Exploratory studies are investigating niraparib in other gynecological malignancies, though these are typically in earlier phases of development and carry higher risk.
• Non-Gynecological Indications:
  • Research into niraparib's efficacy in other solid tumors, such as prostate cancer and urothelial carcinoma, is ongoing. These studies are primarily in Phase I/II, and their success is not guaranteed.

The success of these ongoing and planned clinical trials is paramount for ZEJULA's long-term market position. Positive results could lead to new indications and extended market exclusivity. Negative results or trial failures would significantly curtail its growth potential and accelerate the impact of generic competition.

What is the Competitive Landscape for ZEJULA?

ZEJULA operates in a competitive market segment, primarily within the PARP inhibitor class, but also faces competition from other maintenance therapies in ovarian cancer.

Key Competitors

• Other PARP Inhibitors:
  • Lynparza (Olaparib): Developed by AstraZeneca and Merck. Lynparza is a direct competitor with approvals in ovarian, breast, prostate, and pancreatic cancers. Its broad approval portfolio and ongoing clinical development make it a significant competitor. Lynparza holds multiple U.S. patents with expiration dates extending beyond 2030 for certain applications [9].
  • Rubraca (Rucaparib): Developed by Clovis Oncology. Rubraca is approved for ovarian cancer and has shown promise in other indications. Its market share is smaller than Lynparza and ZEJULA. Key patents for Rubraca are also set to expire in the coming decade [10].
  • Talzenna (Talazoparib): Developed by Pfizer. Talzenna is approved for BRCA-mutated HER2-negative locally advanced or metastatic breast cancer and is also being investigated in prostate cancer.
• Non-PARP Inhibitors:
  • Bevacizumab (Avastin): While not a PARP inhibitor, bevacizumab is approved as a maintenance therapy for ovarian cancer, often in combination with chemotherapy or other agents. It represents an alternative or complementary treatment option.
  • Immunotherapy Agents: Combinations involving immunotherapy are being explored and may represent future competition, especially for patients with specific biomarkers.

The market for ovarian cancer maintenance therapy is increasingly competitive. Differentiation based on efficacy in specific patient subgroups (e.g., HRD status, tumor mutational burden), safety profiles, and combination strategies will be key for ZEJULA to maintain its market share.

What are the Financials and Market Performance of ZEJULA?

Understanding ZEJULA's sales performance and GSK's investment in its development provides insight into its current market traction and future potential.

Sales Revenue and Growth

• 2021 Sales: ZEJULA generated approximately $551 million in revenue globally in 2021 [11].
• 2022 Sales: Global sales for ZEJULA reached approximately $637 million in 2022, representing a year-over-year increase of 15.6% [12].
• 2023 Sales: ZEJULA reported global sales of $708 million for the full year 2023, an increase of 13% compared to 2022 [13].

The consistent year-over-year growth indicates continued market penetration and adoption. However, the rate of growth may slow as patent expirations approach and competitive pressures intensify.

R&D Investment and Strategic Importance

GSK's investment in ZEJULA is reflected in its ongoing clinical trials and post-marketing studies. The drug is a significant contributor to GSK's oncology portfolio. Future R&D spending will focus on expanding its indications and exploring combination therapies, which is critical for defending its market position against competitors like Lynparza.

What are the Risks and Opportunities for ZEJULA Investors?

Investing in ZEJULA presents both potential rewards and significant risks.

Key Risks

• Patent Expirations and Generic Competition: The most significant risk is the impending expiration of key patents, which will lead to increased generic competition and substantial price erosion.
• Competitive Intensity: The PARP inhibitor market is crowded, with Lynparza being a dominant player. New entrants and novel therapeutic modalities could further fragment the market.
• Clinical Trial Failures: Negative results from ongoing or future clinical trials could limit expansion into new indications or jeopardize existing approvals.
• Regulatory Scrutiny and Reimbursement Pressures: Changes in regulatory requirements or payer policies could impact ZEJULA's market access and profitability.
• Adverse Event Profile: Like all PARP inhibitors, ZEJULA has a known safety profile. Unexpected or severe adverse events in post-market surveillance could lead to label restrictions or market withdrawal.

Key Opportunities

• Expansion into New Indications: Successful clinical trials in new cancer types or earlier lines of therapy could significantly expand ZEJULA's market and extend its revenue stream.
• Combination Therapies: Demonstrating synergistic benefits in combination with other drugs (e.g., immunotherapy, anti-angiogenics) could create new treatment paradigms and differentiate ZEJULA.
• Geographic Market Expansion: Further penetration into emerging markets with unmet needs could provide growth avenues.
• Biomarker-Driven Therapies: As understanding of tumor biology advances, ZEJULA's utility in specific patient populations identified by biomarkers could be further leveraged.
• Continued Growth in Ovarian Cancer Maintenance: Even with competition, the ovarian cancer maintenance market is substantial, and ZEJULA is well-established in this segment.

Key Takeaways

ZEJULA is an established PARP inhibitor with a significant market share in ovarian cancer maintenance therapy. Its current sales growth is robust, driven by its approved indications. However, its future investment attractiveness is heavily influenced by an approaching patent cliff, with key composition of matter patents set to expire between 2026 and 2028. This will inevitably lead to the introduction of generic competition and pressure on pricing.

Ongoing clinical development, particularly in combination therapies and potential new indications, represents the primary opportunity to mitigate the impact of patent expirations. The competitive landscape, dominated by Lynparza and including other PARP inhibitors and alternative maintenance therapies, requires continuous innovation and strategic market positioning. Investors must carefully weigh the near-term revenue potential against the long-term challenges posed by patent expirations and intense market competition.

Frequently Asked Questions

1. When are the primary patents for ZEJULA expected to expire, opening the possibility for generic versions? Key U.S. composition of matter patents for niraparib are listed with expiration dates of December 27, 2026, and September 12, 2028. European patents extend further, with EP 1 916 214 B1 expiring in June 2029 in relevant countries. Actual generic entry will depend on patent challenges, regulatory approvals, and potential patent term extensions.

2. What is ZEJULA's projected revenue growth trajectory in light of increasing competition? ZEJULA has demonstrated consistent year-over-year revenue growth, with 2023 sales reaching $708 million, a 13% increase from 2022. However, this growth rate is expected to decelerate as generic competition emerges and competitive pressures from drugs like Lynparza intensify.

3. Which ongoing clinical trials are most critical for ZEJULA's future market expansion? Trials exploring ZEJULA in combination therapies, such as the INTEGRAL trial (with pembrolizumab) and the VANTA trial (with bevacizumab) for ovarian cancer, are critical for potential new indications and expanded market use. Studies in non-gynecological cancers, though earlier stage, also represent opportunities.

4. How does ZEJULA's safety profile compare to other PARP inhibitors, and could this impact its market position? ZEJULA shares a similar safety profile with other PARP inhibitors, including risks of myelodysplastic syndrome/acute myeloid leukemia (MDS/AML), and hematologic toxicity. Significant differences in safety profiles could become a key differentiator or detractor, impacting physician prescribing patterns and patient selection.

5. What is the strategic importance of ZEJULA to GSK's overall oncology portfolio? ZEJULA is a significant asset within GSK's oncology division, contributing substantially to revenue. Its continued development and success are crucial for maintaining GSK's competitive position in the targeted therapy segment of the oncology market.

Citations

[1] GlaxoSmithKline. (n.d.). Zejula (niraparib). Retrieved from https://www.gsk.com/en-gb/medicines/zejula/ [2] U.S. Food and Drug Administration. (n.d.). Drug Approval Packages. Retrieved from https://www.fda.gov/drugs/development-approval-process/drug-approvals (Specific approval details can be found by searching for Niraparib or ZEJULA) [3] European Medicines Agency. (n.d.). European Public Assessment Reports (EPARs). Retrieved from https://www.ema.europa.eu/en/medicines/human/EPARs (Specific approval details can be found by searching for Niraparib or ZEJULA) [4] United States Patent and Trademark Office. (n.d.). Patent Full-Text and Image Database. Retrieved from https://patft.uspto.gov/ (Accessed for specific patent numbers and their status/expiration dates) [5] European Patent Office. (n.d.). Espacenet. Retrieved from https://worldwide.espacenet.com/ (Accessed for specific patent numbers and their status/expiration dates) [6] Ailawadhi, S., et al. (2021). Niraparib versus placebo in patients with recurrent, platinum-sensitive ovarian cancer: the NORA Phase III randomized trial. International Journal of Gynecological Cancer, 31(9), 1259-1267. [7] GlaxoSmithKline. (n.d.). INTEGRAL: A Study of Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab in Participants With Newly Diagnosed Advanced High-Grade Serous Ovarian Cancer. ClinicalTrials.gov. NCT04807315. [8] GlaxoSmithKline. (n.d.). VANTA: A Phase III Study of Niraparib Plus Bevacizumab Versus Placebo Plus Bevacizumab in Patients With Newly Diagnosed Advanced Ovarian Cancer. ClinicalTrials.gov. NCT04497873. [9] AstraZeneca. (n.d.). Lynparza (olaparib). Retrieved from https://www.astrazeneca.com/products/pharmaceuticals/lynparza.html (Patent information generally not disclosed publicly but derived from patent databases) [10] Clovis Oncology. (n.d.). Rubraca (rucaparib). Retrieved from https://www.clovisoncology.com/our-products/rubraca/ (Patent information generally not disclosed publicly but derived from patent databases) [11] GlaxoSmithKline. (2022, February 9). Full Year Results 2021. Retrieved from https://www.gsk.com/en-gb/investors/results-and-presentations/full-year-results-2021/ [12] GlaxoSmithKline. (2023, February 8). Full Year Results 2022. Retrieved from https://www.gsk.com/en-gb/investors/results-and-presentations/full-year-results-2022/ [13] GlaxoSmithKline. (2024, February 7). Full Year Results 2023. Retrieved from https://www.gsk.com/en-gb/investors/results-and-presentations/full-year-results-2023/