Niraparib tosylate - Generic Drug Details

What are the generic sources for niraparib tosylate and what is the scope of patent protection?

Niraparib tosylate is the generic ingredient in one branded drug marketed by Glaxosmithkline and is included in two NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Niraparib tosylate has two hundred and eighty-five patent family members in fifty-five countries.

One supplier is listed for this compound.

Summary for niraparib tosylate

International Patents:	285
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	3
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for niraparib tosylate
DailyMed Link:	niraparib tosylate at DailyMed

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

Dosage:

CAPSULE;ORAL

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 niraparib tosylate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Ohio State University Comprehensive Cancer Center	Phase 2
Eli Lilly and Company	Phase 1
National Cancer Institute (NCI)	Phase 1

See all niraparib tosylate clinical trials

Pharmacology for niraparib tosylate

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

Anatomical Therapeutic Chemical (ATC) Classes for niraparib tosylate

L01XK	Poly (ADP-ribose) polymerase (PARP) inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for NIRAPARIB TOSYLATE

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 niraparib tosylate

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	214876-001	Apr 26, 2023		RX	Yes	No
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-002	Apr 26, 2023		RX	Yes	No
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-002	Apr 26, 2023		RX	Yes	No			Y

International Patents for niraparib tosylate

Country	Patent Number	Title	Estimated Expiration
Poland	1649017
Israel	273282	פורמולציות של ניראפריב (Niraparib formulations)
Taiwan	200505871	Phthalazinone derivatives

Supplementary Protection Certificates for niraparib tosylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3490560	PA2025528	Lithuania		PRODUCT NAME: NIRAPARIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, YPAC NIRAPARIBO TOZILATAS, YPAC NIRAPARIBO TOZILATO MONOHIDRATAS, PASIRINKTINAI DERINYJE SU ABIRATERONU, YPAC ABIRATERONO ACETATU; REGISTRATION NO/DATE: EU/1/23/1722 20230419
1633724	2015/016	Ireland		PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
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

Market Dynamics and Financial Trajectory for NIRAPARIB TOSYLATE

Last updated: April 14, 2026

What is NIRAPARIB TOSYLATE?

Niraparib tosylate is a PARP inhibitor approved for maintenance therapy in ovarian cancer. It is developed by GlaxoSmithKline (GSK) and gained approval by the FDA in March 2020, with subsequent approvals in Europe and other markets. The drug is designed to exploit deficiencies in DNA repair in cancer cells, leading to targeted cell death in BRCA-mutated ovarian cancers.

Market Size and Penetration

Current Market Scope

• Global ovarian cancer treatment market valued around USD 3 billion in 2022.
• PARP inhibitors accounted for approximately 65% of this segment, roughly USD 2 billion.
• Niraparib's market share in this class was about 35%, equating to USD 700 million in 2022.

Competitive Positioning

• Niraparib competes primarily with Olaparib (Lynparza, AstraZeneca) and Rucaparib (Rubraca, Clovis).
• Market penetration is higher in the U.S., with 45-50% of PARP inhibitor prescriptions in ovarian cancer, driven by FDA approval and insurance coverage.
• Adoption in Europe is growing, but slower due to varying reimbursement policies.

Prescription Trends

• Prescriptions increased at a compound annual growth rate (CAGR) of approximately 10% from 2020 to 2022.
• Major drivers include expanded indications and clinical guideline endorsements.

Regulatory and Reimbursement Landscape

• FDA approvals in 2020 for maintenance therapy post-chemotherapy.
• Regulatory decisions in Europe, Japan, and Australia followed in 2021-2022.
• Payor coverage remains strongest in North America, driving revenue.

Revenue and Sales Forecasts

Short-term (2023-2025)

• Revenue growth projected at a CAGR of 8-12%.
• Total sales estimated to reach USD 1 billion by 2025, assuming continued uptake and approval of additional indications (e.g., first-line therapy).

Year	Estimated Revenue	Notes
2023	USD 800 million	Market expansion, more prescriber adoption
2024	USD 900 million	Inclusion in broader treatment guidelines
2025	USD 1 billion	Potential approval for frontline use in ovarian cancer

Long-term (2025-2030)

• Potential expansion into non-ovarian cancers, including breast and prostate.
• Development of combination regimens with other targeted agents may accelerate growth.
• Revenue could exceed USD 2 billion globally if indications broaden and new markets open.

Clinical Trial Data and Pipeline Development

• Phase 3 trials show significant progression-free survival (PFS) benefits.
• Trials ongoing include combinations with immunotherapies and other targeted agents.
• Positive trial outcomes can drive off-label use and increase market size.

Key Market Risks

• Generic competition anticipated post-patent expiration, projected around 2028-2030.
• Pricing pressures due to payor pushback and biosimilar entry.
• Regulatory hurdles for new indications which could delay revenue growth.

Financial Trajectory Summary

Year	Revenue Estimate	Growth Driver
2023	USD 800 million	Greater prescriber confidence, expanded reimbursement
2024	USD 900 million	Integration into clinical guidelines
2025	USD 1 billion	Broader indications, increasing off-label use
2028	USD 1.5 billion	Peak growth before patent expiry begins
2030	USD 2+ billion	Market expansion into other BRCA-mutated cancers

Key Takeaways

• Niraparib tosylate remains a leading PARP inhibitor in ovarian cancer, with notable market share in the U.S.
• The drug’s revenue growth is driven by expanded indications, clinical trial success, and evolving treatment protocols.
• Long-term prospects depend on new approvals, pipeline developments, and competitive dynamics.
• Potential patent expiry around 2028-2030 presents revenue risk.
• Market penetration in Europe and Asia is increasing but remains below U.S. levels.

FAQs

1. What are the main competitors to Niraparib?
Olaparib and Rucaparib are the primary competitors, holding larger shares in some markets but with similar indications.

2. How does the patent expiration affect revenue?
Patent expiry around 2028-2030 is expected to lead to biosimilar entry, reducing prices and revenues.

3. What new indications are in development?
Research includes first-line maintenance therapy, combination with immunotherapies, and applications in prostate and breast cancers.

4. How does reimbursement influence sales?
Coverage in major markets like the U.S. and Europe facilitates high prescription rates, boosting sales.

5. What are the key risks for Niraparib’s financial future?
Patent expiration, biosimilar competition, regulatory delays, and pricing pressures pose risks.

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References

[1] MarketsandMarkets. (2022). PARP inhibitors market report.

[2] FDA. (2020). Approval of Niraparib for ovarian cancer maintenance.

[3] EvaluatePharma. (2022). Oncology drug sales analysis.

[4] GSK official filings. (2021). Quarterly financial reports.