NIRAPARIB TOSYLATE - Generic Drug Details

What are the generic drug 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-four patent family members in fifty-five countries.

One supplier is listed for this compound.

Summary for NIRAPARIB TOSYLATE

International Patents:	284
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

Constraining patent/regulatory exclusivity:

11,091,459

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

11,091,459

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
Oregon Health and Science University	Phase 1
Eli Lilly and Company	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	8,143,241
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-001	Apr 26, 2023		RX	Yes	No	8,436,185			Y
Glaxosmithkline	ZEJULA	niraparib tosylate	TABLET;ORAL	214876-001	Apr 26, 2023		RX	Yes	No	11,730,725		Y

International Patents for NIRAPARIB TOSYLATE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2109608
Australia	2009203598
South Korea	20200014736

Supplementary Protection Certificates for NIRAPARIB TOSYLATE

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
2109608	PA2018009	Lithuania		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	122018000048	Germany		PRODUCT NAME: NIRAPARIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ, STEREOISOMER ODER TAUTOMER DAVON, EINSCHLIESSLICH DES TOSYLATS DAVON; REGISTRATION NO/DATE: EU/1/17/1235 20171116

Market Dynamics and Financial Trajectory for NIRAPARIB TOSYLATE

Last updated: July 29, 2025

---

Introduction

Niraparib Tosylate, marketed as Zejula by GlaxoSmithKline (GSK), represents a significant advancement in targeted cancer therapy, specifically within the portfolio of PARP inhibitors. Approved for the maintenance treatment of ovarian cancer, niraparib’s market trajectory is shaped by evolving clinical data, regulatory landscapes, competitive positioning, and broader oncology trends. This report analyzes the current market dynamics and offers a forecast of the drug's financial prospects.

---

Pharmacological Profile and Clinical Applications

Niraparib is a potent poly(ADP-ribose) polymerase (PARP) inhibitor designed to exploit tumor DNA repair deficiencies. Its primary indication is as a maintenance therapy in ovarian cancer patients following platinum-based chemotherapy, particularly in those with recurrent ovarian cancer possessing BRCA mutations or homologous recombination deficiency (HRD) [1].

The drug's widespread adoption in ovarian cancer has been propelled by its favorable safety profile and efficacy in extending progression-free survival (PFS). Expanded approvals for other cancers, such as seniorly indications in breast and prostate cancers, could diversify its revenue streams [2].

---

Market Dynamics

1. Competitive Landscape

Niraparib operates within the competitive PARP inhibitor class, alongside notable agents like olaparib (Lynparza) and rucaparib (Rubraca). Olaparib, with broader indications including ovarian, breast, pancreatic, and prostate cancers, enjoys substantial market share, supported by earlier approval and extensive clinical data. Rucaparib also has a notable presence in ovarian and prostate cancers.

However, niraparib’s distinct advantage lies in its once-daily dosing and tolerability profile, which can influence prescriber preferences. The differentiation might become more pronounced as comparative efficacy data emerge and as clinical trials expand indications. Importantly, regulatory authorities like the FDA and EMA continue to approve niraparib for new indications, fostering competitive momentum [3].

2. Regulatory Developments

Regulatory bodies recently approved niraparib for additional indications, including first-line maintenance therapy in advanced ovarian cancer regardless of BRCA mutation status, broadening the patient population. Such approvals alleviate dependence on genetically defined subgroups, thereby enlarging the target market.

Conversely, delays or rejections of new indications could dampen sales growth. Maintaining a robust clinical evidence pipeline supports regulatory confidence.

3. Market Penetration and Adoption Trends

The drug’s penetration is robust in North American and European markets, driven by established guidelines recommending PARP inhibitors as standard-of-care in platinum-sensitive ovarian cancer. Nonetheless, gaps in awareness and reimbursement hurdles in emerging markets can restrain growth. Health insurance coverage, especially in the U.S., significantly influences adoption rates.

Furthermore, the COVID-19 pandemic temporarily disrupted oncology treatment pathways, but recovery has been underway. Increasing familiarity and long-term outcome data will facilitate greater prescriber confidence.

4. Pricing, Reimbursement, and Market Access

Pricing strategies for niraparib are aligned with premium oncology therapies, with list prices in the U.S. exceeding $14,000 per month [4]. While high costs pose reimbursement challenges, payers have shown willingness to reimburse based on clinical benefits, particularly in Europe and North America.

Negotiation with payers and inclusion in widely accepted formularies are crucial for sustained sales growth.

---

Financial Trajectory and Revenue Forecasts

1. Current Revenue Landscape

GSK reports that niraparib generated approximately £950 million ($1.2 billion) in annual sales in 2022, marking it as a cornerstone of its oncology franchise [5]. The drug’s revenue is concentrated in regions with mature markets, notably North America and Europe.

2. Growth Drivers

• Expansion of Indications: Approval in first-line maintenance settings increases the eligible patient pool, potentially doubling current sales over the next 2–3 years.
• Geographical Expansion: Emerging markets, including Asia-Pacific, Africa, and Latin America, present significant growth opportunities contingent on affordability and regulatory approval.
• Clinical Trials: Ongoing phase 3 studies assessing niraparib in various cancers could unlock new indications, diversifying revenue streams.

3. Challenges and Risks

• Intense Competition: Olaparib and rucaparib’s established presence could limit niraparib's market share, particularly if head-to-head trials favor competitors.
• Market Saturation: As more patients receive initial PARP inhibitor therapy, subsequent lines of treatment may see limited growth potential.
• Pricing Pressures: Payers scrutinize high-cost therapies; reimbursement restrictions may cap revenue growth.

4. Financial Forecast (2023–2027)

Considering market expansion, ongoing clinical successes, and increased adoption, revenue growth is projected to average approximately 10–12% annually over the next five years. By 2027, revenues could approach £2 billion ($2.5 billion), underpinning GSK’s oncology revenue diversification. However, the trajectory is susceptible to regulatory, competitive, and market access variables.

---

Future Outlook and Strategic Considerations

The future of niraparib hinges on the progression of clinical research, regulatory approvals of expanded indications, and effective market access strategies. Collaboration with healthcare providers and payers for value-based pricing will be essential. Additionally, innovations in combination therapies, such as pairing niraparib with immunotherapies or anti-angiogenic agents, could foster new growth avenues.

GSK’s pipeline for novel PARP inhibitor formulations or next-generation molecules might also influence long-term valuation.

---

Key Takeaways

• Niraparib Tosylate remains a key player in the PARP inhibitor market, backed by its efficacy in ovarian cancer maintenance therapy.
• Market growth is driven by expanding indications, geographic expansion, and evolving clinical data.
• Intense competition from olaparib and rucaparib underscores the importance of clinical differentiation and strategic market access.
• Revenue forecasts indicate steady growth, potentially reaching £2 billion by 2027, with upside from clinical and market expansion.
• Challenges include pricing pressures, reimbursement hurdles, and emerging competition.

---

Frequently Asked Questions (FAQs)

Q1: How does niraparib’s efficacy compare to other PARP inhibitors?
Niraparib has demonstrated comparable efficacy to olaparib and rucaparib in extending progression-free survival in ovarian cancer maintenance. Its distinct pharmacokinetic profile and tolerability may influence clinical choices, but no conclusive superiority exists; decisions often depend on patient-specific factors.

Q2: What are the primary markets for niraparib?
The United States, European Union, and Japan constitute the primary markets, with substantial sales derived from established reimbursement pathways and clinical adoption. Emerging markets are slated for growth, contingent on regulatory and financial considerations.

Q3: What are the upcoming regulatory milestones for niraparib?
Further approvals in first-line settings and additional cancer indications are anticipated, depending on the progression of ongoing clinical trials and regulatory submissions.

Q4: How might biosimilars or generics affect niraparib’s market share?
Currently, no biosimilars or generics are available for niraparib, given its patented status. Patent expirations could potentially introduce generic competition within 8–10 years, impacting pricing and market share.

Q5: What strategic advantages does GSK have in marketing niraparib?
GSK’s established oncology sales infrastructure, clinical trial portfolio, and focused marketing strategies position it favorably. Collaborations with healthcare providers, payers, and patient advocacy groups further strengthen market access.

---

References

[1] GSK. (2021). Zejula (niraparib) prescribing information.
[2] European Medicines Agency. (2022). Approval details for niraparib.
[3] FDA. (2022). New indications for niraparib.
[4] Drug Pricing Report. (2023). Oncology drug pricing analysis.
[5] GSK Annual Report. (2022). Oncology franchise performance.