ABIRATERONE ACETATE; NIRAPARIB TOSYLATE - Generic Drug Details

What are the generic drug sources for abiraterone acetate; niraparib tosylate and what is the scope of freedom to operate?

Abiraterone acetate; niraparib tosylate is the generic ingredient in one branded drug marketed by Janssen Biotech and is included in one NDA. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Abiraterone acetate; niraparib tosylate has three hundred and eleven patent family members in fifty-seven countries.

One supplier is listed for this compound.

Summary for ABIRATERONE ACETATE; NIRAPARIB TOSYLATE

International Patents:	311
US Patents:	12
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ABIRATERONE ACETATE; NIRAPARIB TOSYLATE
DailyMed Link:	ABIRATERONE ACETATE; NIRAPARIB TOSYLATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ABIRATERONE ACETATE; NIRAPARIB TOSYLATE

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.

Pharmacology for ABIRATERONE ACETATE; NIRAPARIB TOSYLATE

Drug Class	Cytochrome P450 17A1 Inhibitor Poly(ADP-Ribose) Polymerase Inhibitor
Mechanism of Action	Cytochrome P450 17A1 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors Poly(ADP-Ribose) Polymerase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ABIRATERONE ACETATE; NIRAPARIB TOSYLATE

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

L02BX	Other hormone antagonists and related agents
L02B	HORMONE ANTAGONISTS AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for ABIRATERONE ACETATE; NIRAPARIB TOSYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-002	Aug 11, 2023		RX	Yes	Yes
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-002	Aug 11, 2023		RX	Yes	Yes
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-001	Aug 11, 2023		RX	Yes	No			Y	Y
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-001	Aug 11, 2023		RX	Yes	No

International Patents for ABIRATERONE ACETATE; NIRAPARIB TOSYLATE

Country	Patent Number	Title	Estimated Expiration
New Zealand	586675
Lithuania	C2109608
Hungary	S2500030
Luxembourg	92680

Supplementary Protection Certificates for ABIRATERONE ACETATE; NIRAPARIB TOSYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2240466	2018/020	Ireland		PRODUCT NAME: NIRAPARIB TOSYLATE OR A HYDRATE THEREOF, ESPECIALLY THE TOSYLATE MONOHYDRATE; REGISTRATION NO/DATE: EU/1/17/1235 20171116
2109608	2018/019	Ireland		PRODUCT NAME: NIRAPARIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, STEREOISOMER OR TAUTOMER THEREOF, PARTICULARLY THE TOSYLATE OR A HYDRATE, ESPECIALLY THE TOSYLATE MONOHYDRATE.; REGISTRATION NO/DATE: EU/1/17/1235 20171116
2109608	CA 2018 00017	Denmark		PRODUCT NAME: NIRAPARIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, STEREOISOMER OR TAUTOMER THEREOF, PARTICULARLY THE; REG. NO/DATE: EU/1/17/1235 20171120
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

Market Dynamics and Financial Trajectory for Abiraterone Acetate and Niraparib Tosylate

Last updated: July 28, 2025

Introduction

The pharmaceuticals landscape consistently evolves, driven by technological innovation, regulatory changes, and shifting patient demographics. Among current therapeutics, Abiraterone Acetate and Niraparib Tosylate have garnered notable attention, primarily within oncology indications — prostate cancer and ovarian cancer, respectively. Their market trajectories, underpinned by scientific advancements, competitive positioning, and reimbursement landscapes, are critical for stakeholders aiming to capitalize on growth opportunities.

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Market Overview of Abiraterone Acetate

Therapeutic Profile and Indications

Abiraterone Acetate, marketed as Zytiga, is a steroidal anti-androgen therapy developed for metastatic castration-resistant prostate cancer (mCRPC). It functions by inhibiting CYP17A1, a key enzyme in androgen biosynthesis, thereby reducing tumor-promoting androgen levels (1). Originally approved by the FDA in 2011, its primary approved indications incluede mCRPC post-chemotherapy and long-term hormone treatment.

Market Size and Growth Dynamics

Global sales of Abiraterone Acetate approached $3.4 billion in 2022, with North America accounting for over 60% of sales, reflective of high adoption rates and reimbursement support (2). The compound's market grew at a compound annual growth rate (CAGR) of approximately 12% from 2017–2022, driven by expanding indications, such as early-line treatment in combination with androgen deprivation therapy (ADT), and increasing prostate cancer prevalence in aging male populations.

Competitive Landscape

Abiraterone faces competition from novel androgen receptor signaling inhibitors like enzalutamide and apalutamide, which are also approved for similar indications. Additionally, emerging therapies targeting prostate cancer are in development, but Abiraterone's established efficacy and broad insurance coverage sustain its market relevance. Patent expiry scheduled for late 2020s has prompted entry of biosimilars and generics, exerting pricing pressures.

Regulatory and Reimbursement Trends

Recent regulatory approvals in emerging markets and expanded indications underpin revenue growth prospects. However, reimbursement policies, especially in cost-controlled healthcare systems, influence prescribing behavior. Patents and exclusivity periods significantly impact short-term revenue potential.

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Market Overview of Niraparib Tosylate

Therapeutic Profile and Indications

Niraparib Tosylate, marketed as Zejula, is an oral PARP inhibitor approved for maintenance treatment of recurrent ovarian, fallopian tube, or primary peritoneal cancer, particularly in patients responding to platinum-based chemotherapy (3). Its mechanism targets poly(ADP-ribose) polymerase enzymes, exploiting DNA repair pathway vulnerabilities, particularly in BRCA-mutated tumors.

Market Size and Growth Dynamics

The global ovarian cancer therapeutics market, with Niraparib as a leading agent, was valued at approximately $2.8 billion in 2022. The PARP inhibitor segment dominates owing to high efficacy profiles and expanding indications. Niraparib sales are projected to grow at a CAGR of 14% through 2028, driven by approvals for first-line maintenance therapy, expanding BRCA testing, and biomarker-driven patient selection (4).

Competitive Landscape

Niraparib contends with other PARP inhibitors such as Olaparib and Rucaparib, each with comparable efficacy profiles. Differentiation hinges on dosing convenience, side effect profiles, and patient-specific biomarker strategies. Recently, the approval for first-line maintenance has broadened its market reach, intensifying competition.

Regulatory and Reimbursement Trends

Regulatory agencies have increasingly favored companion diagnostics, fostering personalized approaches. Reimbursement policies are evolving with health technology assessments, influencing prescribing practices. The high cost of PARP inhibitors has prompted discussions around cost-effectiveness, impacting market penetration.

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Financial Trajectory and Investment Outlook

Revenue Trends

Both drugs exhibit strong revenue trajectories, with Abiraterone solidifying its position in prostate cancer and Niraparib expanding its footprint in ovarian cancer. The influence of patent expiries, biosimilar development, and new indications will shape future income streams.

Pipeline and Innovation

Next-generation formulations—such as extended-release versions of Niraparib—aim to improve patient compliance and reduce side effects. Combination therapies with immunotherapy agents present lucrative avenues, potentially doubling market sizes and extending product life cycles.

Emerging Market Opportunities

Expanding access in Asia-Pacific and Latin America offers significant upside, driven by increasing cancer incidence and healthcare infrastructure development. Strategic partnerships with local manufacturers and those focused on biosimilars are vital.

Risks and Challenges

Intellectual property challenges, generic entry, and competitive innovation threaten margins. Regulatory delays, reimbursement hurdles, and safety concerns (particularly hematological adverse effects for PARP inhibitors) may impede growth.

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Strategic Implications

Investors and pharmaceutical companies should focus on pipeline expansion, biomarker integration, and geographic penetration. Collaborations with diagnostic firms can enhance market access, especially for Niraparib, where biomarker-driven patient selection is pivotal.

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Key Takeaways

• Robust Growth Prospects: Both Abiraterone Acetate and Niraparib Tosylate are on trajectory for sustained growth, propelled by expanding indications and surgical targeting of biomarkers.

• Competitive Landscape Navigation: Market share will increasingly depend on differentiation via safety profiles, dosing convenience, and combination regimens, requiring ongoing R&D investment.

• Regulatory and Reimbursement Strategies: Navigating evolving policies remains critical. Early engagement with regulators and payers can optimize market access and revenue stability.

• Pipeline and Innovation: Advancing formulations and combination therapies will fortify competitive positioning and address resistance mechanisms.

• Emerging Markets Expansion: Growth in emerging economies offers significant potential; however, adapting to local regulatory and reimbursement environments is key.

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FAQs

1. What factors influence the market penetration of Abiraterone Acetate?
Market penetration depends on clinical guideline adoption, patent status, pricing strategies, and competing therapies. Also, expanding indications, especially in earlier treatment lines, boost adoption.

2. How does Niraparib differentiate itself from other PARP inhibitors?
Niraparib’s once-daily dosing, approval for maintenance therapy regardless of BRCA mutation status, and biomarker-driven indications distinguish it from competitors.

3. What impact do biosimilars have on Abiraterone and Niraparib markets?
Biosimilars and generics are poised to reduce drug prices, intensify pricing pressures, and potentially erode revenue streams once patents expire, emphasizing the importance of innovation.

4. Which emerging markets present the most growth opportunities for these drugs?
China, India, and Brazil demonstrate substantial growth potential due to increasing cancer incidence, expanding healthcare access, and growing awareness.

5. What role will combination therapies play in the future of these drugs?
Combining Abiraterone and Niraparib with immunotherapies or targeted agents aims to improve efficacy, overcome resistance, and extend product lifecycle.

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References

[1] Smith, M. et al. (2020). "Mechanisms of Action of Abiraterone in Prostate Cancer." Oncology Reports.
[2] IQVIA. (2022). "Global Oncology Market Reports."
[3] FDA. (2019). "Niraparib Approval Summary."
[4] MarketsandMarkets. (2022). "PARP Inhibitors Market Analysis."