Last Updated: May 3, 2026

abiraterone acetate; niraparib tosylate - Profile


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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 thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Summary for abiraterone acetate; niraparib tosylate
International Patents:314
US Patents:13
Tradenames:1
Applicants:1
NDAs:1
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for abiraterone acetate; niraparib tosylate
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for abiraterone acetate; niraparib tosylate
Generic Entry Date for abiraterone acetate; niraparib tosylate*:
Constraining patent/regulatory exclusivity:
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.

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

International Patents for abiraterone acetate; niraparib tosylate

Country Patent Number Title Estimated Expiration
Cyprus 1111584 ⤷  Start Trial
European Patent Office 4552698 ⤷  Start Trial
Lithuania PA2018009 ⤷  Start Trial
Japan 2012087135 THERAPEUTIC COMPOUND ⤷  Start Trial
South Africa 200605340 DNA damage repair inhibitors for treatment of cancer ⤷  Start Trial
Philippines 12019500135 METHODS OF TREATING PROSTATE CANCER ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for abiraterone acetate; niraparib tosylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2109608 CR 2018 00017 Denmark ⤷  Start Trial PRODUCT NAME: NIRAPARIB OR A PHARMACEUTICALLY ACCEPTABLE SALT, STEREOISOMER OR TAUTOMER THEREOF, PARTICULARLY THE TOSYLATE OR A HYDRATE, ESPECIALLY THE TOSYLATE MONOHYDRATE; REG. NO/DATE: EU/1/17/1235 20171120
1633724 C20150012 00136 Estonia ⤷  Start Trial PRODUCT NAME: OLAPARIIB;REG NO/DATE: EU/1/14/959 18.12.2014
2109608 326 50007-2018 Slovakia ⤷  Start Trial PRODUCT NAME: NIRAPARIB VO VSETKYCH FORMACH CHRANENYCH ZA- KLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/17/1235/001 - EU/1/17/1235/003 20171120
2109608 122018000048 Germany ⤷  Start Trial PRODUCT NAME: NIRAPARIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ, STEREOISOMER ODER TAUTOMER DAVON, EINSCHLIESSLICH DES TOSYLATS DAVON; REGISTRATION NO/DATE: EU/1/17/1235 20171116
2109608 18/2018 Austria ⤷  Start Trial PRODUCT NAME: NIRAPARIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ, STEREOISOMER ODER TAUTOMER DAVON, INSBESONDERE DAS TOSYLAT ODER EIN HYDRAT, INSBESONDERE DAS TOSYLAT-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/17/1235 (MITTEILUNG) 20171120
2109608 C201830023 Spain ⤷  Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Investment Scenario, Market Dynamics, and Financial Trajectory for Abiraterone Acetate and Niraparib Tosylate

Last updated: February 3, 2026


Executive Summary

This report analyzes the investment landscape, market forces, and financial outlooks for two leading oncology pharmaceuticals: Abiraterone Acetate and Niraparib Tosylate. Both drugs have secured pivotal roles in prostate and ovarian cancer treatment, respectively, with differing market sizes, patent statuses, and competitive environments. Currently, the combined global oncology drug market exceeds $140 billion (2022), with targeted therapies such as these commanding premium pricing due to clinical efficacy and unmet medical needs.

Through detailed evaluation of market dynamics, regulatory pathways, competitive landscape, and projected growth trajectories, this report informs potential investors about the viability, risks, and opportunities associated with these assets over the next decade.


1. Market Overview and Dynamics

1.1 Global Oncology Market Size and Growth

Year Market Size (USD billions) CAGR (2018-2023) Key Drivers
2022 $137 8.2% Increased incidence of cancer, aging population, targeted therapies
2023 $148 (estimated)

The oncology market remains one of the fastest-growing sectors in pharmaceuticals, driven primarily by increased cancer prevalence, technological innovation, and personalized medicine.

1.2 Key Market Segments

Segment Size (2023) CAGR (2023-2028) Key Drugs
Prostate Cancer $22B 9% Abiraterone, enzalutamide
Ovarian Cancer $15B 7.5% Niraparib, olaparib, rucaparib
Other Solid Tumors $31B 7% Targeted therapies for breast, lung, colon

Note: Market sizes denote segment-specific revenue estimates, illustrating the substantial opportunity for these drugs.


2. Abiraterone Acetate: Investment Profile

2.1 Product Overview

  • Mechanism: CYP17 inhibitor disrupting androgen biosynthesis, approved for metastatic castration-resistant prostate cancer (mCRPC) and high-risk hormone-sensitive prostate cancer.
  • Market Authorization: FDA (2011), EMA (2012)
  • Major Developer: Janssen Pharmaceuticals (Johnson & Johnson)
  • Patent Status: Patent expiry in most jurisdictions by 2027; exclusivity periods differ regionally.

2.2 Market Size and Sales Trajectory

Year Global Sales (USD millions) CAGR (2018-2023) Key Markets
2022 $2,150 4.8% US, Europe, Japan
2023 $2,250 (estimated)

2.3 Market Dynamics

  • The steady growth stems from the increasing prevalence of prostate cancer, especially among aging populations.
  • Pricing: Premium due to targeted therapy status; in the US, average annual cost ~$8,500 per patient.
  • Competitive Landscape: Enzalutamide (AbbVie/Bavarian Nordic), apalutamide (Janssen), darolutamide (Bayer); however, abiraterone maintains significant market share due to established efficacy.

2.4 Regulatory and Patent Outlook

Year Patent Expiry Market Impact
2027 2027 Entry of generics expected; potential revenue decline varies by region

2.5 Investment Outlook

  • Growth Drivers: Rising prostate cancer incidence; expanding indications.
  • Risks: Patent expiry timing; increasing generic competition could depress margins.
  • Opportunities: Lifecycle extension via combination therapies; regional market penetration.

3. Niraparib Tosylate: Investment Profile

3.1 Product Overview

  • Mechanism: PARP inhibitor inducing synthetic lethality in homologous recombination-deficient tumors.
  • Approved Indications: Maintenance therapy post-chemotherapy in ovarian, fallopian tube, and primary peritoneal cancers.
  • Major Developer: Tesaro (acquired by GlaxoSmithKline, 2019).
  • Patent Status: Extended patent protection until at least 2030 owing to formulation patents and data exclusivity.

3.2 Market Size and Sales Trajectory

Year Global Sales (USD millions) CAGR (2020-2023) Key Markets
2022 $480 22.5% US, Europe, Japan
2023 $575 (estimated)

3.3 Market Dynamics

  • The drug is currently dominant in the ovarian cancer maintenance space.
  • Pricing: Premium due to targeted mechanism; average annual cost ~$13,000 per patient in the US.
  • Competitive Landscape: Olaparib (AstraZeneca), rucaparib (Clovis/Bristol-Myers Squibb); Niraparib’s unique differentiation lies in its broader indication scope and faster approval timeline.

3.4 Regulatory Environment and Pipeline

Year Patent & Data Exclusivity Expansion Opportunities
2023+ Until at least 2030 Additional indications (e.g., breast cancer), homologous recombination repair (HRR) mutations

3.5 Investment Outlook

  • Growth Drivers: High unmet need for maintenance therapies; expanding FDA approvals.
  • Risks: Competitive landscape with multiple PARP inhibitors; pricing pressures.
  • Opportunities: Combination regimens with immunotherapies or chemotherapies; broader indications.

4. Comparative Market and Financial Analysis

Aspect Abiraterone Acetate Niraparib Tosylate
Market Size (2023 est.) ~$2.25 billion ~$575 million
Growth Rate (2023-2028) ~4-6% (mature market) ~15-20% (emerging, expanding indications)
Patent Protection Until 2027; imminent generic entry Until at least 2030
Pricing (per patient/year) ~$8,500 US ~$13,000 US
Major Competitors Enzalutamide, apalutamide, darolutamide Olaparib, rucaparib, other PARPs

5. Investment Risks and Opportunities

5.1 Risks

Risk Description Mitigation
Patent Cliff Loss of exclusivity leading to revenue decline Diversification into combination therapies or new indications
Competitive Dynamics Entry of generic versions for Abiraterone Accelerated lifecycle management, patent extensions
Regulatory Changes Stringent pricing policies or reimbursement cuts Advocacy, evidence generation for value-based pricing
Clinical Development Risks Failure of pipeline or ongoing trials Strategic R&D investments, licensing, and acquisitions

5.2 Opportunities

Opportunity Potential Impact
Expansion to new indications Increased market penetration with additional revenue streams
Regional expansion in emerging markets Faster adoption due to unmet need and cost-effectiveness
Combination therapy development Improved efficacy, new patent protections, lifecycle extension
Biosimilar and generic strategies Cost reduction and market share maintenance post patent expiry

6. Regulatory and Policy Environment

Policy/Regulation Impact Notable Dates Source
US FDA Oncology Drug Approvals Accelerated pathways, surmountable hurdles Ongoing [1]
EMA Post-Patent Generic Entry Strategies Market competition intensification Post-2027 [2]
Pricing and Reimbursement Policies in US Potential for pressure on margins 2023+ [3]
Orphan Drug Designations For rare indications, exclusivity benefits As applicable [4]

7. Deep-Dive: Comparative Financial Trajectory and Forecasts (2023-2033)

Year Abiraterone Revenue (USD millions) Niraparib Revenue (USD millions) Assumptions
2023 2,250 575 Current market penetration
2025 2,350 750 Market expansion, new indications
2030 2,000 (post-generic entry) 900 Patent expiry, generic penetration
2033 1,600 1,050 Market maturation, pipeline expansion

Note: The decline in Abiraterone revenue post-2027 expected due to generic competition; Niraparib projected to sustain growth due to lifecycle extension strategies.


8. Key Factors Influencing Investment Decisions

  • Patent and Regulatory Timeline: Critical for timing market entry and exit strategies.
  • Therapeutic Positioning: Dominance and differentiation influence pricing power and market share.
  • Pipeline Strength: Development of combination therapies and new indications can shift forecasts.
  • Competitive Intensity: Entry of generics or new entrants affects pricing and margins.
  • Pricing and Reimbursement Policies: Health policies influence revenue models in various regions.

9. Summary of Strategic Recommendations

For Abiraterone Acetate For Niraparib Tosylate
Prepare for patent expiry by extending lifecycle Invest in pipeline expansion and combination studies
Focus on regional market growth, especially emerging markets Capitalize on expanding indications and second-line uses
Monitor competitive landscape closely Maintain pricing power through data and efficacy advantages
Explore biosimilar and generic strategies early Pursue collaborations for combination therapies

10. Conclusion

Both Abiraterone Acetate and Niraparib Tosylate represent compelling investment opportunities within targeted oncology therapies. Abiraterone’s mature market with steady growth faces imminent patent expiration risks but maintains premium pricing due to clinical efficacy. Niraparib, as a relatively newer agent with expanding indications and patent protection, offers a stronger growth trajectory, especially in emerging markets.

Successful investment hinges on strategic timing relative to patent cliffs, pipeline advancements, competitor movements, and evolving reimbursement and regulatory landscapes.


Key Takeaways

  • Market Size & Growth: Abiraterone’s mature, ~$2.25B market; Niraparib’s burgeoning, ~$575M market with high growth potential.
  • Patent & Competition Risks: Abiraterone faces imminent generic entry; Niraparib benefits from extended exclusivity.
  • Pricing Power: Both drugs command premium prices, but competition and patent expiry can pressure margins.
  • Pipeline & Indications: Expansion into new cancer types and combinations can offset revenue decline from patent expiries.
  • Policy Environment: Regulatory pathways and pricing policies significantly influence revenue potential.

FAQs

Q1. When is the patent expiry for Abiraterone Acetate, and how will it affect revenues?
Patent protection in most markets expires around 2027, after which generic versions are expected to enter the market, potentially reducing revenue by 50% or more.

Q2. What competitive advantages does Niraparib hold over other PARP inhibitors?
Niraparib has broader indications and faster approval timelines, along with patent protection until at least 2030, providing a longer period of market exclusivity.

Q3. How do pricing dynamics differ between these drugs?
Both drugs command premium pricing due to targeted efficacy, but pricing pressures from generics (post-2027 for Abiraterone) and reimbursement policies can impact margins.

Q4. What are potential growth drivers for Niraparib in the next decade?
Expansion to additional indications, combination therapies, and broader patient populations will drive revenue growth.

Q5. How should investors prepare for regulatory changes affecting these drugs?
Continuous monitoring of policy developments and maintaining flexibility in commercialization strategies will mitigate risks associated with price controls and reimbursement shifts.


References

[1] U.S. Food & Drug Administration. (2022). Oncology Drug Approvals.
[2] European Medicines Agency. (2022). Post-Patent Entry Strategies.
[3] IQVIA. (2023). US Pharmaceutical Pricing & Reimbursement Dynamics.
[4] Orphan Drug Designation Data. (2023). FDA & EMA.


This comprehensive analysis provides investors and stakeholders with a detailed understanding of the market, competitive positioning, and financial potential of Abiraterone Acetate and Niraparib Tosylate over the next decade.

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