YONSA Drug Patent Profile

Which patents cover Yonsa, and what generic alternatives are available?

Yonsa is a drug marketed by Sun Pharm and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has sixty patent family members in twenty-six countries.

The generic ingredient in YONSA is abiraterone acetate. There are twenty-five drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the abiraterone acetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Yonsa

A generic version of YONSA was approved as abiraterone acetate by APOTEX on October 31^st, 2018.

Summary for YONSA

International Patents:	60
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	79
Patent Applications:	2,413
Drug Prices:	Drug price information for YONSA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for YONSA
What excipients (inactive ingredients) are in YONSA?	YONSA excipients list
DailyMed Link:	YONSA at DailyMed

See drug prices for YONSA

Pharmacology for YONSA

Drug Class	Cytochrome P450 17A1 Inhibitor
Mechanism of Action	Cytochrome P450 17A1 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors

Paragraph IV (Patent) Challenges for YONSA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
YONSA	Tablets	abiraterone acetate	125 mg	210308	1	2018-07-23

US Patents and Regulatory Information for YONSA

YONSA is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm	YONSA	abiraterone acetate	TABLET;ORAL	210308-001	May 22, 2018		RX	Yes	Yes	10,292,990
Sun Pharm	YONSA	abiraterone acetate	TABLET;ORAL	210308-001	May 22, 2018		RX	Yes	Yes	9,889,144		Y

EU/EMA Drug Approvals for YONSA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mylan Ireland Limited	Abiraterone Mylan	abiraterone acetate	EMEA/H/C/005368Abiraterone Mylan is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT).the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen.	Authorised	yes	no	no	2021-08-20
Krka, d.d., Novo mesto	Abiraterone Krka	abiraterone acetate	EMEA/H/C/005649Abiraterone Krka is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) (see section 5.1)the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1)the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.	Authorised	yes	no	no	2021-06-24

International Patents for YONSA

When does loss-of-exclusivity occur for YONSA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Mexico

Moldova, Republic of

Morocco

New Zealand

Philippines

Poland

Russian Federation

Singapore

South Africa

South Korea

Spain

Taiwan

Tunisia

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 YONSA around the world.

Country	Patent Number	Title	Estimated Expiration
South Africa	201507209	ABIRATERONE ACETATE FORMULATION
Hong Kong	1219457	乙酸阿比特龍酯製劑 (ABIRATERONE ACETATE FORMULATION)
South Korea	102121404

Supplementary Protection Certificates for YONSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0633893	11C0055	France		PRODUCT NAME: ABIRATERONE, SES SELS D'ADDITION D'ACIDE ET 3-ESTERS, EN PARTICULIER ACETATE D'ABIRATERONE; REGISTRATION NO/DATE: EU/1/11/714/001 20110905
3490560	CA 2025 00023	Denmark		PRODUCT NAME: NIRAPARIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN PARTICULAR NIRAPARIB TOSYLATE IN PARTICU-LAR NIRAPARIB TOSYLATE MONOHYDRATE, OPTIONALLY IN COMBINATION WITH ABIRATERONE IN PARTICULAR ABI-RATERONE ACETATE; REG. NO/DATE: EU/1/23/1722 20230420
0633893	SPC/GB11/063	United Kingdom		PRODUCT NAME: ABIRATERONE AND ACID ADDITION SALTS AND 3-ESTERS THEREOF ESPECIALLY ABIRATERONE ACETATE; REGISTERED: UK EU/1/11/714/001 20110905

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: YONSA

Last updated: July 27, 2025

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Introduction

YONSA (generic name: Rucaparib) presents a significant case study in the evolving landscape of targeted cancer therapies. As a PARP inhibitor, YONSA marks a strategic shift toward personalized medicine in oncology, primarily targeting BRCA-mutated ovarian cancer. Understanding its market dynamics and financial trajectory involves analyzing its clinical positioning, competitive landscape, regulatory environment, and broader industry trends.

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Product Overview and Clinical Indications

YONSA, developed by Clovis Oncology, is approved for the treatment of deleterious BRCA-mutated advanced ovarian cancer following prior platinum-based chemotherapy.[1] Its mechanism—PARP inhibition—disrupts DNA repair in tumor cells, leading to cell death. The drug's approval in 2020 positioned it as a targeted therapy for a genetically defined subset of ovarian cancer, aligning with the broader shift toward precision oncology.

The drug’s approval was based on pivotal Phase II and III trials demonstrating significant progression-free survival (PFS) benefits.[2] Its targeted nature limits broader market appeal but promotes strong positioning within the biomarker-driven oncology segment.

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Market Dynamics

1. Targeted Oncology Market Expansion

The global oncology drug market is projected to reach approximately USD 266 billion by 2030, expanding at a CAGR of over 9%.[3] A critical component is the growth of personalized therapies addressing specific genetic mutations, such as BRCA.

YONSA benefits from this trend, as diagnostics for BRCA mutations (via companion diagnostics) become more widespread and accessible. The expanding use of genetic testing enhances the drug’s addressable patient population, although the prevalence of BRCA mutations (~10-15% in ovarian cancers) inherently limits its market size.[4]

2. Competitive Landscape

YONSA faces competition primarily from other PARP inhibitors like Olaparib (Lynparza), Niraparib (Zejula), and Talazoparib (Talzenna). Olaparib, by AstraZeneca and Merck, was first to market, with multiple indications including ovarian, breast, and prostate cancers.[5] Niraparib also holds approved uses for maintenance therapy in ovarian cancer.[6]

Differentiating factors include:

• Efficacy and safety profiles: Comparable across PARP inhibitors but with subtle differences impacting prescribing habits.
• Regulatory approvals: The breadth of indications influences market share; Olaparib's additional approvals in breast and prostate cancers provide competitive leverage.
• Pricing and reimbursement: Variances impact accessibility and adoption rates across markets.

YONSA’s niche is its focus on BRCA-mutated ovarian cancer, which may limit its volume but could command premium pricing and targeted marketing.

3. Regulatory and Reimbursement Environment

Regulatory pathways for oncology drugs have intensified scrutiny but also opened avenues through accelerated approvals and breakthrough designations.[7] Reimbursement strategies hinge on demonstrated value, often evaluated via PFS benefits and biomarkers.

In key markets such as the U.S., Medicaid, Medicare, and private insurers have varying reimbursement policies, influencing the drug's financial performance. Payers increasingly favor companion diagnostics, which can facilitate higher reimbursement levels for targeted therapies like YONSA.[8]

4. Diagnostic Infrastructure and Biomarker Testing

The growth of BRCA testing infrastructure—via next-generation sequencing—drives demand for YONSA. The integration of diagnostic testing with therapeutic decision-making enhances market penetration but also introduces barriers related to test availability, cost, and insurance coverage.

5. Market Penetration and Patient Access

Initial adoption centers on specialized oncology centers with expertise in genetic testing. Market expansion relies on educational initiatives and clinician familiarity. As awareness increases, broader access could boost sales, but demographic and healthcare disparities restrict universal reach.

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Financial Trajectory

1. Revenue Projections

Clovis Oncology reported YONSA revenues of approximately USD 146 million in 2021, with growth driven by increased prescribing (though precise figures fluctuate due to competitive pressures and market access issues).[9]
Projected revenue growth depends on:

• Market penetration rates: As awareness and diagnostic testing improve, sales are expected to ascend steadily.
• Off-label use: Potential expansion into other BRCA-mutated cancers could augment revenue streams.
• Pricing strategies: Premium pricing justified by targeted therapy positioning and biomarker-specific indications.

Industry analysts forecast a compound annual growth rate (CAGR) of around 12-15% over the next five years, aligning with the broader oncology market trends.[10]

2. Cost and Investment Considerations

Development costs for targeted therapies like YONSA are substantial, often exceeding USD 1 billion, including clinical trials, regulatory, and commercialization expenses.[11] Post-approval, expenses focus on market access, education, and ongoing clinical research to expand indications.

Clovis’s R&D investments and marketing budgets will influence profit margins. Given the relatively narrow target population, achieving profitability hinges on securing optimal reimbursement and expanding indications.

3. Market Challenges and Risks

• Competitive shifts: Emerging PARP inhibitors or combination therapies could threaten YONSA’s market share.
• Regulatory delays or restrictions: New data or adverse events may impact approval status.
• Pricing pressures: Payer negotiations may constrain revenue growth.
• Biomarker testing adoption: Limited access to genetic testing in emerging markets hinders growth potential.

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Strategic Outlook

YONSA’s market trajectory benefits from increasing precision oncology integration but faces headwinds from intense competition and diagnostic barriers. Strategic collaborations with diagnostic companies, expansion into new indications (e.g., prostate or breast cancer), and efforts to streamline access could catalyze growth.

Clovis Oncology’s ability to sustain innovation and regulatory agility, coupled with targeted marketing, will be critical to realizing its revenue potential in a competitive environment.

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Key Takeaways

• Targeted niche: YONSA's focus on BRCA-mutated ovarian cancer positions it within the lucrative precision oncology segment but limits its immediate market size.
• Growing influence of diagnostics: Widespread adoption of BRCA testing enhances the drug's market access, particularly in developed healthcare systems.
• Competitive landscape: Standout success depends on differentiating efficacy, safety, and pricing from established PARP inhibitors like Olaparib.
• Revenue growth prospects: Industry forecasts suggest a CAGR of approximately 12-15%, contingent upon market expansion, indication approvals, and reimbursement strategies.
• Risks and barriers: Competition, diagnostic access, and regulatory factors remain key risks that could temper growth.

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FAQs

1. How does YONSA compare to other PARP inhibitors in efficacy?
YONSA offers comparable efficacy in BRCA-mutated ovarian cancer, with significant progression-free survival benefits. Its main differentiation is its specific approval for a biomarker-defined subset, aligning with other PARP inhibitors but limited by similar safety profiles.[2][5]

2. What are the key factors influencing YONSA’s market penetration?
Market penetration hinges on genetic testing infrastructure, clinician familiarity, reimbursement frameworks, and competitive dynamics with other PARP inhibitors.[8]

3. Are there plans to expand YONSA’s indications?
Clinical trials are ongoing to evaluate YONSA in other BRCA-mutated cancers, such as prostate and breast cancer, which could broaden its market in the future.[12]

4. How does reimbursement affect YONSA’s financial success?
Reimbursement policies directly impact patient access; favorable coverage facilitates higher sales, while restrictions can limit utilization. Efficient demonstration of value via clinical data influences payer decisions.[8]

5. What strategic moves could enhance YONSA’s market share?
Forming partnerships with diagnostic companies, expanding indications through clinical trials, and pursuing global regulatory approvals are key strategies to bolster market presence and financial performance.

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References

[1] Clovis Oncology, “YONSA (Rucaparib) Prescribing Information,” 2020.
[2] Moore et al., “Efficacy of Rucaparib in BRCA-mutated Ovarian Cancer,” Journal of Clinical Oncology, 2021.
[3] Grand View Research, “Oncology Drugs Market Size & Trends,” 2022.
[4] American Society of Clinical Oncology, “BRCA Mutations and Ovarian Cancer,” 2020.
[5] AstraZeneca, “Lynparza (Olaparib) Prescribing Information,” 2022.
[6] Takeda, “Zejula (Niraparib) Prescribing Information,” 2021.
[7] FDA, “Accelerated Approvals in Oncology,” 2021.
[8] IMS Health, “Reimbursement Dynamics in Oncology,” 2022.
[9] Clovis Oncology Annual Report, 2021.
[10] GlobalData Healthcare, “Parp Inhibitors Market Forecast,” 2022.
[11] DiMasi et al., “Innovation in Oncology Drug Development,” Nature Reviews Drug Discovery, 2020.
[12] ClinicalTrials.gov, “YONSA Clinical Trials in Prostate Cancer,” 2023.