ABIRATERONE ACETATE - Generic Drug Details

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

Abiraterone acetate is the generic ingredient in four branded drugs marketed by Amneal Pharms, Apotex, Dr Reddys, Glenmark Speclt, Hikma, MSN, Mylan, Novugen, Qilu, Regcon Holdings, Rising, Teva Pharms Usa, Wockhardt Bio Ag, Sun Pharm, and Janssen Biotech, and is included in eighteen NDAs. There are fourteen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Abiraterone acetate has sixty patent family members in twenty-six countries.

There are twenty-two drug master file entries for abiraterone acetate. Twenty-three suppliers are listed for this compound.

Summary for ABIRATERONE ACETATE

International Patents:	60
US Patents:	14
Tradenames:	4
Applicants:	15
NDAs:	18
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	279
Patent Applications:	5,684
Drug Prices:	Drug price trends for ABIRATERONE ACETATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ABIRATERONE ACETATE
What excipients (inactive ingredients) are in ABIRATERONE ACETATE?	ABIRATERONE ACETATE excipients list
DailyMed Link:	ABIRATERONE ACETATE at DailyMed

See drug prices for ABIRATERONE ACETATE

Recent Clinical Trials for ABIRATERONE ACETATE

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

Sponsor	Phase
Amgen	PHASE3
Janssen, LP	PHASE2
Qilu Pharmaceutical Co., Ltd.	PHASE1

See all ABIRATERONE ACETATE clinical trials

Pharmacology for ABIRATERONE ACETATE

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

Medical Subject Heading (MeSH) Categories for ABIRATERONE ACETATE

Antineoplastic Agents

Cytochrome P-450 Enzyme Inhibitors

Steroid Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ABIRATERONE ACETATE

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

Paragraph IV (Patent) Challenges for ABIRATERONE ACETATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
YONSA	Tablets	abiraterone acetate	125 mg	210308	1	2018-07-23
ZYTIGA	Tablets	abiraterone acetate	500 mg	202379	1	2017-08-23
ZYTIGA	Tablets	abiraterone acetate	250 mg	202379	13	2015-04-28

US Patents and Regulatory Information for ABIRATERONE ACETATE

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	11,091,459		Y	Y
Glenmark Speclt	ABIRATERONE ACETATE	abiraterone acetate	TABLET;ORAL	209227-001	Oct 16, 2019	AB	RX	No	No
Sun Pharm	YONSA	abiraterone acetate	TABLET;ORAL	210308-001	May 22, 2018		RX	Yes	Yes	10,292,990
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-002	Aug 11, 2023		RX	Yes	Yes	8,859,562

Expired US Patents for ABIRATERONE ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Biotech	ZYTIGA	abiraterone acetate	TABLET;ORAL	202379-001	Apr 28, 2011	5,604,213

EU/EMA Drug Approvals for ABIRATERONE ACETATE

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 ABIRATERONE ACETATE

Country	Patent Number	Title	Estimated Expiration
Taiwan	I731321
Morocco	40116	Formulation d'acétate d'abiratérone et ses procédés d'utilisation
Australia	2018241103
Japan	2018135351	アビラテロン酢酸エステル製剤 (ABIRATERONE ACETATE FORMULATION)

Supplementary Protection Certificates for ABIRATERONE ACETATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0633893	2012/003	Ireland		PRODUCT NAME: ZYTIGA (ABIRATERONE) "ABIRATERONE AND ACID ADDITION SALTS AND 3-ESTERS THEREOF, ESPECIALLY ABIRATERONE ACETATE"; REGISTRATION NO/DATE: EU/1/11/714/001 20110905
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

Market Dynamics and Financial Trajectory for Abiraterone Acetate

Last updated: October 30, 2025

Introduction

Abiraterone acetate, a pioneering androgen biosynthesis inhibitor developed by Janssen Pharmaceuticals and approved by the U.S. Food and Drug Administration (FDA) in 2011, has revolutionized the treatment landscape for metastatic castration-resistant prostate cancer (mCRPC). As a critical component in prostate cancer management, its market trajectory is influenced by evolving clinical data, regulatory landscape, competitive dynamics, and healthcare policy shifts. This analysis explores the current market forces shaping abiraterone acetate’s commercial outlook and projects its financial trajectory over the coming years.

Market Overview

The global prostate cancer therapeutics market is projected to reach USD 8.2 billion by 2027, growing at a compound annual growth rate (CAGR) of approximately 7% (Research and Markets, 2022). Abiraterone acetate holds a significant share within this segment, owing to its first-in-class status and proven efficacy. Its primary indications include mCRPC post-chemotherapy and, more recently, metastatic castration-sensitive prostate cancer (mCSPC).

The drug’s commercial success hinges on factors such as treatment paradigm shifts, pricing strategies, and patent protections. According to IQVIA data, the U.S. accounted for roughly 60% of sales in 2022, reflecting high adoption rates driven by clinical guidelines and reimbursement frameworks.

Market Drivers

1. Increasing Incidence of Prostate Cancer
   Prostate cancer is the second most common cancer among men worldwide. The Global Burden of Disease Study estimates a 2% annual increase in new cases globally, largely attributable to aging populations and improved detection. Higher prevalence directly correlates with sustained demand for effective treatments like abiraterone acetate.

2. Therapeutic Advancements and Combination Regimens
   Approved in combination with prednisone, abiraterone acetate demonstrated a survival benefit in mCRPC and mCSPC settings. Emerging data support its integration into early treatment regimens, expanding its market footprint.

3. Evolving Clinical Guidelines
   Major guidelines, including those from NCCN and ESMO, now favor abiraterone as a first-line or solid second-line therapy for advanced prostate cancer, further cementing its role and encouraging broader uptake.

4. Patent Protection and Biosimilars
   Patent protections, valid until at least 2027, limit generic competition. However, the imminent expiration portends potential market erosion and the advent of biosimilars, which could influence pricing and sales volumes.

5. Reimbursement and Pricing Dynamics
   Favorable reimbursement policies in major markets bolster access, though cost-containment measures and value-based pricing pressures increasingly influence sales.

Market Challenges

• Generic Competition Post-Patent Expiry
  Expected patent cliff around 2027 in the U.S. and Europe threatens to open the market to biosimilars and generics, exerting downward pressure on prices.

• Pricing Pressures and Cost-Containment
  Governments and insurers seek to limit drug expenditure, compelling pharmaceutical companies to justify pricing through demonstrated value and real-world outcomes.

• Clinical and Regulatory Developments
  The ongoing evolution of prostate cancer treatments, including novel androgen receptor antagonists and chemotherapies, could diminish abiraterone’s relative attractiveness or curtail its market share.

Financial Trajectory

Historical Performance
Since its launch, abiraterone acetate has achieved robust sales, peaking at approximately USD 2.5 billion globally in 2021 (IQVIA). The drug has maintained dominant market share through consistent clinical uptake and extensive formulary positioning.

Short to Medium-Term Outlook (2023–2027)
Projected sales are expected to plateau owing to increased competition, particularly from next-generation androgen receptor inhibitors such as enzalutamide and apalutamide. Nonetheless, continued adoption in early-line settings and expanding indications in high-income markets will sustain revenues. Analysts forecast a CAGR of around 4% during this period, with potential for temporary accelerations driven by guideline updates and real-world evidence publications.

Long-Term Outlook (Post-2027)
Following patent expiration, sales could decline sharply unless offset by biosimilar availability, global market expansion, or new indications. The introduction of cost-effective biosimilars could reduce costs and expand market penetration, but may also compress profit margins.

Strategic Considerations

• Investment in Biosimilar Development
  Companies investing early can capitalize on looming patent cliffs, but navigating regulatory pathways and establishing market acceptance remain critical.

• Differentiation and Value-Added Strategies
  Clinical trials demonstrating superior efficacy or safety, coupled with digital health integration, can reinforce brand loyalty and sustain pricing power.

• Geographic Expansion
  Growing markets like Asia-Pacific and Latin America could buffer declines in mature markets, especially where prostate cancer incidence is rising and healthcare access improving.

Conclusion

Abiraterone acetate’s market dynamics are fundamentally driven by clinical efficacy, regulatory landscape, competitive pressures, and healthcare economics. Although its current financial trajectory suggests robust stability over the next five years, impending patent expiry and evolving treatment paradigms pose significant challenges. Companies must adopt strategic innovation and geographic diversification to optimize long-term profitability.

Key Takeaways

• Abiraterone acetate remains a cornerstone in prostate cancer therapy, supported by strong clinical evidence and guideline endorsement.
• Patent protection and reimbursement policies are primary drivers of current market stability, but impending patent expiry in 2027 will introduce biosimilar competition.
• The market growth is driven by rising prostate cancer incidence, expanding indications, and evolving treatment standards favoring early and combination therapies.
• Post-patent landscape will require strategic adaptation, including biosimilar development and geographic market expansion.
• For investors and stakeholders, monitoring regulatory developments, clinical trial outcomes, and market entry of biosimilars is essential for informed decision-making.

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FAQs

1. What factors could accelerate or delay the patent expiry of abiraterone acetate?
   Patent expiry may be influenced by legal challenges, patent term extensions, or secondary patents. Any successful patent infringement disputes or new formulations could delay expiry, while legal or regulatory hurdles might accelerate it.

2. How does abiraterone acetate compare financially to its competitors?
   While abiraterone has maintained a leading market share, competitors such as enzalutamide and apalutamide offer similar efficacy profiles and may influence pricing and sales volumes, especially once biosimilars enter the market.

3. What are the potential new indications that could extend abiraterone’s market viability?
   Ongoing clinical trials are exploring abiraterone’s efficacy in earlier prostate cancer stages and combination regimens, which could expand its label indications and prolong its revenue-generating potential.

4. How will biosimilar competition affect abiraterone’s pricing and market share?
   Biosimilar entry generally results in significant price reductions, potentially eroding margins and reducing market share unless the originator maintains competitive advantages through brand recognition and evidence of superior outcomes.

5. What strategies should pharmaceutical companies pursue to maximize profits post-patent?
   Developing and deploying biosimilars, expanding into emerging markets, innovating with new formulations or delivery methods, and engaging in partnerships for combination therapies are key strategies.

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References

[1] Research and Markets. “Prostate Cancer Therapeutics Market—Growth, Trends, and Forecasts (2022-2027).”
[2] IQVIA. “Pharmaceutical Market Analysis Data, 2022.”
[3] National Comprehensive Cancer Network (NCCN) Guidelines.
[4] European Society for Medical Oncology (ESMO) Clinical Practice Guidelines.