Abiraterone acetate - Generic Drug Details

What are the generic drug 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, Florida, Glenmark Speclt, Hikma, MSN, Mylan, Novugen, Qilu, 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-one 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:	61
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
UT Southwestern Comprehensive Cancer Center	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	ZYTIGA	abiraterone acetate	TABLET;ORAL	202379-002	Apr 14, 2017	AB	RX	Yes	Yes
Novugen	ABIRATERONE ACETATE	abiraterone acetate	TABLET;ORAL	215947-001	Jan 5, 2022	AB	RX	No	No
Rising	ABIRATERONE ACETATE	abiraterone acetate	TABLET;ORAL	208371-001	Feb 25, 2019	AB	RX	No	No
Amneal Pharms	ABIRATERONE ACETATE	abiraterone acetate	TABLET;ORAL	208327-001	Jan 7, 2019	AB	RX	No	No

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

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
South Korea	20230014878	아비라테론 아세테이트 제제 및 사용 방법 (ABIRATERONE ACETATE FORMULATION AND METHODS OF USE)
Singapore	10201709400V	ABIRATERONE ACETATE FORMULATION
Japan	2018135351	アビラテロン酢酸エステル製剤 (ABIRATERONE ACETATE FORMULATION)
Russian Federation	2015144285	СОСТАВ НА ОСНОВЕ АБИРАТЕРОНА АЦЕТАТА

Supplementary Protection Certificates for abiraterone acetate

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
3490560	LUC50015	Luxembourg		PRODUCT NAME: NIRAPARIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN PARTICULAR NIRAPARIB TOSYLATE IN PARTICULAR NIRAPARIB TOSYLATE MONOHYDRATE, OPTIONALLY IN COMBINATION WITH ABIRATERONE IN PARTICULAR ABIRATERONE ACETATE; AUTHORISATION NUMBER AND 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 Abiraterone Acetate

Last updated: February 20, 2026

Abiraterone acetate, marketed as Zytiga by Janssen Pharmaceuticals, is a steroidal anti-androgen used to treat metastatic castration-resistant prostate cancer (mCRPC). The drug has seen steady growth driven by clinical demand, expanding indications, and regulatory approvals. Key market trends include increased adoption, patent expirations impacting generic entry, and competitive dynamics from alternative therapies.

Market Size and Growth Drivers

Global Market Value: Estimated at $2.3 billion in 2022, with a compound annual growth rate (CAGR) of approximately 8% projected through 2028.

Primary Growth Drivers:

• Rising prostate cancer prevalence, especially in North America and Europe.
• Increased adoption in earlier stages of prostate cancer, including metastatic hormone-sensitive settings.
• Expanding approval for combination therapies and extended indications.

Key Market Segments

Segment	Description	Market Share (2022)	Growth Rate (2022-2028)
Monotherapy	Used as standalone for mCRPC	60%	7%
Combination Therapy	Combined with prednisone or other agents	40%	9%

Patent and Regulatory Landscape

Patent Status: The original patent expired in the U.S. in 2022, leading to entry by generic manufacturers. Similar expirations occurred in Europe and other markets between 2021-2023.

Regulatory Approvals:

• Approved by the FDA in 2011.
• Extended indications include treatment-naïve metastatic castration-sensitive prostate cancer (mCSPC) following approvals in 2020 and 2022.
• Market approvals in Japan (2014), Europe (2012), and Canada (2012).

Competitive Landscape

Major Players:

• Pfizer (Zytiga, generic versions post-patent expiry)
• Sun Pharmaceutical Industries (generic)
• Mylan (generic)
• Teva Pharmaceutical Industries (generic)

Alternative Therapies:

• Enzalutamide (Xtandi)
• Apalutamide (Erleada)
• Darolutamide (Nubeqa)

These agents challenge abiraterone acetate’s market share, especially as they offer oral administration and different side-effect profiles.

Financial Trends

Year	Revenue (USD millions)	YoY Growth	Key Events
2020	2,050	5%	Expanded indications, global approvals
2021	2,150	4.9%	Patent expiration in U.S.; generic entries
2022	2,300	7%	Increased adoption, new combination approvals

Post-patent expiration, generic competition has driven prices down and pressured branded revenue. Sales growth continues modestly if innovation or better combination strategies emerge.

Financial Trajectory Outlook

Short-term (2023-2025): Moderated growth due to generic competition, price erosion, and competition from newer agents. Expect stabilization around $2.2 billion annually.

Mid-term (2026-2028): Potential growth driven by expansion into early-stage prostate cancer and combination therapies. Possible revenue increase to approximately $2.8 billion if approval trends favor expanded use.

Key Risks and Opportunities

Risks:

• Patent expiry and resulting pricing pressure.
• Competition from newer agents with superior side-effect profiles.
• Regulatory hurdles when expanding indications.

Opportunities:

• Development of biomarkers for personalized therapy.
• Expansion in emerging markets with rising prostate cancer prevalence.
• Formulation improvements and combination regimens.

Key Takeaways

• Abiraterone acetate remains a significant player in prostate cancer therapy.
• Patent expiration in key markets prompts a shift toward generics, impacting revenues.
• Competition from other oral anti-androgens affects market share but leaves room for growth through expanded indications.
• Market value is projected to stabilize short-term before gradual growth resumes with new therapies and indications.

FAQs

1. How does patent expiry affect abiraterone acetate’s pricing?
Patent expiry introduces generic competition, leading to significant price reductions and pressure on branded sales.

2. What are the main competitors to abiraterone acetate?
Enzalutamide (Xtandi), apalutamide (Erleada), and darolutamide (Nubeqa) are primary competitors.

3. What markets are expanding for abiraterone acetate?
Emerging markets, such as Asia-Pacific, show increased adoption due to rising prostate cancer prevalence and expanding healthcare infrastructure.

4. Can abiraterone acetate be used in earlier prostate cancer stages?
Yes. Recent approvals include use in metastatic hormone-sensitive prostate cancer (mCSPC), broadening its application.

5. How might future development impact its market?
Ongoing development of biomarkers, combination regimens, and expanded indications could restore growth momentum despite generic competition.

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References

[1] Market research reports, 2023.
[2] FDA approvals database.
[3] European Medicines Agency (EMA) approvals.
[4] Johnson & Johnson (2023). Zytiga product dossier.
[5] International prostate cancer market analysis, 2022.