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, 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 fifteen 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-four suppliers are listed for this compound.

Summary for ABIRATERONE ACETATE

International Patents:	61
US Patents:	15
Tradenames:	4
Applicants:	15
NDAs:	18
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	24
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	216793-001	Aug 11, 2023		RX	Yes	No	8,071,623		Y	Y
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-001	Aug 11, 2023		RX	Yes	No	11,986,470
Apotex	ABIRATERONE ACETATE	abiraterone acetate	TABLET;ORAL	208453-001	Oct 31, 2018	AB	RX	No	No
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-001	Aug 11, 2023		RX	Yes	No	8,071,579
Janssen Biotech	AKEEGA	abiraterone acetate; niraparib tosylate	TABLET;ORAL	216793-001	Aug 11, 2023		RX	Yes	No	11,673,877		Y	Y

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
South Korea	20170070025
Hong Kong	1219457
South Korea	20160023641	아비라테론 아세테이트 제제 (ABIRATERONE ACETATE FORMULATION)
Hong Kong	1219457	乙酸阿比特龍酯製劑 (ABIRATERONE ACETATE FORMULATION)
South Korea	102491439

Supplementary Protection Certificates for ABIRATERONE ACETATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
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	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	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

ABIRATERONE ACETATE: Market Dynamics and Financial Trajectory

Last updated: April 24, 2026

What is the commercial footprint of abiraterone acetate today?

Abiraterone acetate (brand: Zytiga; originally Janssen) is a high-value oncology product whose market has shifted from early-line metastatic castration-resistant prostate cancer (mCRPC) toward expanded metastatic states and earlier disease segments, while facing intensifying competitive pressure from next-generation androgen receptor (AR) therapies and patent-driven erosion in select geographies.

Core commercial context

• Product identity: abiraterone acetate is the established AR-pathway inhibitor used primarily in advanced prostate cancer settings.
• Therapeutic positioning: the drug class competes with AR inhibitors (enzalutamide, apalutamide, darolutamide) and, in later lines, with AR-pathway sequencing strategies and combination regimens that can compress the share of standalone abiraterone.

Market dynamic pattern seen in advanced prostate cancer

• When a class leader expands into new lines, incremental demand rises before substitution accelerates after competitors receive label expansions.
• Sales growth then typically transitions to plateau as payer coverage policies, sequencing practices, and competitive pricing shift.

How do label scope and sequencing influence demand?

Abiraterone acetate’s demand has historically tracked with how clinicians sequence AR inhibitors and integrate combinations in metastatic prostate cancer.

Demand drivers

• Earlier adoption: label expansions into broader metastatic states increased addressable patient populations.
• Regimen integration: real-world prescribing cycles between AR inhibitors, with abiraterone often used based on prior exposure, comorbidity profiles, and payer criteria.
• Combination effects: in practice, treatment selection reflects emerging preference for regimens that demonstrate improved survival and tolerability in specific subgroups.

Key market dynamic: sequencing compression

• With multiple AR inhibitors in the same therapeutic neighborhood, each new approval that expands eligible populations tends to reduce the marginal benefit of any one product over time.
• That creates a typical commercial trajectory: initial share gains after label expansion, followed by share dilution as competitive options broaden.

What are the primary competitive pressures on revenue?

Abiraterone acetate operates in a crowded AR inhibitor landscape.

Competitive set

• Enzalutamide (AR inhibitor)
• Apalutamide (AR inhibitor)
• Darolutamide (AR inhibitor)

Mechanisms of pressure

• Therapy substitutability: all are AR-pathway inhibitors used across overlapping metastatic settings.
• Sequencing flexibility: clinicians can substitute among AR options with similar treatment goals, using patient-specific tolerability and prior exposure.
• Payer management: step therapy and formulary tiering can drive product switching even when clinical benefit remains comparable in practice.

How do patent and exclusivity effects shape financial trajectory?

Patent-driven erosion is the structural variable that typically changes the slope of revenue after periods of premium pricing and market dominance.

Trajectory shape

1. Exclusivity premium period: brand pricing plus limited generic availability supports higher net sales and stable contribution margins.
2. Erosion window: generic or authorized generics entering major markets reduce price levels and force contracting of revenue per patient.
3. Post-erosion stabilization: remaining market depends on brand loyalty, access contracts, and the company’s ability to defend net price through contracting.

Business implication

• For branded oncology products, the financial profile often transitions from “volume growth from label expansion” to “net sales decline from price compression,” while any remaining growth must come from access and indication expansion rather than pure market share.

What do the financial trajectory patterns typically look like for this category?

For AR inhibitor franchises in metastatic prostate cancer, financial paths often follow a predictable sequence driven by approvals and competitive entry.

Expected trajectory for abiraterone acetate

• Period of expansion: label growth and line-of-therapy adoption increase demand.
• Competitive plateau: multiple AR inhibitors share the same patient pools; substitution increases.
• Erosion phase: patent-related entry reduces net price.
• Late stabilization: brand sales persist where contracts, hospital formularies, and physician familiarity support continued use.

Where does abiraterone acetate fit versus the newest AR options in market behavior?

The market behavior among AR inhibitors is shaped less by clinical differentiation and more by practical adoption constraints: payer access, dosing convenience, and the sequencing norms that evolve after new label data.

Practical adoption levers

• Cost and contracting: net price and rebate structures influence formulary position.
• Treatment pathway integration: how each therapy fits into current prostate cancer care pathways.
• Tolerability management: clinical practice favors drugs that align with patient comorbidity and monitoring capability.

What is the likely revenue risk profile (drivers and headwinds)?

Revenue headwinds

• Share loss from competing AR inhibitors
• Net price compression from patent challenges and generic entry dynamics
• Formulary narrowing as payer policy standardizes among therapeutically similar options
• Sequencing shifts as practice patterns evolve with new evidence and label updates

Revenue supports

• Ongoing patient pool in advanced prostate cancer that sustains baseline demand
• Contracted access that can temporarily protect net pricing
• Residual brand preference in specific healthcare systems

How do market dynamics translate into financial metrics?

Abiraterone acetate’s financial trajectory is driven by three linked variables:

1. Volume (eligible patients and line-of-therapy share)
2. Net price (discounts, rebates, payer contracting)
3. Mix (geographies, settings, and patient subgroups)

Operating translation

• Volume growth can slow as competitive choices expand.
• Net sales can decline even when volume is stable if net price compresses from generic entry or contracting.
• Mix shifts to lower-priced channels can further pressure revenue even if prescriptions persist.

What does a scenario map for abiraterone acetate financial trajectory look like?

Below is a decision-useful scenario map showing how market events typically affect the financial outcome.

Scenario	Volume trend	Net price trend	Net sales trajectory	Business read-through
Competitive intensification without major access loss	Flat to modest decline	Flat to modest decline	Plateau	Share erosion offsets net price protection
Generic/authorized entry in key geographies	Decline	Sharp decline	Downward slope	Price compression dominates even with residual volume
Strong label-linked adoption plus protected contracting	Upward	Stable	Growth then plateau	Adoption offsets competitive substitution
Sequencing practice shifts toward newer agents	Downward	Decline	Decline accelerates	“Line-of-therapy” loss compresses demand

What data points should investors track for quarterly read-through?

For abiraterone acetate, the most informative quarterly indicators tend to be the ones that reflect payer access and pricing, not just unit demand.

Quarterly indicators

• Net sales growth rate versus volume growth proxies (where available)
• Geographic split between markets with different patent/generic status
• Formulary status changes via payer contracting narratives
• Inventory and channel fill behavior that can distort near-term unit trends

How does this product’s market evolution compare to sector norms?

In advanced prostate cancer, the AR inhibitor market typically shows:

• Rapid competitive expansion after multiple label wins
• Substitution as treatment pathways standardize
• Event-driven revenue shifts after patent expiry

Abiraterone acetate follows that archetype: label-led expansion created momentum; subsequent competition and access policies have driven a later plateau-to-erosion pattern consistent with mature oncology brands.

Key Takeaways

• Abiraterone acetate’s commercial trajectory is dominated by advanced prostate cancer sequencing, where multiple AR inhibitors compete for overlapping patient pools.
• Financial outcomes depend on three levers: volume share in each metastatic setting, net price via payer contracting, and patent or exclusivity status that governs generic pressure.
• The category typically transitions from label-expansion-driven growth to competitive plateau and then to price-driven decline after exclusivity erosion.
• For decision-making, quarterly emphasis should sit on net sales versus volume signals and on geographic/payer mix that reflects where price compression is occurring.

FAQs

1. What factor most strongly determines abiraterone acetate net sales over time?
   Net price under payer contracting and exclusivity/generic status.

2. Why does abiraterone acetate face sustained revenue pressure even after label expansions?
   Because competing AR inhibitors cover overlapping disease states, enabling substitution and sequencing changes.

3. Does volume always decline when revenues decline for abiraterone acetate?
   No. Revenue can fall primarily from net price compression even if prescription volumes remain stable.

4. What market event most often changes the revenue slope for mature oncology brands?
   Patent expiry or generic/authorized generic entry in major markets.

5. What is the most decision-relevant indicator for near-term read-through?
   Net sales growth relative to unit/volume proxies, plus changes in payer access by geography.

References

[1] U.S. Food and Drug Administration. ZYTIGA (abiraterone acetate) prescribing information. FDA label documents.
[2] European Medicines Agency. Zytiga (abiraterone acetate) product information and EPAR documentation.
[3] Janssen Biotech. ZYTIGA (abiraterone acetate) official product information and label updates.