ZYTIGA Drug Patent Profile

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

Zytiga is a drug marketed by Janssen Biotech and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zytiga

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

Summary for ZYTIGA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	117
Drug Prices:	Drug price information for ZYTIGA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZYTIGA
What excipients (inactive ingredients) are in ZYTIGA?	ZYTIGA excipients list
DailyMed Link:	ZYTIGA at DailyMed

See drug prices for ZYTIGA

Recent Clinical Trials for ZYTIGA

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

Sponsor	Phase
Mayo Clinic	PHASE2
Merck Sharp & Dohme LLC	Phase 3
Orion Corporation, Orion Pharma	Phase 3

See all ZYTIGA clinical trials

Pharmacology for ZYTIGA

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 ZYTIGA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
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 ZYTIGA

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	202379-001	Apr 28, 2011	AB	RX	Yes	No
Janssen Biotech	ZYTIGA	abiraterone acetate	TABLET;ORAL	202379-002	Apr 14, 2017	AB	RX	Yes	Yes

Expired US Patents for ZYTIGA

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 ZYTIGA

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 ZYTIGA

See the table below for patents covering ZYTIGA around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	9509178
South Korea	20090059126
Australia	7661894
Portugal	2478907
Mexico	9301525	ESTERIODES SUBSTITUIDOS EN LA POSICION 17 Y COMPOSICION FARMACEUTICA QUE LOS CONTIENE.
Spain	2869343
Australia	2015221447

Supplementary Protection Certificates for ZYTIGA

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
0633893	CA 2011 00035	Denmark
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	91911	Luxembourg		91911, EXPIRES: 20180315
0633893	C300508	Netherlands		PRODUCT NAME: ABIRATERON ALSMEDE ZUURADDITIEZOUTEN EN 3-ESTERS ERVAN, IN HET BIJZONDER ABIRATERONACETAAT; NAT. REGISTRATION NO/DATE: EU/1/11/714/001 20110905; FIRST REGISTRATION:
0633893	1190040-4	Sweden		PRODUCT NAME: ABIRATERON OCH SYRAADDITIONSSALTER OCH 3-ESTRAR DAERAV, SPECIELLT ABIRATERON-ACETAT; REG. NO/DATE: 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

Market Dynamics and Financial Trajectory for ZYTIGA (Abiraterone Acetate)

Last updated: November 20, 2025

Introduction

ZYTIGA (abiraterone acetate) has established itself as a cornerstone in the treatment of metastatic castration-resistant prostate cancer (mCRPC). Developed jointly by Johnson & Johnson's Janssen Pharmaceuticals and Cougar Biotechnology (later acquired by Johnson & Johnson in 2011), ZYTIGA has transformed prostate cancer management, fueling substantial market growth and influencing pipeline developments. This comprehensive analysis examines the evolving market dynamics and financial trajectory of ZYTIGA within the prostate cancer treatment landscape, with a focus on key factors driving growth, competitive positioning, regulatory influences, and future prospects.

Overview of ZYTIGA and Its Therapeutic Profile

Approved by the U.S. Food and Drug Administration (FDA) in 2011, ZYTIGA functions as an androgen biosynthesis inhibitor, targeting CYP17A1 enzyme activity to suppress androgen production—a critical driver in prostate cancer progression. Its indication expanded from mCRPC to include metastatic hormone-sensitive prostate cancer (mHSPC) based on clinical trial data, notably the LATITUDE and STAMPEDE trials, further broadening its therapeutic scope. ZYTIGA's convenience as an oral agent and its demonstrated efficacy contributed to rapid adoption in clinical practice.

Market Dynamics

1. Market Drivers

a. Rising Incidence of Prostate Cancer

Prostate cancer remains the second most common cancer among men worldwide, with global incidence projected to exceed 1.4 million cases annually by 2025 [1]. Aging populations, increased screening, and improved diagnostic techniques contribute to rising diagnosed cases, expanding the potential market for androgen-targeted therapies like ZYTIGA.

b. Advancements in Clinical Evidence

The robust clinical efficacy demonstrated by ZYTIGA across multiple trials, including its ability to prolong overall survival and improve quality of life in advanced prostate cancer, has resulted in widespread clinician adoption. Its approval for mHSPC in 2018, based on the STAMPEDE and LATITUDE trial data, positioned ZYTIGA as a first-line option across disease stages.

c. Preference for Oral Therapeutics

The shift toward oral, outpatient treatment options enhances patient compliance and reduces healthcare resource utilization. ZYTIGA's oral administration aligns with these trends, making it an attractive choice for both physicians and patients.

d. Combination Therapy Approaches

The integration of ZYTIGA with other agents, such as androgen receptor signaling inhibitors (e.g., enzalutamide) and chemotherapy, has demonstrated additive benefits. Such combination strategies extend market reach and redefine standard care protocols.

2. Market Challenges

a. Competition from Emerging Agents

The prostate cancer therapeutic landscape has become increasingly crowded, with novel agents such as relugolix (a GnRH antagonist), apalutamide, and darolutamide offering alternative mechanisms and toxicity profiles. Enzalutamide, another androgen receptor pathway inhibitor, directly competes with ZYTIGA for similar indications.

b. Patent Expiry and Generic Entry

Patents protect ZYTIGA’s exclusivity until approximately 2027-2029. However, once expired, generic versions threaten sales, compelling Janssen to strategically extend patent life through formulation patents, new indications, and combination therapies.

c. Side Effect Profile and Patient Selection

Adverse events like hepatotoxicity, hypertension, hypokalemia, and fluid retention necessitate careful patient monitoring. The emergence of therapies with more favorable safety profiles influences prescribing patterns.

3. Regulatory and Reimbursement Environment

a. Global Regulatory Approvals

ZYTIGA has secured approvals across North America, Europe, Asia, and other regions. Each jurisdiction's regulatory agency has specific data requirements, affecting launch timelines and market penetration.

b. Price and Reimbursement Policies

Reimbursement frameworks, pricing negotiations, and health technology assessments (HTAs) in key markets shape accessibility. Payers increasingly demand cost-effectiveness data, influencing formulary inclusion.

4. Geographic Market Penetration

a. North America

North America remains ZYTIGA’s largest market, driven by high prostate cancer prevalence, advanced healthcare infrastructure, and favorable reimbursement policies. The U.S. accounts for approximately 50% of sales, with steady growth driven by new indications and combination use.

b. Europe and Asia-Pacific

European markets have shown strong uptake, particularly following approvals for mHSPC and combination regimens. Emerging markets in Asia-Pacific offer high growth potential due to increasing diagnosis rates, although access barriers and pricing challenges remain.

Financial Trajectory

1. Revenue Trends

Since its launch, ZYTIGA experienced rapid revenue growth. Johnson & Johnson reported peak sales exceeding $3 billion globally in 2018–2019, driven by expanding indications and high prescribing rates in the U.S. and Europe [2]. Post-2019, sales stabilized, influenced by market saturation, patent expiration preparations, and emerging competition.

2. Impact of Patent Expiration and Biosimilars

While ZYTIGA’s patent protection remains robust, impending patent cliffs threaten future revenues. The company has responded through diversification, marketing legacy brand strength, and developing next-generation formulations. Additionally, legal strategies to extend patent life and in-licensing or acquiring competitors’ technology underpin future financial planning.

3. Pipeline and Next-Generation Therapies

Janssen is investing in next-generation androgen receptor modulators and combination regimens. The development of orally bioavailable, more selective CYP17 inhibitors with better safety profiles could either complement or replace ZYTIGA, influencing its long-term financial stability.

4. Strategic Collaborations and Market Expansion

Expansion into emerging markets via licensing, strategic alliances, and local manufacturing are vital to offset saturation in mature markets. Global pricing strategies tailored to regional healthcare economics are integral to sustaining revenue streams.

Future Outlook

The ZYTIGA market is poised for moderate growth in the short term, driven by new indications, combination practices, and increased prostate cancer prevalence. However, long-term prospects hinge on pipeline innovation, market penetration in emerging regions, and the competitive landscape’s evolution. The impending patent expiry necessitates anticipation of biosimilar competition and strategic market defenses.

Key Factors Influencing ZYTIGA’s Market and Financial Trajectory

• Clinical Evidence & Regulatory Approvals: Strong trial data and expanded indications underpin market expansion.
• Competitive Dynamics: The rise of alternative androgen receptor inhibitors and GnRH antagonists pressures ZYTIGA’s market share.
• Pricing & Reimbursement: Favorable reimbursement in key markets sustains revenue, while payor assertiveness could constrain growth.
• Patent Life & Biosimilars: Approaching patent expiry compels strategic innovation and diversification.
• Geographic Penetration: Emerging markets offer growth opportunities, contingent on regulatory, economic, and healthcare infrastructure developments.

Key Takeaways

• Market Growth: The prostate cancer landscape, driven by aging populations and increased screening, supports sustained demand for ZYTIGA, especially in combination regimens.
• Competitive Positioning: While currently a market leader, ZYTIGA faces intense competition from newer agents and biosimilars, necessitating strategic differentiation.
• Regulatory & Pricing Strategies: Navigating global regulatory environments and optimizing reimbursement remain critical for sustained revenue.
• Pipeline & Innovation: Investment in next-generation therapies and formulations will be essential to extending ZYTIGA’s market relevance.
• Long-Term Outlook: Near-term growth is promising, but patent expiries and competitive pressures highlight the importance of ongoing innovation and market diversification.

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FAQs

1. What is the primary mechanism of action of ZYTIGA?
ZYTIGA inhibits CYP17A1, an enzyme critical for androgen biosynthesis, thereby reducing androgen levels that fuel prostate cancer growth.

2. How has the approval of ZYTIGA for mHSPC affected its market dynamics?
Approval for mHSPC significantly expanded its market, positioning ZYTIGA as a first-line treatment in earlier disease stages and increasing sales volume substantially.

3. What are the main competitors to ZYTIGA?
Enzalutamide, apalutamide, darolutamide, and relugolix are primary competitors, offering similar or alternative therapeutic mechanisms with varying safety and convenience profiles.

4. How does patent expiry impact ZYTIGA’s financial outlook?
Patent expiration around 2027-2029 risks biosimilar competition, potentially eroding market share and revenue unless offset by new indications, formulations, or pipeline products.

5. What factors could influence ZYTIGA’s future market share?
Emerging therapies, regulatory decisions, reimbursement policies, pricing strategies, and global market penetration efforts will influence its long-term competitiveness.

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References:

[1] International Agency for Research on Cancer. "Global Cancer Statistics 2020."

[2] Johnson & Johnson Annual Reports, 2018–2022.