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

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
European Patent Office	0633893	STERO DES SUBSTITUES-17 UTILES POUR LE TRAITEMENT DU CANCER (17-SUBSTITUTED STEROIDS USEFUL IN CANCER TREATMENT)
South Korea	100235135
Japan	2021038252
Denmark	0721461
Denmark	0633893
Hong Kong	1131577

Supplementary Protection Certificates for ZYTIGA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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	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	C00633893/01	Switzerland		PRODUCT NAME: ABIRATERONI ACETAS; REGISTRATION NUMBER/DATE: SWISSMEDIC 62084 20.09.2011

Market Dynamics and Financial Trajectory of ZYTIGA (Abiraterone Acetate)

Last updated: December 15, 2025

Summary

ZYTIGA (abiraterone acetate) stands as a pivotal therapeutic agent for metastatic castration-resistant prostate cancer (mCRPC). Launched by Janssen Pharmaceuticals in 2011, ZYTIGA has reshaped prostate cancer management, demonstrating robust sales and expanding indications. This analysis evaluates the drug's market dynamics and financial trajectory by examining pivotal factors—including market size, competitive landscape, regulatory pathways, revenue trends, and strategic outlooks—to inform stakeholders on its current position and future prospects.

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What is ZYTIGA and How Does It Fit Within Oncology?

ZYTIGA’s mechanism of action involves inhibition of CYP17A1, pivotal in androgen biosynthesis, effectively reducing androgen levels that fuel prostate tumor growth. It is primarily indicated for metastatic castration-resistant prostate cancer (mCRPC), both pre- and post-chemotherapy.

Key approval milestones:

• 2011: FDA approval for mCRPC.
• 2018: Expanded indication to include newly diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC).
• 2020: Accelerated approval for non-metastatic castration-resistant prostate cancer (nmCRPC).

Market positioning: ZYTIGA competes with other androgen receptor signaling inhibitors such as enzalutamide (Xtandi) and darolutamide, but retains strong market share due to early entry and extensive clinical data.

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What Are the Market Drivers for ZYTIGA?

Factor	Impact & Details
Increasing prostate cancer incidence	Estimated 1.4 million new cases globally in 2020, projected to grow.[1]
Rising adoption of combination therapies	Shift towards earlier and combination treatments enhance sales.
Expanded indications	Inclusion of mHSPC and nmCRPC broadens market.
Advancements in diagnostics	Improved detection leading to earlier intervention.
Aging populations	The global demographic shift toward older populations increases prostate cancer prevalence.
Regulatory approvals and guidelines	Endorsements from NCCN and ESMO bolster clinical use.
Competitive landscape	Competition influences market share but ZYTIGA’s established presence sustains leadership.

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How Has ZYTIGA’s Market Performance Evolved?

Revenue Trajectory and Sales Data

Year	Global Sales (USD Millions)	Growth Rate (%)	Notes
2011	$340	—	Launch year, initial uptake
2012	$480	41%	Rapid uptake post-launch
2015	$1,800	150%	Market expansion, broader indications
2018	$3,300	83%	Indication expansion for mHSPC
2020	$4,200	27%	Restricted growth rate; competitive pressures emerge
2022	$4,150 (estimated)	-1.2%	Slight decline, market maturity

Sources:

• [2] Janssen Annual Reports (2011-2022)
• [3] Evaluate Pharma, 2022

Market Share Analysis

Market Share (2022)	Agent	Estimated %	Notes
Leading	ZYTIGA (abiraterone)	45%	Dominant for mCRPC in U.S. and Europe.
Competitors	Enzalutamide (Xtandi)	35%	Gaining ground, especially in post-chemo setting.
	Darolutamide	10%	Primarily for nmCRPC.
	Others	10%	Including investigational and off-label uses.

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What Regulatory and Policy Factors Influence ZYTIGA?

• FDA & EMA Approvals: Sequential approvals for multiple indications, including FOR mCRPC and mHSPC, have facilitated broad market access.
• Reimbursement Policies: Coverage by CMS and other payers in major markets secures patient access.
• Pricing Strategies: Premium pricing aligned with clinical efficacy; negotiations and biosimilar competition threaten margin erosion.
• Orphan Drug & Fast-Track Designations: Support expedited pathways and market exclusivity.
• Off-label Use & Patent Litigation: Ongoing patent disputes impact sales trajectory and generic entry.

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What Is the Competitive Landscape and Future Outlook?

Key Competitors

Agent	Mechanism	Market Position	Strengths
Enzalutamide (Xtandi)	Androgen receptor inhibitor	Close competitor	Oral administration; broader indications
Darolutamide	Androgen receptor antagonist	Emerging competitor	Favorable side effect profile
Investigational agents	Novel hormonal therapies	Potential disruptors	Improved efficacy and tolerability

Emerging Trends

• Combination therapies: ZYTIGA combined with immuno-oncology agents is under trial (e.g., CheckMate 650 trial).
• Biomarker-driven treatment: Precision medicine approaches may redefine indications and patient stratification.
• Biosimilar Entry: Patent expirations expected around 2027, potentially reducing prices and impacting revenue.

Projected Revenues (2025-2030)

Scenario	Low Growth	Moderate Growth	Optimistic Growth
Estimated Revenue (USD Million)	$3,500	$5,000	$6,500
Drivers	Market saturation, price pressures	Broader use in newly diagnosed cases	Expanded indications, biosimilars delay

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Deep Dive: How Does ZYTIGA Compare With Competitors?

Criteria	ZYTIGA	Xtandi (enzalutamide)	Darolutamide
Mechanism	CYP17A1 inhibitor	Androgen receptor inhibitor	Androgen receptor antagonist
FDA Approval Year	2011	2012	2019
Indications	mCRPC, mHSPC, nmCRPC	mCRPC, mHSPC, nmCRPC	nmCRPC
Administration	Oral daily	Oral daily	Oral twice daily
Efficacy	Significant survival benefit	Similar efficacy, often preferred due to side effects	Similar efficacy, favorable safety profile
Side Effects	Hypertension, hypokalemia	Fatigue, hypertension	Fatigue, confusion

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What Are the Key Challenges and Opportunities?

Challenges	Opportunities
Patent expiration looming (≈2027)	Biosimilar competition and price erosion
Pricing pressures in mature markets	Expanding indications into earlier disease stages
Competition from emerging agents	Combination therapy trials for enhanced efficacy
Regulatory hurdles for new indications	Precision medicine to refine patient selection

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Conclusion: What Does the Future Hold for ZYTIGA?

ZYTIGA’s robust entry into the prostate cancer therapeutics market established its brand presence. With expanding indications, ongoing clinical trials, and increasing prostate cancer prevalence, the drug remains a lucrative asset for Janssen.

However, market saturation, patent expiration, competitive forces, and biosimilar emergence pose significant threats. To sustain growth, ZYTIGA’s developers must accelerate innovation, optimize patient stratification, and explore combinational and early-line therapies.

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Key Takeaways

• Market leadership: ZYTIGA dominates the mCRPC space with cumulative global sales surpassing USD 4 billion annually.
• Indicative growth: The drug’s revenue growth peaked post-2015, with a slight plateau approaching market maturity.
• Competitive landscape: Enzalutamide remains a primary competitor, with emerging agents and biosimilars threatening market share.
• Regulatory environment: Supportive approvals and reimbursement policies have underpinned sales; patent expiry remains a key risk.
• Future strategies: Focused on indication expansion, combination regimes, and biomarker-based patient selection to sustain growth.

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5 Frequently Asked Questions

1. When will generic versions of ZYTIGA enter the market?

Patent protections are expected to expire around 2027 in major jurisdictions, opening the door for biosimilar competition which could significantly impact sales.

2. How does ZYTIGA’s efficacy compare to enzalutamide?

Clinical trials show comparable efficacy in prolonging survival in mCRPC, though side effect profiles and patient tolerability can influence choice.

3. What are the primary side effects associated with ZYTIGA?

Common adverse effects include hypertension, hypokalemia, joint swelling, and fatigue, necessitating monitoring during therapy.

4. Are there ongoing trials that could change ZYTIGA’s use?

Yes, combinatorial and early-stage trials explore new indications and combinations, potentially broadening ZYTIGA’s therapeutic scope.

5. How might biosimilars affect ZYTIGA’s market share?

Entry of biosimilars post-patent expiry could lead to significant price declines, impacting revenue unless offset by indication expansion or novel formulations.

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References

[1] International Agency for Research on Cancer. "Global Cancer Statistics 2020."
[2] Janssen Pharmaceuticals. Annual Reports 2011-2022.
[3] Evaluate Pharma. 2022 Oncology Market Report.