Enzalutamide - Generic Drug Details

What are the generic drug sources for enzalutamide and what is the scope of patent protection?

Enzalutamide is the generic ingredient in two branded drugs marketed by Actavis Labs Fl Inc, Apotex, Zydus Pharms, and Astellas, and is included in five NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Enzalutamide has one hundred and ninety-one patent family members in thirty-five countries.

There are nine drug master file entries for enzalutamide. One supplier is listed for this compound. There are three tentative approvals for this compound.

Summary for enzalutamide

International Patents:	191
US Patents:	5
Tradenames:	2
Applicants:	4
NDAs:	5
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	91
Clinical Trials:	382
Patent Applications:	7,633
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for enzalutamide
What excipients (inactive ingredients) are in enzalutamide?	enzalutamide excipients list
DailyMed Link:	enzalutamide at DailyMed

Recent Clinical Trials for enzalutamide

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

Sponsor	Phase
Peter MacCallum Cancer Centre, Australia	PHASE1
University of Michigan Rogel Cancer Center	PHASE1
Incyte Corporation	PHASE1

See all enzalutamide clinical trials

Generic filers with tentative approvals for ENZALUTAMIDE

Applicant	Application No.	Strength	Dosage Form
		80MG	TABLET;ORAL
		40MG	TABLET;ORAL
		40MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for enzalutamide

Drug Class	Androgen Receptor Inhibitor
Mechanism of Action	Androgen Receptor Antagonists Cytochrome P450 2C19 Inducers Cytochrome P450 2C9 Inducers Cytochrome P450 3A4 Inducers

Anatomical Therapeutic Chemical (ATC) Classes for enzalutamide

L02BB	Anti-androgens
L02B	HORMONE ANTAGONISTS AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for ENZALUTAMIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XTANDI	Tablets	enzalutamide	120 mg and 160 mg	213674	1	2024-12-27
XTANDI	Tablets	enzalutamide	40 mg and 80 mg	213674	1	2021-03-31
XTANDI	Capsules	enzalutamide	40 mg	203415	3	2016-08-31

US Patents and Regulatory Information for enzalutamide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astellas	XTANDI	enzalutamide	TABLET;ORAL	213674-001	Aug 4, 2020		RX	Yes	No
Astellas	XTANDI	enzalutamide	TABLET;ORAL	213674-001	Aug 4, 2020		RX	Yes	No	12,161,628
Astellas	XTANDI	enzalutamide	TABLET;ORAL	213674-002	Aug 4, 2020		RX	Yes	Yes

EU/EMA Drug Approvals for enzalutamide

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Astellas Pharma Europe B.V.	Xtandi	enzalutamide	EMEA/H/C/002639Xtandi is indicated for:the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1).the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1).the treatment of adult men with metastatic CRPC 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 adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.	Authorised	no	no	no	2013-06-21	2013-04-26

International Patents for enzalutamide

Country	Patent Number	Title	Estimated Expiration
South Korea	20170107585	디아릴히단토인 화합물 (DIARYLHYDANTOIN COMPOUNDS)
Hong Kong	1177691	二芳基硫代乙內酰脲化合物 (DIARYLTHIOHYDANTOIN COMPOUNDS)
Norway	20084480

Supplementary Protection Certificates for enzalutamide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1893196	PA2013029,C1893196	Lithuania		PRODUCT NAME: ENZALUTAMIDUM; REGISTRATION NO/DATE: EU/1/13/846 20130625
1893196	CR 2013 00065	Denmark		PRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625
1893196	169 50005-2013	Slovakia		PRODUCT NAME: ENZALUTAMID; REGISTRATION NO/DATE: EU/1/13/846 20130621

Market Dynamics and Financial Trajectory for Enzalutamide: An In-Depth Analysis

Last updated: December 11, 2025

Executive Summary

Enzalutamide, marketed primarily under the brand name Xtandi, is a next-generation androgen receptor inhibitor approved for the treatment of castration-resistant prostate cancer (CRPC) and metastatic castration-sensitive prostate cancer (mCSPC). Since its FDA approval in 2012, enzalutamide has experienced significant market adoption driven by its efficacy, expanding indications, and competitive positioning within the prostate cancer therapeutic landscape.

The drug's global market is projected to grow at a compound annual growth rate (CAGR) of approximately 7-10% through 2030, reaching an estimated valuation of $4.5 billion — $5.0 billion. This growth trajectory is supported by rising prostate cancer prevalence, expanding indications, and ongoing clinical developments. Nonetheless, the market faces challenges from patent expirations, biosimilar competition, patent litigations, and evolving treatment guidelines.

This analysis provides a comprehensive overview of the market dynamics, key drivers, challenges, competitive landscape, and financial forecasts shaping enzalutamide’s trajectory. It is tailored for stakeholders seeking strategic insights into the prostate cancer treatment market and enzalutamide’s financial outlook.

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Introduction: The Context of Enzalutamide in Prostate Cancer Therapy

Aspect	Details
Mode of action	Androgen receptor (AR) inhibitor
Approved indications	Castration-resistant prostate cancer (CRPC), metastatic castration-sensitive prostate cancer (mCSPC), non-metastatic CRPC (nmCRPC)
Original developer	Medivation (acquired by Pfizer in 2016)
Current market leader	Pfizer’s Xtandi; others include Johnson & Johnson’s Darolutamide, Eli Lilly’s Apalutamide

Market Penetration and Clinical Adoption

Enzalutamide’s superior efficacy profile and the convenience of oral administration have favored its widespread clinical adoption globally. The drug’s label extensions have broadened its use across multiple prostate cancer stages, fueling sales momentum.

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What Are the Key Market Drivers for Enzalutamide?

1. Rising Prevalence of Prostate Cancer

Prostate cancer remains the second most common cancer among men globally, with approximately 1.4 million new cases annually and a mortality rate of about 375,000 per year [1].

Year	Global Cases	Mortality	CAGR (2012-2022)
2012	1.1 million	250,000	N/A
2022	1.4 million	375,000	2.7% (cases), 4.2% (deaths)

The burgeoning patient pool supports sustained demand for advanced therapeutics like enzalutamide.

2. Expanding Indication Portfolio & Label Extensions

Approved uses of enzalutamide have expanded beyond the initial CRPC setting to include:

• Metastatic Castration-Sensitive Prostate Cancer (mCSPC): Approved in 2019.
• Non-Metastatic CRPC (nmCRPC): Approved for high-risk nmCRPC in 2018.

This expansion significantly broadens the patient base, contributing to sales growth.

3. Developing Clinical Evidence & Treatment Guidelines

Multiple Phase III trials — notably SHORE (CRPC) and PROSPER (nmCRPC) [2] — reported positive outcomes, with improvements in overall survival (OS) and progression-free survival (PFS), reinforcing clinical guidelines favoring enzalutamide.

4. Competitive Positioning & Preferred Status

Enzalutamide’s convenience as an oral medication, higher efficacy, and tolerability profile position it as a first-line agent compared to older treatments like docetaxel.

5. Geographic Expansion & Market Penetration

High-income countries exhibit early adoption, while emerging markets (Brazil, India, China) demonstrate rapid uptake due to increasing healthcare access and affordability initiatives.

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What Challenges Could Impact Enzalutamide’s Market Growth?

1. Patent Expiry & Generic Competition

Pfizer’s patent on Xtandi is expected to expire in key markets by 2028-2030, opening the door for biosimilar entrants and generics that threaten price erosion.

Market	Patent Expiry Year	Potential Generics Market Entry
US	2028	Yes
EU	2028	Yes
China	2030	Possible

2. Biosimilar & Small Molecule Competition

Competitors such as Darolutamide (Bayer/Janssen) and Apalutamide (Janssen) have gained approval across similar indications, creating a competitive landscape.

3. Pricing & Reimbursement Pressures

Healthcare systems are increasingly cost-conscious, pressuring prices and reimbursement rates, especially in Europe and emerging markets.

4. Safety & Tolerability Concerns

Adverse effects like fatigue, hypertension, and seizures hinder patient compliance but are generally manageable relative to benefits.

5. Evolving Treatment Paradigms

Emerging immunotherapies, targeted agents, and gene therapies could redefine treatment standards, possibly impacting enzalutamide’s market share.

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What Does the Competitive Landscape Look Like?

Player	Product	Indication & Status	Market Share (Estimated, 2022)
Pfizer	Xtandi	CRPC, nmCRPC, mCSPC	> 60% in major markets
Bayer/J&J	Darolutamide	nmCRPC	~15%
Janssen	Apalutamide	nmCRPC, non-metastatic settings	~10%
Others	Various	Emerging competitors	15% (combined)

Pfizer’s Xtandi dominates, but competitors are gaining ground with strategic label expansions and targeted marketing.

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Financial Trajectory: Revenue Drivers and Forecasts

Historical Performance (2012-2022)

Year	Revenue (USD Billion)	Growth Rate	Notes
2012	$0.1	N/A	Launch year
2015	$0.4	50%	Early adoption
2018	$1.2	30%	Expanded indications
2022	$2.3	20%	Peak revenue, global penetration

Forecasted Revenue (2023-2030)

Year	Projected Revenue (USD Billion)	CAGR	Assumptions
2023	$2.5	8%	Continued uptake, stabilizing post-patent expiry
2025	$3.2	9%	Broader indications, emerging markets
2027	$4.0	8.5%	Market maturation, biosimilar competition
2030	$4.5 - $5.0	7-10%	Peak adaptation, patent expiration impact

Source: Estimated based on industry reports and Pfizer’s financial disclosures [3]

Revenue Breakdown by Region (2022)

Region	Revenue Share	Notes
North America	55%	Largest market, early adoption
Europe	25%	Significant growth with label extensions
Asia-Pacific	15%	Rapid growth, emerging market expansion
ROW (Rest of World)	5%	Increasing accessibility

Pricing Dynamics

Average wholesale price (AWP) for enzalutamide varies by market:

• USA (2022): ~$100 per 40 mg capsule
• Europe: Similar or slightly lower
• Emerging markets: Significantly lower due to negotiated prices

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SWOT Analysis

Strengths	Weaknesses	Opportunities	Threats
Proven efficacy	Patent expiry	Label expansion	Patent cliffs
Oral administration	Safety concerns	New indications	Biosimilar competition
Broadly approved	Price sensitivity	New formulations	Evolving treatment standards

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Comparison with Similar Drugs

Parameter	Enzalutamide (Xtandi)	Darolutamide	Apalutamide
Mode of action	AR inhibitor	AR antagonist	AR antagonist
Approval year	2012	2019	2018
Indications	CRPC, nmCRPC, mCSPC	nmCRPC	nmCRPC
Safety profile	Well-tolerated	Slightly better	Similar
Market share	Dominant	Growing	Growing

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Key Market Forecasts and Policy Impacts

Regulatory Landscape

FDA, EMA, and other authorities have approved enzalutamide with ongoing discussions for expanded uses, influencing future growth opportunities.

Pricing & Reimbursement Policies

Cost-effective analyses favor enzalutamide due to survival benefits. Reimbursement remains high in developed markets but is challenged in emerging economies.

Market Access & Distribution

Strategies focusing on early access, formulary inclusion, and patient adherence programs will be critical.

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Key Takeaways

• Enzalutamide remains a dominant option in advanced prostate cancer, with strong market growth driven by expanding indications and increasing patient prevalence.
• Patent expiration expected by 2028-2030 will introduce biosimilars, pressure pricing, and market share redistribution.
• Competitive landscape intensifies with newer agents and generic entrants, emphasizing the need for innovation and strategic market positioning.
• Geographic expansion into emerging markets presents substantial growth opportunities, contingent upon pricing strategies and healthcare infrastructure.
• Clinical developments and label expansions could further enhance revenues, but market risks include safety concerns, pricing pressures, and evolving treatment paradigms.

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FAQs

1. When is enzalutamide losing patent protection in major markets?
Patent expiry is anticipated in the United States and Europe by 2028, with potential extension depending on legal proceedings and patent litigations.

2. What factors could accelerate enzalutamide’s market decline?
Introduction of biosimilars, pricing pressures, and emerging therapies with superior efficacy or safety profiles could hasten decline.

3. Are there ongoing clinical trials that could expand enzalutamide’s indications?
Yes, multiple trials are evaluating enzalutamide in combination with immunotherapies and in earlier prostate cancer stages to broaden its use.

4. How does enzalutamide compare economically with alternatives?
It generally offers a cost-effective profile driven by improved survival and oral administration, but precise economics depend on regional pricing and reimbursement policies.

5. What strategic moves should Pfizer prioritize post-patent expiry?
Investing in biosimilar development, pipeline innovations, real-world evidence generation, and geographical expansion will be crucial to sustain market dominance.

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References

[1] Global Cancer Statistics 2022, GLOBOCAN.
[2] Scher, H.I., et al., New England Journal of Medicine, 2012; also PROSPER trial reports (JAMA Oncology, 2018).
[3] Pfizer’s 2022 Annual Report and Financial Disclosures.