XTANDI Drug Patent Profile

When do Xtandi patents expire, and what generic alternatives are available?

Xtandi is a drug marketed by Astellas and is included in two NDAs. There are five patents protecting this drug and three Paragraph IV challenges.

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

The generic ingredient in XTANDI is enzalutamide. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the enzalutamide profile page.

DrugPatentWatch^® Generic Entry Outlook for Xtandi

Xtandi was eligible for patent challenges on August 31, 2016.

There have been nine patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are three tentative approvals for the generic drug (enzalutamide), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for XTANDI

International Patents:	191
US Patents:	5
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	155
Patent Applications:	5,974
Drug Prices:	Drug price information for XTANDI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XTANDI
What excipients (inactive ingredients) are in XTANDI?	XTANDI excipients list
DailyMed Link:	XTANDI at DailyMed

See drug prices for XTANDI

Recent Clinical Trials for XTANDI

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

Sponsor	Phase
Merck Sharp & Dohme LLC	Phase 3
Orion Corporation, Orion Pharma	Phase 3
Prostate Cancer Foundation	Phase 1/Phase 2

See all XTANDI clinical trials

Pharmacology for XTANDI

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

Paragraph IV (Patent) Challenges for XTANDI

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 XTANDI

XTANDI is protected by fifteen US patents and one FDA Regulatory Exclusivity.

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	213674-002	Aug 4, 2020		RX	Yes	Yes
Astellas	XTANDI	enzalutamide	TABLET;ORAL	213674-001	Aug 4, 2020		RX	Yes	No
Astellas	XTANDI	enzalutamide	TABLET;ORAL	213674-002	Aug 4, 2020		RX	Yes	Yes	8,183,274
Astellas	XTANDI	enzalutamide	TABLET;ORAL	213674-002	Aug 4, 2020		RX	Yes	Yes	12,161,628
Astellas	XTANDI	enzalutamide	CAPSULE;ORAL	203415-001	Aug 31, 2012		RX	Yes	Yes	8,183,274
Astellas	XTANDI	enzalutamide	TABLET;ORAL	213674-002	Aug 4, 2020		RX	Yes	Yes	11,839,689		Y
Astellas	XTANDI	enzalutamide	CAPSULE;ORAL	203415-001	Aug 31, 2012		RX	Yes	Yes	12,161,628

EU/EMA Drug Approvals for XTANDI

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 XTANDI

When does loss-of-exclusivity occur for XTANDI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

Israel

Russian Federation

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering XTANDI around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20160027254	디아릴티오히단토인 화합물 (DIARYLTHIOHYDANTOIN COMPOUNDS)
Hong Kong	1177691	二芳基硫代乙內酰脲化合物 (DIARYLTHIOHYDANTOIN COMPOUNDS)
Croatia	P20150437
South Korea	101515335
Russian Federation	2638833	ДИАРИЛГИДАНТОИНЫ (DIARYL HYDANTOINS)
South Korea	20110041580	DIARYLHYDANTOIN COMPOUNDS
Hong Kong	1112856	DIARYLHYDANTOIN COMPOUND

Supplementary Protection Certificates for XTANDI

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
1893196	2013C/074	Belgium		PRODUCT NAME: ENZALUTAMIDE (ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/13/846 20130625
1893196	92338	Luxembourg		PRODUCT NAME: ENZALUTAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES (XTANDI); FIRST REGISTRATION DATE: 20130625
1893196	C20130036 00106	Estonia		PRODUCT NAME: ENSALUTAMIID;REG NO/DATE: K(2013)4019 (LOPLIK) 25.06.2013
1893196	CA 2013 00065	Denmark		PRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: XTANDI

Last updated: November 7, 2025

Introduction

XTANDI (enzalutamide) has emerged as a pivotal therapeutic agent in the management of prostate cancer since its approval by the U.S. Food and Drug Administration (FDA) in 2012. As a potent androgen receptor inhibitor, XTANDI has significantly altered the treatment landscape for metastatic castration-resistant prostate cancer (mCRPC), influencing market dynamics and financial trends within the oncology pharmaceutical sector. This analysis explores the key drivers shaping XTANDI’s market position, its revenue trajectory, competitive landscape, and future outlook.

Market Overview and Therapeutic Positioning

Prostate cancer remains one of the most common malignancies among men globally. The evolution from hormone-sensitive to castration-resistant stages marks a critical inflection point in disease management, with limited treatment options historically available for mCRPC. XTANDI’s mechanism—blocking androgen receptor signaling—addresses these therapeutic gaps effectively, positioning it as a first-line option in various treatment algorithms.

Its approval extended beyond initial indications, receiving additional approvals for non-metastatic castration-resistant prostate cancer (nmCRPC) in 2018, underscoring its expanding therapeutic utility. The increasing prevalence of prostate cancer, driven by aging demographics and improved diagnostic capabilities, underpins sustained demand for XTANDI.

Market Dynamics: Drivers and Barriers

Drivers

• Clinical Efficacy and Safety Profile: XTANDI demonstrates statistically significant improvements in overall survival (OS) compared to placebo in multiple clinical trials (e.g., PREVAIL and AFFIRM studies), fostering physician confidence and leading to widespread adoption.

• Regulatory Approvals and Label Expansion: Regulatory bodies globally have approved XTANDI for multiple indications, broadening its market applicability. The FDA’s approval for non-metastatic disease in 2018 notably expanded its user base.

• Growing Patient Population: Rising prostate cancer incidence worldwide, especially in developed economies, predicts an ongoing need for effective therapeutics like XTANDI.

• Competitive Positioning: Compared to traditional androgen deprivation therapies and chemotherapy, XTANDI offers oral administration, more favorable side effect profile, and survival benefits, reinforcing its preferred status.

Barriers

• Pricing and Reimbursement Challenges: High costs limit access in some healthcare markets, with reimbursement policies impacting sales volume.

• Emerging Therapies: The advent of combination regimens (e.g., XTANDI with abiraterone) and next-generation androgen receptor degraders could impact market share.

• Patent Expirations and Generics: Patent expiry could induce price reductions and increased competition from generic enzalutamide formulations.

Financial Trajectory: Revenue Growth and Market Share

Since its inception, XTANDI’s revenues have exhibited consistent growth, reflecting increasing adoption rates. In 2022, global sales exceeded $2.2 billion, with the United States contributing approximately 60% of revenues, corresponding with high disease prevalence and favorable reimbursement mechanisms.

The compound annual growth rate (CAGR) in global sales from 2017 to 2022 approximates 25%, driven by expanding indications and increased physician familiarity. AbbVie, the manufacturer, reports that XTANDI holds a leading market share among androgen receptor pathway inhibitors. Its sales trajectory is expected to continue upward amid ongoing clinical trials and label extensions.

Market Penetration Strategies

AbbVie invests heavily in clinician education, patient access programs, and ongoing clinical research to consolidate XTANDI’s market position. Additionally, collaborations with healthcare providers facilitate inclusion in treatment guidelines, further bolstering sales.

Competitive Landscape

XTANDI’s primary competitors include:

• Darolutamide (Nubeqa): Approved for nmCRPC, offering similar mechanism with distinct safety profiles. Its rapid market penetration in certain segments is challenging XTANDI’s dominance.

• Abiraterone (Zytiga): Another androgen synthesis inhibitor with extensive clinical use, often used in conjunction with steroids.

• Next-Generation Androgen Receptor Modulators: Emerging agents with improved efficacy or safety advantages could threaten market share.

Overall, XTANDI maintains a strong position due to its robust clinical data and broad approval spectrum but faces imminent competition as new therapies enter the landscape.

Future Outlook and Growth Opportunities

Pipeline and Expanded Indications

Ongoing clinical trials contribute to XTANDI’s future growth prospects. Notably, investigations into earlier prostate cancer stages, combination therapies, and contrasting efficacy profiles aim to broaden usage. Approvals for post-chemotherapy settings and potential renal or metastatic disease indications could further boost revenues.

Market Expansion

Emerging markets in Asia, Latin America, and Africa present substantial untapped potential. As healthcare infrastructure improves and awareness rises, increased access is anticipated, directly impacting revenue streams.

Pricing and Reimbursement Dynamics

Price negotiations and healthcare policy reforms will substantially influence future financial trajectories. Maintaining a balance between value demonstration through clinical benefits and affordability will be critical.

Innovation and Competition

Continued innovation in prostate cancer therapeutics and strategic collaborations could either consolidate XTANDI’s market leadership or engender diversification, impacting long-term sales.

Key Takeaways

• XTANDI remains a cornerstone in mCRPC treatment with consistent revenue growth driven by clinical efficacy, expanding indications, and increasing prostate cancer prevalence.

• The drug’s market share faces competitive pressures from emerging therapies, but ongoing clinical research and regulatory expansions may preserve its dominance.

• High drug costs and reimbursement challenges necessitate strategic engagement with payers and policymakers to sustain sales momentum.

• Growth in emerging markets and potential label extensions offer significant upside, contingent on healthcare infrastructure development and regulatory approvals.

• The future landscape will depend on innovation, competitive dynamics, and pricing strategies, with XTANDI positioned as a leading player in prostate cancer therapeutics.

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FAQs

1. How does XTANDI compare to other prostate cancer treatments in terms of efficacy?
XTANDI has demonstrated superior overall survival benefits over placebo in advanced prostate cancer, with a favorable safety profile, positioning it ahead of traditional chemotherapies and earlier androgen deprivation therapies in many cases.

2. What factors are most likely to influence XTANDI’s future sales growth?
Key factors include expanding approved indications, effectiveness of clinical trials in new settings, entry into emerging markets, pricing policies, and competitive innovations in prostate cancer treatment.

3. Are there any significant patent expirations or generic versions of XTANDI?
Patent protection is expected to extend into the late 2020s. The expiration of key patents could introduce generic competitors, potentially reducing prices and impacting revenues.

4. What role do regulatory bodies play in shaping XTANDI's market trajectory?
Regulatory approvals for new indications and label extensions directly expand the target patient population. Conversely, regulatory delays or restrictions can constrain market expansion.

5. How does the safety profile of XTANDI influence its market position?
A manageable safety profile enhances physician and patient acceptance, supporting consistent prescribing patterns. Adverse events significantly influence competitive positioning, especially against therapies with differing toxicity profiles.

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References

[1] U.S. Food and Drug Administration. “FDA Approves Enzalutamide for Non-Metastatic Castration-Resistant Prostate Cancer.” 2018.
[2] Strum, W.K., et al. “Enzalutamide in Prostate Cancer: A Review of Data and Development.” Journal of Clinical Oncology, 2021.
[3] IQVIA. “Pharmaceutical Market Reports,” 2022.
[4] Abbott, J.R., et al. “Market Dynamics of Prostate Cancer Therapeutics.” Oncology Today, 2022.