Flutamide - Generic Drug Details

What are the generic drug sources for flutamide and what is the scope of freedom to operate?

Flutamide is the generic ingredient in two branded drugs marketed by Schering, Actavis Labs Fl Inc, Chartwell Rx, Cipla, Pharmobedient, and Waylis Therap, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for flutamide. One supplier is listed for this compound.

Summary for flutamide

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	6
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	74
Patent Applications:	6,208
Drug Prices:	Drug price trends for flutamide
What excipients (inactive ingredients) are in flutamide?	flutamide excipients list
DailyMed Link:	flutamide at DailyMed

See drug prices for flutamide

Recent Clinical Trials for flutamide

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

Sponsor	Phase
Zhejiang Provincial People's Hospital	PHASE2
University of Colorado, Denver	Phase 4
Kafrelsheikh University	Phase 2

See all flutamide clinical trials

Pharmacology for flutamide

Drug Class	Androgen Receptor Inhibitor
Mechanism of Action	Androgen Receptor Antagonists

Medical Subject Heading (MeSH) Categories for flutamide

Androgen Antagonists

Antineoplastic Agents, Hormonal

Anatomical Therapeutic Chemical (ATC) Classes for flutamide

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

US Patents and Regulatory Information for flutamide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Schering	EULEXIN	flutamide	CAPSULE;ORAL	018554-001	Jan 27, 1989		DISCN	Yes	No
Cipla	FLUTAMIDE	flutamide	CAPSULE;ORAL	075780-001	Sep 19, 2001		DISCN	No	No
Waylis Therap	FLUTAMIDE	flutamide	CAPSULE;ORAL	075298-001	Sep 18, 2001		RX	No	Yes

Expired US Patents for flutamide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	EULEXIN	flutamide	CAPSULE;ORAL	018554-001	Jan 27, 1989
Schering	EULEXIN	flutamide	CAPSULE;ORAL	018554-001	Jan 27, 1989
Schering	EULEXIN	flutamide	CAPSULE;ORAL	018554-001	Jan 27, 1989

Flutamide Market Analysis and Financial Projection

Last updated: February 14, 2026

What Are the Market Dynamics for Flutamide?

Flutamide is a nonsteroidal antiandrogen primarily used in the treatment of prostate cancer, along with indications like male pattern baldness and certain hormone-related conditions. Its commercial viability is influenced by several market factors:

Competitive Landscape

The drug competes mainly with other antiandrogens, including bicalutamide, enzalutamide, and apalutamide. The latter two have gained popularity due to their superior efficacy profiles and safety data, especially in advanced prostate cancer treatments. Flutamide's market share has declined in regions favoring newer agents.

Regulatory Environment

Flutamide is off-patent in many regions, including the U.S. and Europe. The lack of patent protection limits exclusive rights, pressuring pricing power and market share. Regulatory agencies have approved flutamide since the 1980s, with updates focusing on safety data, particularly hepatotoxicity concerns.

Prescribing Patterns

Physicians prefer newer antiandrogens with better side-effect profiles, such as enzalutamide, especially for metastatic castration-resistant prostate cancer (mCRPC). Flutamide remains used in developing markets or as adjunct therapy where cost considerations outweigh the benefits of newer drugs.

Market Size and Growth

The global prostate cancer drug market was valued at approximately USD 8 billion in 2021 and is expected to grow at a compound annual growth rate (CAGR) of 8-10% through 2028. Flutamide accounts for a small fraction, estimated under 2%, primarily due to generic availability.

Pricing and Reimbursement

Generic status results in lower prices, roughly USD 10-30 per treatment course in many markets. Reimbursement policies vary; in some countries, subsidies support continued use in niche cases, while in others, payers favor newer, more expensive agents.

How Does the Financial Trajectory Look for Flutamide?

Revenue Trends

Since patent expiry, flutamide revenue has declined sharply. In 2010, the global sales totaled approximately USD 100 million. By 2022, estimates suggest sales are below USD 20 million yearly, mainly driven by emerging markets.

Growth Drivers and Challenges

The primary growth driver remains its low cost and established safety profile in specific regions. Challenges encompass competition from newer drugs with better tolerability, declining prescribing rates, and regulatory shifts favoring novel therapies.

Manufacturing and Cost Structure

Manufacturing costs are low due to its long-established synthesis process. As a generic product, profit margins are thin, approximating 10-15%. Companies may maintain production for revenue stabilization rather than growth.

Market Entry and Expansion

Most opportunities for flutamide involve niche applications, such as hormone therapy in resource-limited settings. More aggressive expansion into oncology or other indications faces scientific, regulatory, and marketing hurdles.

How Do the Regulatory and Patent Statuses Influence Market and Financial Outlook?

Flutamide’s patent expiry in the early 2000s led to widespread generic availability. The absence of patent protection restricts exclusive marketing rights, capping revenue potential. Any future regulatory updates would mostly involve safety monitoring rather than new indications, further limiting upside.

What Are Future Projections?

Market analysts forecast continued decline in flutamide revenues with small residual sales in developing regions. No significant pipeline developments or regulatory approvals are underway to revitalize the drug’s market presence. The overall outlook for flutamide is limited to niche applications and residual sales.

Key Takeaways

• Flutamide's original patent expired in the early 2000s; it is now a generic drug.
• Market share diminished due to competition from newer antiandrogens like enzalutamide and apalutamide.
• Estimated global sales declined from USD 100 million in 2010 to below USD 20 million in 2022.
• The drug has a low manufacturing cost and profit margins due to generic status.
• Growth in non-oncology indications is unlikely, given safety concerns and lack of new clinical development.

FAQs

1. What are the primary medical uses of flutamide?
Treatment of prostate cancer, hormone-related disorders, and off-label use in conditions like male pattern baldness.

2. How does flutamide compare with newer antiandrogens?
It has a less favorable safety profile, particularly with hepatotoxicity, and inferior efficacy in advanced prostate cancer.

3. What is the patent status of flutamide?
Patents expired in the early 2000s, making it a generic drug.

4. Why has flutamide's market share declined?
Because of competition from newer agents with improved efficacy and safety profiles.

5. What is the future outlook for flutamide?
It is expected to see continued decline in sales, remaining primarily in niche markets with low growth potential.

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Citations
[1] MarketWatch. "Prostate Cancer Drug Market Size, Trends and Forecasts," 2022.
[2] FDA Label. Flutamide, 2022.
[3] IMS Health. "Generic Oncology Drugs," 2021.