FLUTAMIDE - Generic Drug Details

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

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. Two suppliers are 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:	2
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
Chartwell Rx	FLUTAMIDE	flutamide	CAPSULE;ORAL	075818-001	Sep 18, 2001		DISCN	No	No
Cipla	FLUTAMIDE	flutamide	CAPSULE;ORAL	075780-001	Sep 19, 2001		DISCN	No	No
Pharmobedient	FLUTAMIDE	flutamide	CAPSULE;ORAL	076224-001	May 9, 2003		DISCN	No	No

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

Market Dynamics and Financial Trajectory for Flutamide: An Industry Analysis

Last updated: July 28, 2025

Introduction

Flutamide, a non-steroidal anti-androgen agent, is primarily employed in the treatment of prostate cancer and androgen-dependent disorders. Since its regulatory approval, the drug’s market performance has been influenced by evolving clinical guidelines, competitive innovations, patent statuses, and shifting healthcare policies. This analysis offers a comprehensive review of the current market dynamics and forecasts the financial trajectory of flutamide within the pharmaceutical landscape.

Market Overview and Therapeutic Positioning

Introduced in the 1980s, flutamide gained prominence as an adjunct therapy in androgen deprivation for prostate cancer, a condition affecting approximately 1.3 million men globally (WHO, 2021). Its mechanism involves blocking androgen receptors, thereby inhibiting tumor growth. The drug’s long-standing use, however, faces competition from newer anti-androgens like enzalutamide and apalutamide, which offer improved efficacy and better side-effect profiles.

The demand for flutamide is closely tied to prostate cancer prevalence and the adoption of hormonal management strategies. Its positioning is further influenced by emerging therapies and clinical guidelines favoring agents with superior safety or convenience profiles.

Market Dynamics Influencing Flutamide

1. Competitive Landscape and Innovation

The pharmaceutical market for androgen deprivation therapy (ADT) has become increasingly competitive. While flutamide remains a cost-effective option, clinicians often prefer newer agents such as enzalutamide and abiraterone due to their improved survival benefits and tolerability (Clinical Oncology, 2022). Nonetheless, flutamide maintains a niche, particularly in resource-limited settings where cost considerations overshadow marginal clinical benefits.

2. Patent Expiry and Generic Availability

Most formulations of flutamide are off-patent, fostering a thriving generic market that drives down prices and enhances accessibility—especially in developing regions. The proliferation of generics intensifies price competition but limits revenue potential for originators, creating a pressurized market environment. Some patent protections for specific formulations or delivery methods may still exist, providing incremental revenue streams.

3. Regulatory and Clinical Guidelines

Evolving clinical guidelines favor multi-modal treatment approaches, sometimes relegating flutamide in favor of agents with demonstrated longer-term survival benefits. Regulatory bodies such as the FDA and EMA continually assess the drug’s safety profile; adverse effects like hepatotoxicity and gastrointestinal disturbances impact prescribing patterns.

4. Geographic and Demographic Factors

In high-income countries, the adoption of newer therapies is more rapid due to robust healthcare infrastructure, contrasting with developing markets where affordability remains paramount. As such, flutamide retains importance in regions where healthcare resources are constrained, maintaining a steady albeit declining demand.

5. Pricing and Reimbursement Policies

In markets with robust reimbursement systems, formularies often favor more expensive agents backed by extensive clinical data. Conversely, in cost-sensitive markets, flutamide’s low price grants it sustained market presence. Pricing strategies are influenced by government policies, insurance coverage, and competition from generics.

Financial Trajectory: Revenue Trends and Forecasts

Historical Revenue Performance

Historically, flutamide generated peak revenues during the late 1990s and early 2000s when prostate cancer therapies were less advanced. Global sales, however, declined steadily as newer agents gained dominance. In 2020, global sales are estimated to be approximately $200 million, predominantly driven by emerging markets and generic distribution (IQVIA, 2021).

Forecasted Growth and Decline

Analysts project a continued decline in flutamide revenues over the next five years, at a compounded annual growth rate (CAGR) of approximately -4% (Research and Markets, 2022). The decline will be primarily driven by:

• Increasing adoption of next-generation anti-androgens
• Stricter safety profiles limiting use in certain populations
• Patent and formulation expiries facilitating generic commoditization

However, in resource-limited markets, the demand may stabilize or slightly grow, supporting a steady baseline revenue. Additionally, the introduction of novel formulations or combination therapies incorporating flutamide could present niche opportunities.

Impact of Emerging Therapeutics and Biosimilars

The rise of androgen receptor inhibitors with superior efficacy gradually eclipses flutamide’s market share. Biosimilar competition, especially in developing countries, further depresses prices and margins. Nevertheless, this commoditization sustains supply chains, ensuring ongoing, albeit diminished, revenue streams.

Regulatory Considerations and Market Access

Price regulations and healthcare reforms, particularly in countries like India, China, and Brazil, impact profitability. A trend towards stricter cost-effectiveness assessments diminishes profitability margins for older drugs like flutamide. Conversely, advocacy for affordable cancer treatments sustains demand in low-income regions.

Strategic Outlook and Market Opportunities

While the overarching trend forecasts a decline, opportunities remain in niche markets and combination therapies. Developing countries’ expanding oncology infrastructure may sustain flutamide’s relevance in specific contexts. Additionally, research into new formulations or combination regimens could revitalize its market segment.

Furthermore, patent pursuits or new indications could temporarily buoy revenues. Collaborations with generic manufacturers and strategic pricing can optimize profitability amid fierce competition.

Conclusion

Flutamide’s market dynamics reflect the broader evolution of prostate cancer treatment paradigms. The drug faces steady decline in high-income markets due to technological advancements and stringent safety profiles, leading to a negative financial trajectory forecasted over the next five years. Conversely, its role in resource-constrained settings and niche indications sustains modest demand. Its future hinges on adapting to competitive pressures, regulatory landscapes, and emerging needs within global oncology.

Key Takeaways

• Declining Revenue: Flutamide’s global sales are anticipated to decrease at a CAGR of approximately -4% over the next five years due to competition from advanced anti-androgens.
• Market Segmentation: It retains importance mainly in low-income and resource-limited regions where cost considerations dominate physician prescribing habits.
• Competitive Pressures: Introduction of newer, more effective agents with better safety profiles accelerates market obsolescence.
• Pricing and Generics: The off-patent status facilitates widespread generic manufacturing, compressing margins but enhancing access.
• Niche Opportunities: Development of combination therapies or novel formulations may provide incremental revenue streams, especially in emerging markets.

FAQs

1. What are the main competitors of flutamide in prostate cancer therapy?
   Enzalutamide, apalutamide, and abiraterone acetate are leading competitors offering enhanced efficacy and safety profiles.

2. How does patent expiry influence flutamide’s market?
   Patent expiry results in a surge of generic versions, lowering prices and increasing accessibility but reducing profitability for originators.

3. What safety concerns impact flutamide’s clinical use?
   Hepatotoxicity and gastrointestinal adverse effects can limit long-term use, especially when safer alternatives are available.

4. Is there any resurgence potential for flutamide?
   Limited; niche roles in resource-limited settings or in combination with emerging therapies could sustain modest demand.

5. Which markets are driving the continued use of flutamide?
   Developing countries such as India, Brazil, and some Southeast Asian nations continue to rely on flutamide due to affordability and established treatment protocols.

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Sources:
[1] World Health Organization (WHO), Global Prostate Cancer Data, 2021.
[2] Clinical Oncology Journal, 2022.
[3] IQVIA, Market Analysis Reports, 2021.
[4] Research and Markets, Oncology Therapeutics Market Report, 2022.