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, Norvium Bioscience, 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:	130
Clinical Trials:	72
Patent Applications:	7,486
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
University of Colorado, Denver	Phase 4
Kafrelsheikh University	Phase 2
1-Foshan University Laboratory of Emerging Infectious Disease Institute of Translational Medicine The First Hospital of Jilin University China	Phase 3

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
Waylis Therap	FLUTAMIDE	flutamide	CAPSULE;ORAL	075298-001	Sep 18, 2001		RX	No	Yes
Actavis Labs Fl Inc	FLUTAMIDE	flutamide	CAPSULE;ORAL	075820-001	Sep 18, 2001		DISCN	No	No
Chartwell Rx	FLUTAMIDE	flutamide	CAPSULE;ORAL	075818-001	Sep 18, 2001		DISCN	No	No
Schering	EULEXIN	flutamide	CAPSULE;ORAL	018554-001	Jan 27, 1989		DISCN	Yes	No
Norvium Bioscience	FLUTAMIDE	flutamide	CAPSULE;ORAL	076224-001	May 9, 2003		DISCN	No	No
Cipla	FLUTAMIDE	flutamide	CAPSULE;ORAL	075780-001	Sep 19, 2001		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	4,329,364
Schering	EULEXIN	flutamide	CAPSULE;ORAL	018554-001	Jan 27, 1989	4,472,382
Schering	EULEXIN	flutamide	CAPSULE;ORAL	018554-001	Jan 27, 1989	5,712,251

FLUTAMIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Flutamide

Introduction

Flutamide, a small molecule drug developed by Schering-Plough Corp., has been a cornerstone in the treatment of prostatic cancer since its approval in the United States in 1989. Here, we delve into the market dynamics and financial trajectory of flutamide, exploring its development, clinical applications, competitive landscape, and market trends.

Development and Approval

Flutamide was first approved by the FDA in January 1989 and has since been approved globally for the treatment of prostatic cancer. It is an androgen receptor antagonist, designed to interact with the androgen receptor to inhibit the growth and spread of cancer cells in the prostate gland[1].

Clinical Applications

Flutamide is primarily used in the treatment of prostate cancer, particularly in non-metastatic castration-resistant prostate cancer (nmCRPC). It has been used both as a standalone treatment and in combination with other therapies, such as the PROSTVAC vaccine, although recent studies suggest that such combinations may not offer significant clinical benefits over flutamide alone[2].

Mechanism of Action

Flutamide works by blocking the androgen receptor, a protein crucial for the development and functioning of male reproductive tissues and the growth of certain types of cancer, including prostate cancer. By inhibiting this receptor, flutamide reduces the influence of androgens on cancer cells, thereby slowing down the progression of the disease[1].

Competitive Landscape

The market for androgen receptor antagonists, such as flutamide, is highly competitive. Several pharmaceutical companies, including Bayer AG, Pfizer Inc., Suzhou Kintor Pharmaceuticals, Inc., and Johnson & Johnson, are actively involved in the development of drugs targeting the androgen receptor. This competition is driven by the significant clinical applications of AR antagonists in treating prostate cancer, hypogonadism, breast cancer, and other androgen-related conditions[1].

Market Trends

The flutamide market is expected to grow, driven by increasing demand for effective treatments for prostate cancer. The market is projected to rise at a CAGR of XX% from 2023 to 2031, reflecting the ongoing need for androgen receptor antagonists in clinical practice[4].

Financial Aspects

The financial trajectory of flutamide is influenced by several factors, including market competition, regulatory approvals, and the emergence of next-generation anti-androgens. Despite being a first-generation anti-androgen, flutamide remains a valuable therapeutic option due to its established track record and global approvals.

Generic Market Impact

The generic market plays a significant role in the financial dynamics of flutamide. Generic versions of flutamide, such as those produced by Teva and other generic drug manufacturers, have been subject to antitrust regulations to ensure market competition. For instance, the FTC has required divestitures in markets where mergers could reduce competition, including the market for flutamide capsules[3].

Revenue and Sales

While specific revenue figures for flutamide are not readily available, the drug's long-standing presence and global approvals indicate a stable revenue stream. The market for AR antagonists, including flutamide, is substantial, with numerous clinical trials and ongoing research and development activities contributing to its financial viability.

Regional Market Dynamics

The development and marketing of flutamide vary by region, with the United States, China, and the European Union being key markets. China has shown significant progress in drug development for the androgen receptor target, indicating a growing market potential in this region[1].

Challenges and Opportunities

Despite its established position, flutamide faces challenges from next-generation anti-androgens that have demonstrated better survival benefits in clinical trials. However, flutamide's well-tolerated profile and extensive clinical experience make it a reliable option for many patients. The ongoing research and development in the AR antagonist space present opportunities for flutamide to remain relevant through combination therapies or new formulations.

Conclusion

Flutamide's market dynamics are characterized by its long-standing presence, competitive landscape, and ongoing clinical applications. Despite the emergence of next-generation anti-androgens, flutamide remains a valuable therapeutic option for prostate cancer treatment. The financial trajectory of flutamide is influenced by its global approvals, generic market competition, and regional market dynamics.

Key Takeaways

• Established Track Record: Flutamide has been approved globally since 1989 and is widely recognized for its efficacy in treating prostate cancer.
• Competitive Landscape: The market for AR antagonists is highly competitive, with several pharmaceutical companies involved in R&D.
• Market Growth: The flutamide market is expected to grow, driven by increasing demand for effective prostate cancer treatments.
• Generic Market Impact: Generic versions of flutamide are subject to antitrust regulations to maintain market competition.
• Regional Dynamics: The United States, China, and the European Union are key markets for flutamide.

FAQs

Q: What is the primary use of flutamide? A: Flutamide is primarily used for the treatment of prostatic cancer by targeting the androgen receptor.

Q: When was flutamide first approved? A: Flutamide was first approved by the FDA in January 1989.

Q: How does flutamide work? A: Flutamide works by blocking the androgen receptor, thereby inhibiting the growth and spread of prostate cancer cells.

Q: What are the key competitors in the AR antagonist market? A: Key competitors include Bayer AG, Pfizer Inc., Suzhou Kintor Pharmaceuticals, Inc., and Johnson & Johnson.

Q: What is the projected market growth for flutamide? A: The flutamide market is expected to rise at a CAGR of XX% from 2023 to 2031.

Sources

1. Patsnap Synapse: An In-depth Analysis of Flutamide's R&D Progress and Mechanism of Action on Drug Target.
2. Oxford Academic: Flutamide With or Without PROSTVAC in Non-metastatic Castration-Resistant Prostate Cancer.
3. Wilson Sonsini: Antitrust Health Care Chronicle - February 2009.
4. The Insight Partners: Flutamide Market Strategies and Share 2031.
5. Cayman Chemical: PRODUCT INFORMATION - Flutamide.