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Last Updated: January 14, 2025

Flutamide - Generic Drug Details


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Summary for flutamide
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Recent Clinical Trials for flutamide

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SponsorPhase
University of Colorado, DenverPhase 4
Kafrelsheikh UniversityPhase 2
2-Montefiore Health System and Albert Einstein College of Medicine, Newyork, United States of America (U.S.A).Phase 3

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Medical Subject Heading (MeSH) Categories for flutamide

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

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 ⤷  Subscribe
Schering EULEXIN flutamide CAPSULE;ORAL 018554-001 Jan 27, 1989 4,472,382 ⤷  Subscribe
Schering EULEXIN flutamide CAPSULE;ORAL 018554-001 Jan 27, 1989 5,712,251 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Flutamide Market Analysis and Financial Projection

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.

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