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Last Updated: December 22, 2024

Fluoxymesterone - Generic Drug Details


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Summary for fluoxymesterone
US Patents:0
Tradenames:4
Applicants:5
NDAs:8
Drug Master File Entries: 3
Raw Ingredient (Bulk) Api Vendors: 48
Clinical Trials: 2
Patent Applications: 6,885
Drug Prices: Drug price trends for fluoxymesterone
What excipients (inactive ingredients) are in fluoxymesterone?fluoxymesterone excipients list
DailyMed Link:fluoxymesterone at DailyMed
Drug Prices for fluoxymesterone

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Recent Clinical Trials for fluoxymesterone

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

SponsorPhase
Federal University of São PauloPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4
ASCEND TherapeuticsPhase 2

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Medical Subject Heading (MeSH) Categories for fluoxymesterone

US Patents and Regulatory Information for fluoxymesterone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs FLUOXYMESTERONE fluoxymesterone TABLET;ORAL 088260-001 Dec 6, 1983 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs FLUOXYMESTERONE fluoxymesterone TABLET;ORAL 088265-001 Dec 6, 1983 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Valeant Pharm Intl ANDROID-F fluoxymesterone TABLET;ORAL 087196-001 Approved Prior to Jan 1, 1982 DISCN No 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

Fluoxymesterone Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fluoxymesterone

Introduction

Fluoxymesterone, known by brand names such as Halotestin and Androxy, is a synthetic androgenic anabolic steroid with a diverse range of medical and non-medical uses. This article delves into the market dynamics and financial trajectory of fluoxymesterone, exploring its medical applications, market trends, and the economic factors influencing its use.

Medical Uses and Indications

Fluoxymesterone is approved for the treatment of several medical conditions, including hypogonadism and delayed puberty in males, and breast neoplasms in women. It is also used to treat anemia in some cases[1][4].

Hypogonadism and Delayed Puberty

In males, fluoxymesterone is used to treat conditions associated with low testosterone levels, such as hypogonadism and delayed puberty. Its androgenic properties help in promoting masculinization and addressing the symptoms of these conditions.

Breast Cancer

In women, fluoxymesterone is utilized in the treatment of breast cancer, particularly estrogen receptor-positive breast cancer. Its mechanism involves the inhibition of estrogen receptors, which can help in reducing tumor growth[1][4].

Market Trends

The market for fluoxymesterone is influenced by several factors, including its medical indications, non-medical use, and regulatory status.

Medical Market

The demand for fluoxymesterone in the medical sector is driven by its approved indications. However, its use is often limited by the availability of alternative treatments and the specific patient populations it targets. For instance, in the treatment of hypogonadism, other testosterone replacement therapies may be preferred due to their broader range of formulations and delivery methods[4].

Non-Medical Use

Fluoxymesterone is also used non-medically by athletes and bodybuilders to enhance performance and physique. This illicit use contributes significantly to its market demand but is heavily regulated and often illegal in many countries. The black market for anabolic steroids, including fluoxymesterone, poses significant challenges for manufacturers and regulatory bodies[5].

Regulatory Environment

The regulatory environment plays a crucial role in shaping the market dynamics of fluoxymesterone.

Controlled Substance Status

Fluoxymesterone is classified as a controlled substance in many countries due to its potential for abuse and side effects. This classification restricts its distribution and use, impacting both medical and non-medical markets[4].

Compliance and Enforcement

Regulatory bodies enforce strict guidelines on the prescription, distribution, and use of fluoxymesterone. Compliance with these regulations is essential for manufacturers and healthcare providers to avoid legal repercussions.

Financial Trajectory

The financial performance of fluoxymesterone is influenced by several factors, including its pricing, market demand, and competition.

Pricing

The pricing of fluoxymesterone varies based on the dosage form and the region. For example, the cost of fluoxymesterone tablets can range from $11.35 per 10 mg capsule to higher costs for bulk purchases of the powder form[1].

Market Demand

The demand for fluoxymesterone is relatively stable in the medical sector due to its specific indications. However, the non-medical demand can fluctuate based on trends in the bodybuilding and athletic communities.

Competition

Fluoxymesterone faces competition from other anabolic steroids and testosterone replacement therapies. The choice of treatment often depends on the specific needs of the patient and the preferences of healthcare providers.

Economic Impact

The economic impact of fluoxymesterone extends beyond its direct sales to include broader healthcare and societal costs.

Healthcare Costs

The use of fluoxymesterone can result in significant healthcare costs due to its side effects, such as liver damage and cardiovascular issues. These costs include hospitalizations, additional treatments, and long-term care[4].

Societal Costs

The non-medical use of fluoxymesterone contributes to societal costs related to public health, law enforcement, and social services. The abuse of anabolic steroids is associated with high-risk behaviors, mental health issues, and other social problems[5].

Manufacturer and Distribution Dynamics

Several manufacturers are involved in the production and distribution of fluoxymesterone, each with their own market strategies.

Major Manufacturers

Companies such as Major Pharmaceuticals, Qualitest, Spectrum Pharmaceuticals, and Valeant Ltd. are among the key manufacturers of fluoxymesterone. These companies play a crucial role in ensuring the drug's availability and compliance with regulatory standards[1].

Distribution Channels

Fluoxymesterone is distributed through various channels, including pharmacies, hospitals, and online platforms. The distribution network must adhere to strict regulatory guidelines to prevent diversion and misuse.

Future Outlook

The future outlook for fluoxymesterone is influenced by ongoing research, regulatory changes, and shifts in market demand.

Research and Development

Ongoing research into the pharmacological properties of fluoxymesterone and its potential new indications could expand its medical use. For example, studies on its antitumor activity and its role in inhibiting 11β-hydroxysteroid dehydrogenase type 2 (11β-HSD2) may open new therapeutic avenues[1][4].

Regulatory Changes

Changes in regulatory policies, such as stricter controls on anabolic steroids or new guidelines for their medical use, can significantly impact the market dynamics of fluoxymesterone.

Market Demand Shifts

Shifts in market demand, driven by changes in healthcare practices or trends in the bodybuilding and athletic communities, will continue to influence the financial trajectory of fluoxymesterone.

Key Takeaways

  • Fluoxymesterone is a synthetic androgenic anabolic steroid used in treating hypogonadism, delayed puberty, and breast cancer.
  • Its market is influenced by medical indications, non-medical use, and regulatory status.
  • The drug is classified as a controlled substance, affecting its distribution and use.
  • Economic factors include pricing, market demand, competition, and broader healthcare and societal costs.
  • Manufacturers and distribution channels must comply with strict regulatory guidelines.
  • The future outlook is shaped by ongoing research, regulatory changes, and shifts in market demand.

FAQs

What are the primary medical uses of fluoxymesterone?

Fluoxymesterone is primarily used in the treatment of hypogonadism and delayed puberty in males, and breast neoplasms in women. It is also used to treat anemia in some cases.

Why is fluoxymesterone classified as a controlled substance?

Fluoxymesterone is classified as a controlled substance due to its potential for abuse and its side effects, which include liver damage and cardiovascular issues.

What are the common side effects of fluoxymesterone?

Common side effects include symptoms of masculinization such as acne, increased hair growth, voice changes, and increased sexual desire. It can also cause liver damage and cardiovascular side effects like high blood pressure.

How does fluoxymesterone affect testosterone levels?

Fluoxymesterone administration is associated with a significant suppression of testosterone levels. This effect is seen within 24 hours of starting the treatment and continues throughout the treatment period[3].

What is the impact of fluoxymesterone on the liver?

Fluoxymesterone is known to be hepatotoxic, meaning it can cause liver damage. This is due to its 17α-methyl group, which impedes its metabolism and makes it orally active but also increases its risk of liver toxicity[4].

Sources

  1. DrugBank: Fluoxymesterone: Uses, Interactions, Mechanism of Action.
  2. ScienceDirect: A Value of Information Analysis of CYP2D6 Testing to Guide Breast Cancer Treatment.
  3. PubMed: The effects of fluoxymesterone administration on testicular function.
  4. Wikipedia: Fluoxymesterone.
  5. Wiley Online Library: The injecting use of image and performance-enhancing drugs.

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