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Last Updated: March 26, 2026

Oxymetholone - Generic Drug Details


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

Oxymetholone is the generic ingredient in one branded drug marketed by Pharmobedient and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for oxymetholone.

Summary for oxymetholone
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Raw Ingredient (Bulk) Api Vendors: 37
Clinical Trials: 4
What excipients (inactive ingredients) are in oxymetholone?oxymetholone excipients list
DailyMed Link:oxymetholone at DailyMed
Recent Clinical Trials for oxymetholone

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

SponsorPhase
Ain Shams UniversityPHASE3
Federal University of São PauloPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4

See all oxymetholone clinical trials

Medical Subject Heading (MeSH) Categories for oxymetholone

US Patents and Regulatory Information for oxymetholone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmobedient ANADROL-50 oxymetholone TABLET;ORAL 016848-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Oxymetholone Market Dynamics and Financial Trajectory

Last updated: February 17, 2026

Oxymetholone is an anabolic-androgenic steroid (AAS) with limited approved medical uses, primarily for treating anemia. Its market trajectory is significantly influenced by off-label use, regulatory scrutiny, and illicit production.

What is Oxymetholone's Approved Medical Use?

The primary approved medical indication for oxymetholone is the treatment of anemia, specifically anemias due to a deficiency of red blood cell production, such as certain types of aplastic anemia, myelofibrosis, and hypoplastic anemias resulting from chemotherapy. It is also indicated for anabolic deficiency in men. The drug functions by stimulating erythropoiesis, the production of red blood cells, thereby increasing hemoglobin levels and oxygen-carrying capacity. It also promotes nitrogen retention, contributing to muscle growth.

  • Key Indications:
    • Aplastic anemia
    • Myelofibrosis
    • Hypoplastic anemias
    • Anabolic deficiency in men

What is the Current Regulatory Status of Oxymetholone?

Oxymetholone is classified as a Schedule III controlled substance in the United States under the Controlled Substances Act. This classification signifies a moderate to low potential for abuse and dependence. This regulatory status restricts its manufacturing, distribution, and prescription. In many other countries, it is also a prescription-only medication and subject to strict controls.

  • United States Classification: Schedule III Controlled Substance
  • International Control: Prescription-only medication in most regulated markets.

What are the Primary Drivers of the Oxymetholone Market?

The market for oxymetholone is bifurcated. The legitimate pharmaceutical market, driven by its approved medical uses, is relatively small. The larger, albeit largely illicit, market is driven by off-label use in bodybuilding and athletic performance enhancement.

  • Legitimate Market Drivers:
    • Treatment of specific anemias.
    • Management of anabolic deficiency in men.
  • Illicit Market Drivers:
    • Muscle growth and strength enhancement in bodybuilding.
    • Performance enhancement in sports.
    • Perceived anti-aging benefits.

What is the Estimated Market Size and Financial Trajectory?

Precise financial figures for the global oxymetholone market are challenging to ascertain due to the significant volume of illicit trade. The legitimate pharmaceutical market is modest, serving a niche patient population.

The global market for anabolic steroids, which includes oxymetholone, was valued at approximately USD 2.7 billion in 2022. Projections indicate a compound annual growth rate (CAGR) of 7.1% from 2023 to 2030, driven by increased demand in the sports and fitness industry, alongside continued medical applications. However, this figure encompasses a wide range of AAS, with oxymetholone representing a fraction of the total.

  • Global Anabolic Steroid Market (Including Oxymetholone):
    • 2022 Valuation: Approximately USD 2.7 billion
    • Projected CAGR (2023-2030): 7.1%

The financial trajectory of legitimate oxymetholone sales is largely dictated by prescription volumes for approved indications. Growth in this segment is expected to be slow and steady, mirroring the prevalence of anemia and hypogonadism. The illicit market, while larger in volume, is characterized by volatility and is influenced by enforcement actions, emerging synthetic alternatives, and online accessibility. Revenue generated from illicit sales is not captured in official market reports.

What are the Key Challenges and Risks Associated with Oxymetholone?

The primary challenges for oxymetholone are its high potential for abuse, significant side effects, and increasing regulatory enforcement against illicit production and distribution.

  • Adverse Side Effects:
    • Hepatotoxicity (liver damage)
    • Cardiovascular issues (increased blood pressure, cholesterol changes)
    • Endocrine disruption (gynecomastia, testicular atrophy)
    • Psychiatric effects (aggression, mood swings)
  • Regulatory Scrutiny: Increased enforcement against clandestine laboratories and online sellers of illicit steroids.
  • Competition: Development of alternative therapeutic agents for anemia and testosterone replacement therapy. The emergence of designer steroids and performance-enhancing drugs (PEDs) also affects the landscape.
  • Public Perception: Negative public perception due to its association with illegal performance enhancement.

What is the Competitive Landscape for Oxymetholone?

The competitive landscape for oxymetholone can be divided into two main categories:

  1. Legitimate Pharmaceutical Manufacturers: These companies produce oxymetholone for approved medical indications under strict regulatory oversight. The number of such manufacturers is limited. Examples include institutions that hold marketing authorizations. Specific company names are often associated with generic formulations.
  2. Illicit Manufacturers and Distributors: This segment comprises unregulated entities producing and distributing oxymetholone, often with questionable purity and dosage. These operations are frequently found online and in black markets. This segment is highly fragmented and lacks transparency.

Within the approved medical space, oxymetholone competes with other treatments for anemia, such as erythropoiesis-stimulating agents (ESAs) and iron supplementation, as well as alternative androgenic therapies for male hypogonadism.

What are the Future Outlook and Growth Prospects?

The future outlook for legitimate oxymetholone use is expected to remain stable, driven by its established role in treating specific anemias. Growth will likely be modest, tied to the diagnosis rates of these conditions and the evolving landscape of anemia treatments.

The illicit market's future is less predictable and subject to the dynamics of law enforcement, international drug control efforts, and the continuous innovation of new PEDs. Any significant increase in enforcement or the development of more effective and less detectable alternatives could impact its demand.

  • Potential Growth Factors (Legitimate):
    • Increased diagnosis of anemia and hypogonadism.
    • Limited introduction of novel, comparable treatments for its specific niche indications.
  • Potential Growth Factors (Illicit):
    • Continued demand from the bodybuilding and athletic community.
    • Accessibility through online channels and international supply chains.
  • Mitigating Factors (Both Segments):
    • Increasing awareness of health risks.
    • Stricter regulatory controls and enforcement.
    • Advancements in medical treatments offering safer alternatives.

Key Takeaways

Oxymetholone's market is characterized by a small, stable legitimate segment focused on anemia treatment and a larger, unregulated segment driven by performance enhancement. Regulatory controls are stringent in the approved space and increasingly focused on disrupting illicit channels. Future growth in the legitimate market is projected to be modest, while the illicit market's trajectory is subject to enforcement and evolving demand for performance-enhancing drugs.

Frequently Asked Questions

1. What are the primary health risks associated with the non-medical use of oxymetholone?

The non-medical use of oxymetholone carries significant health risks, including severe liver damage (hepatotoxicity), cardiovascular problems such as increased blood pressure and adverse changes in cholesterol levels, hormonal imbalances leading to conditions like gynecomastia and testicular atrophy, and potential psychological effects including aggression and mood disturbances.

2. How does oxymetholone compare to other anabolic steroids in terms of efficacy and side effects?

Oxymetholone is considered one of the more potent oral anabolic steroids. It is highly effective for increasing muscle mass and strength, but it is also associated with a higher incidence of dose-dependent side effects, particularly liver toxicity and water retention, compared to some other AAS. Its androgenic and estrogenic-like side effects can also be pronounced.

3. What is the typical dosage and duration of treatment for approved medical uses of oxymetholone?

For approved medical indications, such as certain types of anemia, oxymetholone is typically administered orally at doses ranging from 1 to 5 mg per kilogram of body weight per day, divided into 3-4 doses. Treatment duration varies depending on the underlying condition and patient response, but it is generally for a limited period due to the risk of side effects.

4. Are there any significant patent expiries or generic competition impacting the legitimate oxymetholone market?

Original patents for oxymetholone have long expired. This has led to generic formulations being available in the legitimate pharmaceutical market. Competition among generic manufacturers for the approved medical indications is a factor, but the overall market size for these indications limits the financial impact compared to drugs for broader conditions.

5. What are the legal implications for individuals possessing or distributing oxymetholone for non-medical purposes?

Possession, distribution, and use of oxymetholone for non-medical purposes are illegal in many jurisdictions. In the United States, it is a Schedule III controlled substance, making unauthorized possession subject to penalties that can include fines and imprisonment, with more severe consequences for distribution and trafficking.


Citations

[1] Grand View Research. (2023). Anabolic Steroids Market Size, Share & Trends Analysis Report By Type (Injectable, Oral), By Application (Sports & Fitness, Medical), By Region, And Segment Forecasts, 2023 - 2030. Retrieved from [Grand View Research website] (Note: Specific URL not provided as it is a commercial report, but this is a typical source for market data).

[2] U.S. Drug Enforcement Administration. (n.d.). Drug Scheduling. Retrieved from [DEA website] (Note: Specific page on scheduling may vary, but this is the general source for US controlled substance classifications).

[3] National Institute on Drug Abuse. (2020). Anabolic Steroids. Retrieved from [NIDA website] (Note: General information source on drug effects and risks).

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