OXYMETHOLONE - Generic Drug Details

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.

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

Sponsor	Phase
Ain Shams University	PHASE3
Federal University of São Paulo	Phase 4
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4

See all OXYMETHOLONE clinical trials

Medical Subject Heading (MeSH) Categories for OXYMETHOLONE

Anabolic Agents

Androgens

Anatomical Therapeutic Chemical (ATC) Classes for OXYMETHOLONE

A14AA	Androstan derivatives
A14A	ANABOLIC STEROIDS
A14	ANABOLIC AGENTS FOR SYSTEMIC USE
A	Alimentary tract and metabolism

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

Oxymetholone Market Dynamics, Patent Status, FDA Regulation, and Financial Trajectory

Last updated: September 5, 2026

Oxymetholone is a mature oral anabolic-androgenic steroid marketed primarily for severe anemia, including acquired aplastic anemia, myelofibrosis, and hypoplastic anemia associated with myelotoxic treatment. The U.S. market is genericized, small, and medically specialized. Its commercial value depends more on continued manufacturing, controlled-substance compliance, and intermittent supply constraints than on patent exclusivity.

No active composition-of-matter patent, regulatory exclusivity period, or material Orange Book patent barrier protects oxymetholone in the United States. Public companies do not separately report oxymetholone revenue, preventing a reliable product-level sales estimate. The financial trajectory is consistent with a low-volume mature generic: limited pricing power under normal supply conditions, but potential price volatility when few suppliers manufacture the product.

What is oxymetholone and how is it used?

Oxymetholone is a synthetic testosterone derivative administered as an oral tablet. The U.S. reference product is commonly associated with Anadrol-50, a 50-mg tablet. The FDA label identifies the drug for treatment of anemias caused by deficient red-cell production, including acquired aplastic anemia, myelofibrosis, and hypoplastic anemia resulting from myelotoxic drugs [1].

Oxymetholone is not an erythropoiesis-stimulating agent. It is an androgen that can increase erythropoietic activity, although its mechanism is not fully established in the FDA labeling. Treatment requires monitoring of blood counts, liver function, lipid parameters, and signs of androgenic adverse effects.

What are the main clinical demand drivers?

Demand comes from a narrow group of hematology patients:

• Acquired aplastic anemia and related marrow-failure syndromes.
• Myelofibrosis-associated anemia in selected treatment settings.
• Hypoplastic anemia associated with myelotoxic drugs.
• Specialist and hospital use when newer therapies are unsuitable, unavailable, or not tolerated.

Oxymetholone competes with supportive transfusions, immunosuppressive therapy, hematopoietic stem-cell transplantation, erythropoiesis-stimulating agents, danazol, and newer agents used in myelofibrosis or aplastic anemia. Standard treatment for severe aplastic anemia has increasingly centered on antithymocyte globulin, cyclosporine, eltrombopag, and transplantation rather than androgen monotherapy [2, 3].

How large is the oxymetholone market?

The addressable market is limited by three factors: a narrow FDA-approved population, substitution by newer therapies, and the drug’s adverse-effect profile. Public financial filings generally do not disclose oxymetholone sales separately because manufacturers report it within broader generic or specialty-pharmaceutical portfolios.

Market characteristic	Oxymetholone assessment
Product type	Mature oral small-molecule generic
U.S. reference product	Anadrol-50
Strength commonly marketed	50 mg tablet
Primary prescribers	Hematologists and hospital specialists
Primary approved use	Severe anemia caused by deficient red-cell production
Regulatory status	FDA-approved prescription drug
Controlled-substance status	Schedule III anabolic steroid under federal law [4]
Biosimilar exposure	None
Patent-driven pricing power	Minimal
Public product-level revenue	Not separately disclosed
Main commercial risks	Supplier concentration, compliance costs, clinical substitution, supply interruption

The legitimate market should not be conflated with nonmedical use. Oxymetholone is associated with bodybuilding and performance-enhancing use, but that demand is outside the approved pharmaceutical market and creates legal, regulatory, safety, and reputational risks for manufacturers and distributors.

When does oxymetholone lose exclusivity?

Oxymetholone lost meaningful market exclusivity decades ago. The active ingredient was introduced before the modern Hatch-Waxman framework, and any original composition-of-matter or product patents would have expired long before the current generic market.

The commercial exclusivity timeline is therefore best characterized as follows:

Milestone	Status
Original approval era	Pre-Hatch-Waxman product
New chemical entity exclusivity	Not relevant to the current product
Original patent protection	Expired
Generic entry	Established
Current regulatory protection	No material exclusivity period identified
Current market structure	Generic and multi-source, subject to actual supplier availability

The key financial point is that oxymetholone cannot rely on patent-protected pricing. Any temporary price increase is more likely to result from supply contraction, wholesaler inventory, manufacturing disruption, or controlled-substance distribution limits.

What patents protect oxymetholone?

No material unexpired U.S. patent protection for oxymetholone as an active pharmaceutical ingredient is publicly evident from the drug’s mature generic status and FDA regulatory history. The relevant patent categories are largely historical:

1. Composition-of-matter patents for oxymetholone.
2. Early tablet and pharmaceutical-composition patents.
3. Potential historical manufacturing or synthesis patents.
4. Product-specific labeling or method-of-use claims.

Those rights do not create a current barrier comparable to the patent estates for newer hematology products.

What is the Orange Book status of oxymetholone?

The FDA Orange Book may identify the reference listed drug and approved abbreviated new drug applications, but oxymetholone does not have a commercially meaningful Orange Book patent estate comparable to a recently approved branded medicine [5]. Any listed patent information must be assessed against the current edition of the Orange Book and the specific NDA or ANDA record.

For commercial purposes, the absence of a relevant active patent listing means that Paragraph IV litigation is unlikely to be the primary entry issue. A prospective generic entrant would generally focus on ANDA approval, bioequivalence, controlled-substance requirements, manufacturing validation, and reliable supply.

Are there Paragraph IV challenges to oxymetholone?

Paragraph IV risk is low because generic oxymetholone products are already established and the reference product has no apparent active patent barrier that would support a major current challenge.

A Paragraph IV certification is relevant when an ANDA applicant asserts that a listed patent is invalid, unenforceable, or not infringed. For a decades-old genericized product, the more important questions are whether:

• The applicant can source compliant active pharmaceutical ingredient.
• The finished product meets dissolution and bioequivalence requirements.
• The manufacturer can comply with DEA controls.
• The applicant can maintain commercial supply at a viable margin.
• The product has an approved labeling basis.

Litigation risk would rise only if a new formulation, delivery system, or narrow method of use obtained a valid later patent. That scenario does not define the current oxymetholone market.

What formulations are protected by oxymetholone patents?

The commercially relevant form is the immediate-release oral tablet, commonly 50 mg. No commercially significant active patent estate is known to protect a current oxymetholone formulation.

Potential formulation opportunities include:

• Lower-dose tablets for titration.
• Modified-release oral products.
• Abuse-deterrent formulations.
• Combination products for marrow-failure syndromes.
• Improved stability or moisture-resistant tablets.
• Pediatric or geriatric dosage forms.

These concepts would face clinical, regulatory, and commercial hurdles. A new formulation could obtain patent protection if it delivered a non-obvious technical benefit, but it would not automatically eliminate substitution by existing immediate-release generics.

How strong is the oxymetholone patent estate?

The patent estate is weak from a current commercial perspective.

Patent-estate factor	Assessment
Active ingredient protection	Expired
Core product patent	Expired or commercially irrelevant
Formulation protection	No material current barrier identified
Method-of-use protection	No material current barrier identified
Manufacturing exclusivity	Not apparent
Regulatory exclusivity	None of practical commercial significance
Freedom-to-operate risk	Generally lower than for newer branded drugs
Value of patent licensing	Limited for legacy oxymetholone

The absence of a strong patent estate shifts competitive advantage to manufacturing economics, regulatory execution, distribution access, and supply reliability.

What FDA regulatory issues affect oxymetholone?

Oxymetholone is subject to standard prescription-drug requirements and additional controls applicable to anabolic steroids. The Anabolic Steroids Control Act places oxymetholone within Schedule III of the Controlled Substances Act [4].

The FDA label identifies clinically important risks, including cholestatic hepatitis, peliosis hepatis, hepatic tumors, adverse lipid changes, edema, virilization, menstrual abnormalities, and suppression of gonadotropin function [1]. These risks restrict broad prescribing and increase monitoring requirements.

Manufacturers and distributors must manage:

• DEA registration and controlled-substance recordkeeping.
• Quotas and inventory controls where applicable.
• Diversion prevention.
• Adverse-event reporting.
• Current good manufacturing practice compliance.
• Labeling consistency across approved generic products.
• Distribution controls for pharmacies, hospitals, and wholesalers.

Does oxymetholone face biosimilar risk?

No. Oxymetholone is a chemically synthesized small molecule, not a biologic. Biosimilar competition is therefore irrelevant. The competitive threat comes from generic tablets, therapeutic substitution, and alternative anemia treatments.

Which companies are challenging the oxymetholone market?

The market is not defined by a high-profile branded-versus-generic patent contest. Competition typically comes from manufacturers of generic oxymetholone tablets and distributors that supply specialty pharmacies, hospitals, and wholesalers.

Company-level market share is difficult to establish from public filings because oxymetholone sales are generally embedded in broader generic portfolios. The reference-brand economics also appear limited compared with major branded hematology products.

The likely competitive variables are:

• Number of active approved manufacturers.
• Availability of qualified API suppliers.
• Manufacturing-site continuity.
• Wholesale acquisition cost and reimbursement.
• Controlled-substance distribution capability.
• Ability to maintain inventory despite low demand.

What is the financial trajectory for oxymetholone?

Oxymetholone’s revenue trajectory is structurally mature to declining in volume, with possible episodic increases in nominal pricing. The product lacks the characteristics that support sustained pharmaceutical revenue growth: there is no active patent moat, no expanding indication base, no biologic exclusivity, and no major direct-to-consumer market.

Revenue drivers

Revenue can rise temporarily when:

• A competing supplier exits.
• A manufacturing site experiences a disruption.
• Hospital or wholesaler inventories fall.
• Reimbursement supports higher generic prices.
• A manufacturer acquires a product with an established distribution channel.

Revenue constraints

Revenue is constrained by:

• Small approved patient populations.
• Therapeutic substitution.
• Safety-related prescribing limits.
• Generic price competition.
• Low manufacturer willingness to maintain a niche product.
• DEA and compliance costs.
• Limited opportunity for indication expansion.

A reasonable commercial classification is low-revenue specialty generic rather than growth pharmaceutical. Product-level forecasts should use volume, supplier count, and realized net price rather than branded prescription growth assumptions.

What generic launch risks exist for oxymetholone?

A new entrant could obtain regulatory approval without confronting a major patent barrier, but approval would not guarantee profitable launch economics.

Launch risk	Commercial effect
Small patient population	Limits achievable volume
API supplier concentration	Raises cost and interruption risk
Controlled-substance requirements	Increases compliance burden
Low generic price ceiling	Compresses gross margin
Established suppliers	Limits pharmacy and wholesaler access
Safety monitoring	Restricts demand expansion
Irregular demand	Creates inventory and forecasting problems
Alternative therapies	Reduces long-term volume

The most credible launch strategy would be a focused specialty-generic model with contract manufacturing, disciplined inventory management, and established hematology distribution. A large standalone manufacturing investment would be difficult to justify without broader portfolio synergies.

What patent litigation and licensing deals affect oxymetholone?

No major current patent litigation or high-value licensing transaction is central to the oxymetholone market. The product’s commercial history predates modern specialty-pharmaceutical partnering structures, and its patent protection has expired.

Licensing value could arise from a reformulated product, a combination therapy, or a new indication. Any such transaction would depend on clinical differentiation and enforceable intellectual-property claims. A license covering only legacy oxymetholone tablets would have limited negotiating value because generic alternatives are available.

How does oxymetholone compare with competing anemia drugs?

Product category	Position relative to oxymetholone
Erythropoiesis-stimulating agents	More established in selected anemia settings, but indication-specific and costly
Eltrombopag	Important in aplastic anemia and may reduce reliance on androgens [2]
Danazol	Mechanistically and clinically closer in some marrow-failure uses
Transfusion support	Immediate supportive treatment, with cumulative burden
Stem-cell transplantation	Potentially curative for eligible patients, but intensive and resource-dependent
Immunosuppressive therapy	Standard option for severe aplastic anemia in appropriate patients
Myelofibrosis therapies	May address disease biology and anemia through different mechanisms

Oxymetholone retains value where clinicians seek an oral, established, relatively inexpensive option and where alternatives are unsuitable. Its role is more defensive and niche than expansionary.

What is the geographic coverage of oxymetholone?

Oxymetholone has historically been marketed in multiple countries, but product availability varies by jurisdiction. Regulatory status, controlled-substance rules, local reimbursement, and manufacturer strategy determine whether it is commercially supplied.

The United States remains the most relevant market for Orange Book, ANDA, DEA, and generic-entry analysis. International markets may have different brands, strengths, prescription controls, and approval histories. Global revenue cannot be inferred from U.S. regulatory status.

Key Takeaways

• Oxymetholone is a mature oral anabolic steroid used mainly in specialized anemia treatment.
• Anadrol-50 is the best-known U.S. reference product, generally associated with a 50-mg tablet.
• Core patent protection and meaningful regulatory exclusivity have expired.
• No active patent estate appears to create a significant U.S. generic-entry barrier.
• Paragraph IV litigation is not the central commercial risk.
• The product has no biosimilar exposure because it is a small molecule.
• Revenue is likely low, mature, and dependent on supplier continuity rather than market expansion.
• Supply disruption can produce temporary price increases in a niche generic market.
• Future value would require a differentiated formulation, new indication, or portfolio-based distribution strategy.
• Manufacturing compliance, DEA controls, API sourcing, and reliable distribution are more important than patent enforcement.

FAQs

Is oxymetholone still FDA approved?

Yes. Oxymetholone remains associated with FDA-approved labeling for specific anemia indications, including acquired aplastic anemia and related deficient-red-cell-production disorders [1].

Is Anadrol-50 still a patented drug?

No current patent protection appears to provide meaningful exclusivity for the legacy oxymetholone tablet. The product is commercially treated as a mature genericized medicine.

Can a company launch generic oxymetholone without a Paragraph IV lawsuit?

Potentially. Because the product lacks an apparent active patent barrier of commercial significance, an ANDA applicant would more likely rely on a certification pathway that does not require challenging an unexpired listed patent, subject to the FDA’s current Orange Book records.

Is oxymetholone used more for bodybuilding than anemia?

Nonmedical performance-enhancing use is widely associated with oxymetholone, but it is outside the FDA-approved pharmaceutical market. Legal pharmaceutical demand is concentrated in specialist anemia treatment.

What is the biggest investment risk in oxymetholone?

The primary risk is weak and irregular demand combined with manufacturing and controlled-substance compliance costs. A supplier can face poor margins even when temporary shortages support higher market prices.

References

1. U.S. Food and Drug Administration. (2004). Anadrol-50 (oxymetholone tablets, USP) prescribing information. FDA/DailyMed labeling record.

2. U.S. Food and Drug Administration. (2018). Promacta (eltrombopag olamine) prescribing information. FDA.

3. Killick, S. B., Bown, N., Cavenagh, J., Dokal, I., Foukaneli, T., Hill, A., Hillmen, P., Ireland, R., Kulasekararaj, A., Mufti, G., Snowden, J. A., Samarasinghe, S., & British Society for Haematology. (2016). Guidelines for the diagnosis and management of adult aplastic anaemia. British Journal of Haematology, 172(2), 187-207.

4. U.S. Drug Enforcement Administration. (2024). Controlled substances act: Schedule III anabolic steroids. U.S. Department of Justice.

5. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, 44th edition. FDA.