FLUOXYMESTERONE - Generic Drug Details

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

Fluoxymesterone is the generic ingredient in four branded drugs marketed by Valeant Pharm Intl, Upsher Smith Labs, Watson Labs, Pharmacia And Upjohn, and Bristol Myers Squibb, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Summary for FLUOXYMESTERONE

US Patents:	0
Tradenames:	4
Applicants:	5
NDAs:	8
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	2
Patent Applications:	7,493
Drug Prices:	Drug price trends for FLUOXYMESTERONE
What excipients (inactive ingredients) are in FLUOXYMESTERONE?	FLUOXYMESTERONE excipients list
DailyMed Link:	FLUOXYMESTERONE at DailyMed

See drug prices for FLUOXYMESTERONE

Recent Clinical Trials for FLUOXYMESTERONE

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

Sponsor	Phase
Federal University of São Paulo	Phase 4
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4
ASCEND Therapeutics	Phase 2

See all FLUOXYMESTERONE clinical trials

Medical Subject Heading (MeSH) Categories for FLUOXYMESTERONE

Anabolic Agents

Anatomical Therapeutic Chemical (ATC) Classes for FLUOXYMESTERONE

G03BA	3-oxoandrosten (4) derivatives
G03B	ANDROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

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
Bristol Myers Squibb	ORA-TESTRYL	fluoxymesterone	TABLET;ORAL	011359-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pharmacia And Upjohn	HALOTESTIN	fluoxymesterone	TABLET;ORAL	010611-006	Approved Prior to Jan 1, 1982		DISCN	No	No
Upsher Smith Labs	FLUOXYMESTERONE	fluoxymesterone	TABLET;ORAL	088342-001	Oct 21, 1983		DISCN	No	No
Watson Labs	FLUOXYMESTERONE	fluoxymesterone	TABLET;ORAL	088260-001	Dec 6, 1983		DISCN	No	No

Fluoxymesterone Market Dynamics, Financial Trajectory, Patents, and Generic Competition

Last updated: September 2, 2026

Fluoxymesterone is a mature, low-volume anabolic androgenic steroid with limited commercial growth potential. The U.S. market is generic, fragmented, and commercially opaque. Historical brand sales are no longer a meaningful indicator because Halotestin has lost practical exclusivity and current demand is concentrated in narrow prescription indications. Public sources do not report reliable product-level revenue for fluoxymesterone, so financial analysis must rely on regulatory status, prescription-market structure, product availability, pricing behavior, and manufacturer participation.

What is fluoxymesterone and how is it marketed?

Fluoxymesterone is an orally active synthetic androgen marketed historically under the brand name Halotestin. It is related structurally to testosterone and is used in approved labeling for male androgen deficiency, delayed puberty in males, and selected cases of advanced inoperable breast cancer in women. The drug is supplied primarily as oral tablets, commonly in 2 mg, 5 mg, and 10 mg strengths, depending on the manufacturer and market.

Market attribute	Fluoxymesterone position
Active ingredient	Fluoxymesterone
Historical brand	Halotestin
Dosage form	Immediate-release oral tablet
U.S. regulatory category	Prescription drug
Controlled-substance category	DEA Schedule III anabolic steroid
Main approved uses	Male hypogonadism, delayed puberty, selected breast cancer use
Market structure	Generic and low-volume
Biosimilar exposure	None
Patent-led exclusivity	No meaningful current protection identified
Public product revenue	Not separately disclosed
Primary commercial risk	Supply continuity and limited manufacturer participation

Fluoxymesterone is distinct from testosterone replacement products that dominate the broader androgen market. Testosterone has injectable, transdermal, buccal, and oral formulations with substantially larger patient populations and stronger commercial support. Fluoxymesterone remains a niche product because of its hepatotoxicity profile, limited modern guideline use, controlled-substance status, and availability of alternative androgen therapies.

What is the FDA regulatory status of fluoxymesterone?

Fluoxymesterone is an FDA-approved prescription active ingredient, but its market is based on legacy approvals and abbreviated new drug applications rather than recent innovation. The FDA-approved product category is not equivalent to a high-growth specialty pharmaceutical market.

The FDA labeling identifies clinically important risks associated with oral 17-alpha-alkylated androgens, including cholestatic hepatitis, jaundice, peliosis hepatis, hepatic neoplasms, lipid changes, edema, virilization, and suppression of gonadal function. These safety concerns constrain use and reduce the likelihood of broadening the addressable market.

Is fluoxymesterone a controlled substance?

Yes. Fluoxymesterone is an anabolic steroid listed by the U.S. Drug Enforcement Administration as a Schedule III controlled substance. The scheduling requirement increases prescribing, dispensing, inventory, recordkeeping, and compliance burdens. It also limits the commercial attractiveness of launching a marginal-volume product.

The controlled-substance designation does not create market exclusivity. It is a regulatory constraint that can raise operating costs and reduce the number of willing manufacturers, wholesalers, and pharmacies.

When did fluoxymesterone lose exclusivity?

Fluoxymesterone lost meaningful brand exclusivity decades ago. Halotestin was introduced in the mid-20th century, and the underlying composition and product patents are long expired. No current patent estate appears capable of preserving premium pricing for the active ingredient itself.

Exclusivity category	Current position
New chemical entity exclusivity	Expired
Original composition patents	Expired
Brand exclusivity	Expired
Orphan-drug exclusivity	None identified
Pediatric exclusivity	None identified
Current formulation exclusivity	No material protection identified
Method-of-use exclusivity	No material current protection identified
Biosimilar exclusivity	Not applicable

The commercial consequence is direct: manufacturers compete primarily on regulatory compliance, supply reliability, wholesaler access, and price rather than on patent differentiation.

What patents protect fluoxymesterone?

No active U.S. patent estate appears to provide meaningful market protection for conventional fluoxymesterone tablets. The relevant protection is historical, not current.

Are formulation patents relevant to fluoxymesterone?

There is no widely recognized modern extended-release, transdermal, implantable, or abuse-deterrent fluoxymesterone formulation with active commercial exclusivity in the United States. Conventional immediate-release tablets are technically straightforward to manufacture and generally vulnerable to generic competition.

A company could seek patent protection for a new delivery system, fixed-dose combination, or differentiated formulation. Such a program would face several commercial obstacles:

• The approved patient population is small.
• Existing alternatives compete across testosterone and androgen categories.
• Safety concerns limit dosing flexibility.
• The product would need clinical and regulatory investment disproportionate to the likely market size.
• A new formulation could trigger separate safety, efficacy, and controlled-substance compliance requirements.

Are there method-of-use patents?

No material, currently relevant method-of-use patent estate is publicly associated with the standard fluoxymesterone tablet market. Historical indications are part of an old label, and generic prescribing can be affected by labeling and indication strategy, but no active method-of-use barrier is widely recognized as limiting generic competition.

How many companies market fluoxymesterone?

The number of active manufacturers varies by country, product strength, time period, and supply status. The United States has historically had a small number of approved generic suppliers rather than a deep field of high-volume competitors. Some companies may retain an approved product while not actively commercializing it.

FDA approval therefore overstates practical competition. A product can appear in regulatory databases without being consistently available through wholesalers or retail pharmacies.

The market is shaped by:

1. Low prescription volume.
2. Limited manufacturing economics.
3. Controlled-substance handling requirements.
4. Small inventory commitments by distributors.
5. Periodic shortages or allocation events.
6. Low willingness to invest in promotional infrastructure.

In a mature generic market, a small supplier base can produce temporary price increases even when the underlying product has no patent protection.

What is the financial trajectory for fluoxymesterone?

Fluoxymesterone has a declining or flat long-term financial profile rather than a growth trajectory. The product has passed through the normal branded life-cycle stages:

Period	Financial and market trajectory
Initial commercialization	Brand-led pricing and physician awareness
Mature brand period	Established use in androgen and oncology indications
Generic entry	Loss of premium pricing and share fragmentation
Current mature market	Low-volume demand, limited promotion, supply-driven pricing
Forward outlook	Stable-to-declining unit demand with episodic price volatility

Public companies generally do not report fluoxymesterone revenue as a separate line item. It is typically embedded within broader generic-drug or specialty-pharmaceutical sales. As a result, there is no dependable public revenue series comparable to products such as testosterone gels, long-acting testosterone injections, or oncology endocrine therapies.

What drives revenue in the fluoxymesterone market?

Revenue is driven more by product availability and reimbursement than by patient growth. Key variables include:

• Number of active suppliers.
• Wholesale acquisition price and generic reimbursement.
• Medicaid and commercial-plan coverage.
• Shortage conditions.
• Prescriber preference for alternative testosterone products.
• Use in specialized oncology settings.
• Controlled-substance distribution costs.
• Pharmacy willingness to stock the product.

Demand is structurally limited. Male hypogonadism treatment has shifted toward testosterone formulations with more favorable administration profiles and monitoring familiarity. Delayed puberty is uncommon and often managed with alternative testosterone products. The historical breast cancer indication has become less commercially important as oncology treatment has evolved.

How does fluoxymesterone compare with competing androgen products?

Fluoxymesterone competes in a much broader androgen market than its own indication set. Its principal competitors include injectable testosterone, transdermal testosterone, oral testosterone undecanoate, testosterone pellets, and other hormonal therapies.

Product category	Commercial scale	Main advantage over fluoxymesterone	Main limitation
Injectable testosterone	High	Low cost and extensive clinical use	Injection burden and monitoring
Transdermal testosterone	High	Convenient administration	Skin-transfer risk and higher cost
Oral testosterone undecanoate	Growing niche	Oral administration without the same legacy positioning	Higher price and monitoring requirements
Testosterone pellets	Moderate niche	Long dosing interval	Procedure required
Fluoxymesterone	Low	Oral dosing and established legacy approval	Hepatic risk, limited modern use, controlled status

Fluoxymesterone’s commercial disadvantage is not only competition from generics. It is also competition from products with stronger current clinical positioning and broader prescriber familiarity.

What generic entry risks exist for fluoxymesterone?

Generic entry risk is effectively structural because the product is already generic. The relevant commercial question is not whether generic entry will occur, but whether suppliers will remain in the market and whether supply disruption will create temporary pricing opportunities.

Potential launch scenarios are:

Stable generic supply

Several suppliers maintain inventory, prices remain compressed, and revenue stays low. This is the base case for a mature generic tablet.

Supplier exit

One or more manufacturers withdraw because of low margins, controlled-substance compliance costs, or manufacturing constraints. Remaining suppliers gain temporary volume and pricing power.

Shortage-driven price expansion

A manufacturing interruption or distributor allocation produces short-term price increases. This can improve gross revenue without increasing underlying demand.

Specialty distributor strategy

A supplier targets hospitals, specialty pharmacies, or selected endocrinology and oncology practices. The strategy can support higher realized pricing but is unlikely to create a large market.

What is the Orange Book status of fluoxymesterone?

The Orange Book is relevant for identifying approved products, therapeutic-equivalence ratings, patents, and exclusivity. Fluoxymesterone’s conventional generic tablets do not appear to depend on an active Orange Book patent listing that could block routine generic competition.

The practical Orange Book position is:

• No meaningful current brand exclusivity.
• No recognized patent barrier for conventional tablets.
• Generic substitution depends on the specific product’s therapeutic-equivalence rating and state pharmacy law.
• Regulatory listing does not guarantee commercial availability.

Any transaction or launch assessment should distinguish between an approved ANDA, an actively marketed product, and a product available through major wholesalers. Those are separate commercial conditions.

Are there Paragraph IV challenges involving fluoxymesterone?

No prominent recent Paragraph IV litigation is associated with the conventional fluoxymesterone tablet market. That outcome is consistent with the product’s age, lack of commercially valuable active patents, and limited expected returns from challenging late-stage secondary patents.

Paragraph IV activity is generally more likely where a branded product has substantial sales and a patent expiry creates a large launch opportunity. Fluoxymesterone does not fit that profile.

What patent litigation affects fluoxymesterone?

No major current patent litigation appears to affect the U.S. conventional fluoxymesterone market. Litigation risk is more likely to arise from:

• Manufacturing-quality disputes.
• Controlled-substance compliance.
• Contract or distribution disagreements.
• Product-liability claims.
• Labeling or adverse-event litigation.

These risks are operational and regulatory rather than patent-driven.

Are there licensing deals for fluoxymesterone?

No major recent licensing transaction centered on fluoxymesterone has been broadly disclosed. The product is an old generic active ingredient, so commercial arrangements are more likely to involve contract manufacturing, supply agreements, distribution rights, or portfolio transfers than high-value intellectual-property licenses.

A licensing transaction would make economic sense only if it included one or more differentiators, such as:

• A reliable source of regulated active pharmaceutical ingredient.
• A specialized controlled-substance manufacturing capability.
• Geographic rights in a market with limited supply.
• A new formulation.
• A hospital or specialty-pharmacy distribution channel.

A license covering only standard fluoxymesterone tablets would have limited strategic value.

What manufacturing and geographic barriers affect the market?

The active ingredient is not technically among the most complex pharmaceutical molecules to manufacture, but the finished product is subject to controlled-substance and quality-system requirements. The main barriers are commercial rather than chemical.

Manufacturing barriers

• Controlled-substance registration and recordkeeping.
• Validated tablet production.
• Potent-compound containment and cleaning controls.
• Consistent supply of qualified active ingredient.
• Small batch economics.
• Regulatory inspection and change-control requirements.
• Limited incentive to maintain redundant production capacity.

Geographic coverage

The United States has the most visible regulatory and controlled-substance framework for the product. Availability in other countries varies substantially. Some jurisdictions may have no approved product, while others may permit limited hospital or specialty use. International sales are constrained by local registration, import controls, controlled-substance rules, and low demand.

A manufacturer with established regulatory approvals in multiple markets could gain supply leverage, but the opportunity remains niche unless it controls a scarce source or solves a recurring availability problem.

Is there biosimilar risk for fluoxymesterone?

No. Fluoxymesterone is a small-molecule drug, not a biologic. Biosimilar competition is legally and technically irrelevant. Generic competition under abbreviated drug-approval pathways is the applicable framework.

What is the investment outlook for fluoxymesterone?

Fluoxymesterone is unlikely to support a conventional branded-growth investment thesis. The more credible investment cases are operational:

• Acquiring a low-cost generic portfolio.
• Securing a reliable controlled-substance manufacturing platform.
• Supplying shortage-prone markets.
• Consolidating a fragmented niche product line.
• Launching a differentiated formulation with a defensible clinical or delivery advantage.

The risk-adjusted outlook for ordinary tablets is weak because pricing power is limited, patient demand is small, and the product has no apparent patent moat. Revenue can rise temporarily through shortages or supplier exits, but those gains are unstable and may attract competing entrants once margins improve.

Key Takeaways

• Fluoxymesterone is a mature generic oral androgen with no meaningful current patent exclusivity.
• Halotestin’s branded commercial position has ended; the market is driven by generic supply and distribution.
• Public companies do not generally disclose fluoxymesterone revenue separately.
• Long-term unit demand is likely flat to declining because prescribers have broader testosterone alternatives.
• Hepatic safety concerns, controlled-substance requirements, and limited indications restrict market expansion.
• No material current Paragraph IV, patent-litigation, biosimilar, or licensing threat is evident.
• The main commercial opportunity is supply reliability, not patent-based pricing.
• The main downside risk is manufacturer withdrawal, shortage exposure, and low-margin economics.
• A new formulation could create exclusivity, but the small addressable market makes development economics difficult.

FAQs

Is fluoxymesterone still commercially available in the United States?

Availability depends on manufacturer inventory, wholesaler supply, and pharmacy ordering. Regulatory approval does not guarantee continuous commercial distribution.

Does fluoxymesterone have a longer patent life than testosterone?

No. Fluoxymesterone is an older active ingredient, and its original intellectual-property protection expired long ago. Current competition is primarily generic.

Can a company obtain orphan-drug exclusivity for fluoxymesterone?

Only a newly established qualifying indication could potentially support orphan designation. The existing conventional product does not have orphan-drug exclusivity.

Why can a generic fluoxymesterone product become expensive?

A small supplier base, controlled-substance compliance costs, low production volume, and temporary shortages can produce price increases despite the absence of patent protection.

Is fluoxymesterone a realistic target for pharmaceutical licensing?

Standard tablets are unlikely to justify a major licensing transaction. A deal would be more credible if it included a differentiated formulation, scarce manufacturing capacity, or rights in a supply-constrained market.

References

1. U.S. Food and Drug Administration. (n.d.). Fluoxymesterone prescribing information. FDA.

2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. FDA.

3. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs database. FDA.

4. U.S. Drug Enforcement Administration. (n.d.). Controlled substances: Anabolic steroids. U.S. Department of Justice.

5. National Library of Medicine. (n.d.). DailyMed: Fluoxymesterone tablet drug labeling. U.S. National Library of Medicine.

6. U.S. Food and Drug Administration. (1984). Drug Price Competition and Patent Term Restoration Act of 1984. FDA.