OXANDROLONE Drug Patent Profile

When do Oxandrolone patents expire, and when can generic versions of Oxandrolone launch?

Oxandrolone is a drug marketed by Par Pharm, Roxane, Sandoz, and Upsher Smith Labs. and is included in five NDAs.

The generic ingredient in OXANDROLONE is oxandrolone. There is one drug master file entry for this compound. Additional details are available on the oxandrolone profile page.

Summary for OXANDROLONE

US Patents:	0
Applicants:	4
NDAs:	5
Raw Ingredient (Bulk) Api Vendors:	30
Clinical Trials:	24
Patent Applications:	3,103
Drug Prices:	Drug price information for OXANDROLONE
DailyMed Link:	OXANDROLONE at DailyMed

See drug prices for OXANDROLONE

Recent Clinical Trials for OXANDROLONE

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

Sponsor	Phase
Science Valley Research Institute	PHASE2
Stin Pharma	PHASE2
University Hospital, Clermont-Ferrand	Phase 2

See all OXANDROLONE clinical trials

Medical Subject Heading (MeSH) Categories for OXANDROLONE

Anabolic Agents

Androgens

Anatomical Therapeutic Chemical (ATC) Classes for OXANDROLONE

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

Paragraph IV (Patent) Challenges for OXANDROLONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OXANDRIN	Tablets	oxandrolone	2.5 mg and 10 mg	013718	1	2006-06-19

US Patents and Regulatory Information for OXANDROLONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Par Pharm	OXANDROLONE	oxandrolone	TABLET;ORAL	077827-001	Jun 22, 2007		DISCN	No	No
Upsher Smith Labs	OXANDROLONE	oxandrolone	TABLET;ORAL	076761-001	Dec 1, 2006		DISCN	No	No
Roxane	OXANDROLONE	oxandrolone	TABLET;ORAL	077249-002	Jul 10, 2007		DISCN	No	No
Upsher Smith Labs	OXANDROLONE	oxandrolone	TABLET;ORAL	078033-001	Mar 22, 2007		DISCN	No	No
Par Pharm	OXANDROLONE	oxandrolone	TABLET;ORAL	077827-002	Jun 22, 2007		DISCN	No	No

Oxandrolone Market Dynamics, Financial Trajectory, Patents, Generic Competition, and FDA Status

Last updated: August 31, 2026

Oxandrolone is a mature, genericized anabolic steroid with limited but durable demand in weight recovery, severe burns, trauma, chronic illness, and selected pediatric indications. Its commercial profile is defined by expired intellectual property, a narrow prescriber base, controlled-substance requirements, intermittent supply constraints, and limited public revenue disclosure. The original brand, Oxandrin, no longer provides a conventional branded-growth platform. Generic oxandrolone remains commercially relevant because few manufacturers serve a small market with specialized clinical demand.

What is the current FDA status of oxandrolone?

Oxandrolone is an FDA-approved oral anabolic steroid marketed in the United States as tablets, historically under the Oxandrin brand and currently through generic products.

The FDA-approved labeling identifies the following uses:

• Promoting weight gain after surgery, chronic infection, or severe trauma.
• Offsetting protein catabolism associated with prolonged corticosteroid treatment.
• Supporting weight and growth in selected pediatric patients.
• Use in patients with severe burns, subject to clinical judgment and institutional practice.

Oxandrolone is a Schedule III controlled substance under the federal Controlled Substances Act. The classification affects prescribing, inventory management, wholesaling, pharmacy controls, and manufacturer compliance obligations.[1][2]

FDA regulatory milestones

Milestone	Status
Active ingredient	Oxandrolone
Dosage form	Immediate-release oral tablet
Original brand	Oxandrin
FDA pathway	Original NDA followed by abbreviated generic approvals
Controlled-substance status	Schedule III
Typical strengths	2.5 mg and 10 mg tablets
Primary commercial market	United States
Biosimilar pathway	Not applicable
Reference-product exclusivity	Expired
Current market structure	Generic and specialty supply

The product is not a biologic and has no biosimilar exposure. Competitive entry occurs through abbreviated new drug applications, not through the biosimilar pathway.

When did oxandrolone lose exclusivity?

Oxandrolone lost meaningful market exclusivity decades ago. Its underlying steroid chemistry and original product rights are legacy assets rather than enforceable barriers to current generic competition.

The original composition-of-matter and product patents associated with oxandrolone were filed in the early development era of anabolic steroids. Those rights expired long before the current generic market formed. Any remaining commercial protection would have depended on later formulation, manufacturing, or regulatory exclusivity rights rather than the active ingredient itself.

What patents protect oxandrolone today?

The current U.S. commercial market does not depend on an active composition-of-matter patent for oxandrolone. The FDA Orange Book does not identify a current patent barrier that prevents ANDA-based competition for the legacy Oxandrin product.[3]

Patent category	Current commercial impact
Composition of matter	Expired
Original oral-tablet claims	Expired or no longer commercially blocking
New chemical entity exclusivity	Expired
Pediatric exclusivity	Expired
Formulation patents	No material current barrier identified in the Orange Book
Method-of-use patents	No current Orange Book-listed barrier that blocks standard generic entry
Manufacturing patents	Could protect a process, but would not prevent all non-infringing generic manufacture
Regulatory exclusivity	Expired

A manufacturer could still pursue a patent covering a specific formulation, process, dosage regimen, or therapeutic use. Such a patent would have to survive validity and infringement challenges and would not recreate broad product exclusivity over oxandrolone.

What is the Orange Book status of Oxandrin and generic oxandrolone?

The FDA Orange Book treats oxandrolone as a mature prescription product with abbreviated-approval competition. The relevant commercial question is not whether oxandrolone has an active brand patent. It is whether enough manufacturers maintain approved, commercially available supply.

The Orange Book framework creates several distinctions:

1. An approved ANDA may exist even when a product is not actively marketed.
2. A discontinued brand or generic may remain visible in FDA records.
3. A patent listing does not guarantee meaningful commercial protection.
4. Product availability can contract even after patent expiry if manufacturers exit or face supply constraints.

Oxandrolone’s practical exclusivity is therefore operational rather than legal. Manufacturing economics, controlled-substance compliance, active pharmaceutical ingredient sourcing, and wholesaler demand can limit supply despite open generic entry.

How many patents cover oxandrolone?

No meaningful active U.S. patent estate currently covers oxandrolone as a broad commercial product. The historical patent estate was directed primarily to the steroid compound and early pharmaceutical use. Those rights are expired.

The more relevant IP questions concern:

• Whether a supplier owns a process patent for oxandrolone synthesis.
• Whether a finished-dose manufacturer has a patent on a particular excipient system.
• Whether a sponsor has claimed a new patient population or dosing schedule.
• Whether a patent is listed in the Orange Book for a specific NDA or ANDA.

None of these categories appears to restore broad exclusivity comparable to a protected new chemical entity.

Are there Paragraph IV challenges for oxandrolone?

Paragraph IV litigation is not a central current market risk for oxandrolone. The principal reason is that the broad patent rights associated with the molecule have expired, leaving limited scope for a brand owner to assert blocking patents against ordinary generic tablet entry.

A Paragraph IV certification is relevant when an ANDA applicant asserts that an Orange Book-listed patent is invalid, unenforceable, or not infringed. For oxandrolone, the greater commercial risks are:

• Generic discontinuation.
• Controlled-substance quota or compliance constraints.
• Active pharmaceutical ingredient supply interruptions.
• Product recalls.
• Low-volume manufacturing economics.
• Wholesaler and hospital contract concentration.

Which companies are challenging Oxandrin patents?

No current, widely reported Paragraph IV campaign defines the oxandrolone market. Generic manufacturers compete primarily through approved abbreviated applications and supply execution rather than through high-value patent litigation.

What formulations are protected by oxandrolone patents?

The commercially established formulation is an immediate-release oral tablet. No current formulation patent appears to create a broad market barrier for the standard 2.5 mg and 10 mg products.

Potential formulation differentiation could involve:

• Tablet hardness and dissolution.
• Taste or swallowability.
• Modified release.
• Pediatric administration.
• Excipient compatibility.
• Packaging and stability.
• Lower-dose products for specialized use.

These modifications could support narrow patent claims, but they would not necessarily prevent competitors from marketing conventional immediate-release tablets.

What patent litigation affects oxandrolone?

Oxandrolone has not generated the type of sustained patent litigation associated with high-revenue medicines such as biologics, specialty oncology products, or reformulated chronic-care therapies. The absence of active broad patents substantially reduces litigation exposure.

The more significant legal and compliance issues are non-patent matters:

• Controlled-substance recordkeeping.
• Promotion and labeling compliance.
• Product quality and manufacturing controls.
• Pricing and reimbursement disputes.
• Supply and distribution agreements.
• Potential off-label promotion concerns involving anabolic steroids.

The litigation profile is therefore low in patent intensity but not risk-free from a regulatory or commercial perspective.

How did Oxandrin’s commercial trajectory develop?

Oxandrin occupied a niche position as a branded anabolic steroid used in medically supervised weight-recovery settings. It did not achieve the scale of mainstream endocrine, oncology, cardiovascular, or immunology products.

Its commercial trajectory followed four stages:

1. Legacy branded development

Oxandrolone entered the market as a prescription anabolic steroid with a differentiated profile relative to older androgenic steroids. Its oral administration and clinical use in catabolic conditions supported continued medical demand.

2. Specialty ownership and price pressure

The product moved through specialty pharmaceutical ownership, including Savient Pharmaceuticals and BTG. BTG acquired rights associated with Oxandrin as part of its specialty pharmaceutical portfolio.[4]

The commercial value of the asset was based on established FDA approval, physician familiarity, limited competition at certain points, and specialized demand. It was not based on a durable patent moat.

3. Generic substitution

Generic approvals reduced the strategic value of the brand. Once multiple generic products became available, payers and pharmacies gained alternatives. The market became more sensitive to supply availability and reimbursement spreads.

4. Mature, low-growth market

The current market is best characterized as mature and fragmented. Demand is stable in defined clinical niches but is unlikely to support major volume growth without a new indication, new formulation, or major access expansion.

What is the financial trajectory of oxandrolone?

Public companies have not generally disclosed standalone oxandrolone revenue in a way that supports a reliable product-level time series. BTG and other owners reported broader portfolio or segment results, not a consistent Oxandrin revenue line.[4][5]

The financial trajectory can therefore be assessed through market structure rather than precise public sales figures.

Financial driver	Historical effect	Current effect
Brand pricing	Supported revenue when competition was limited	Weakens as generic substitution increases
Patent status	No current broad protection	Does not support premium pricing
Clinical niche	Preserves baseline demand	Limits total addressable market
Generic competition	Reduces branded share	Compresses price but can improve access
Manufacturer count	Increases supply resilience when broad	Low count raises shortage risk
Controlled-substance rules	Raises compliance cost	Limits casual market entry
Hospital and burn-center demand	Creates recurring institutional use	Concentrates purchasing power
Pediatric demand	Supports specialized use	Requires careful clinical and regulatory management

Revenue exposure for manufacturers

For a large pharmaceutical company, oxandrolone is unlikely to be material as a standalone revenue driver. For a small generic or specialty manufacturer, the product can still be economically important because:

• Manufacturing scale is limited.
• Competition may be less intense than in high-volume generic categories.
• Institutional customers may value reliable supply.
• Stock-outs can shift disproportionate market share.
• A controlled-substance product can impose higher operating costs.

The asset’s value is therefore asymmetric. It is not usually large enough to move the financial results of a diversified company, but it can matter to a focused supplier with a small portfolio.

How does generic competition affect oxandrolone pricing?

Generic competition places downward pressure on average selling prices, but oxandrolone does not behave like a high-volume commodity generic. The market is constrained by low demand and limited manufacturing participation.

Price behavior can be volatile when:

• One manufacturer exits.
• A major wholesaler loses inventory.
• A production batch fails quality testing.
• API availability tightens.
• A hospital system changes its preferred supplier.
• Controlled-substance production or distribution limits reduce inventory.

This can create a split market: low nominal generic prices during stable supply and sharp price increases during temporary scarcity.

What generic entry risks exist for oxandrolone?

Generic entry risk is high from an intellectual-property perspective but moderate from an operating perspective.

Intellectual-property risk

A new entrant faces little risk from the expired core molecule patents. The principal patent risks would arise from a narrow formulation, process, or use patent associated with a specific product.

Regulatory risk

A generic applicant must demonstrate pharmaceutical equivalence and bioequivalence and comply with FDA manufacturing requirements. Schedule III handling adds controlled-substance obligations.

Commercial risk

The commercial risks are more substantial:

• Small market size.
• Limited reimbursement upside.
• Established supplier relationships.
• Difficulty obtaining predictable API supply.
• Potentially low inventory turns.
• Product liability exposure associated with androgenic and anabolic effects.
• Demand concentration in burn centers, trauma centers, rehabilitation settings, and specialist practices.

A new entrant can obtain approval without achieving sustainable sales. In this market, regulatory entry and commercial viability are separate outcomes.

What manufacturing and IP barriers affect oxandrolone?

The main barriers are manufacturing and compliance barriers rather than patent barriers.

Active pharmaceutical ingredient supply

Oxandrolone API production requires steroid chemistry capabilities, validated controls, impurity management, and reliable documentation. A supplier without established steroid manufacturing infrastructure may face higher development and qualification costs.

Controlled-substance compliance

Manufacturers and distributors must manage:

• DEA registration.
• Quota and ordering procedures.
• Secure storage.
• Inventory reconciliation.
• Theft and diversion controls.
• Record retention.
• Customer due diligence.

These requirements reduce the number of companies willing to enter the market.

Product quality

Oxandrolone tablets require control of potency, content uniformity, dissolution, stability, and impurities. A small market does not eliminate the cost of validation, release testing, and pharmacovigilance.

How does oxandrolone compare with competing anabolic agents?

Oxandrolone competes with other anabolic-androgenic steroids and with non-steroidal approaches to weight recovery. Its competitive position depends on the indication.

Product or category	Competitive relationship
Oxandrolone	Oral anabolic steroid with niche FDA-approved uses
Nandrolone products	Injectable anabolic option used in selected medical settings
Testosterone products	Broader androgen-replacement market, not a direct substitute in every indication
Megestrol acetate	Appetite and weight-related alternative, with a different mechanism and risk profile
Dronabinol	Appetite stimulant in selected settings
Nutritional therapy	First-line or complementary intervention in many patients
Recombinant or specialty catabolic therapies	Potentially higher-cost alternatives for narrow populations

Oxandrolone’s advantages include oral dosing, a long clinical history, and use in specific catabolic conditions. Its disadvantages include anabolic-steroid safety concerns, hepatic monitoring requirements, lipid effects, virilization risk, and limited general-population use.

What is the geographic coverage of oxandrolone?

The United States is the most commercially visible market because of FDA-approved labeling, Orange Book records, and established generic distribution. International availability varies widely.

Geographic demand is affected by:

• National approval status.
• Controlled-drug scheduling.
• Availability of steroid API.
• Reimbursement rules.
• Burn and trauma-center infrastructure.
• National restrictions on anabolic steroids.
• Local generic registration requirements.

A product approved in the United States may not have equivalent commercial status in Europe, Canada, Asia, or Latin America. International sales should not be inferred from U.S. approval or U.S. generic availability.

Is oxandrolone a biosimilar risk?

No. Oxandrolone is a small-molecule drug, not a biologic. Biosimilar competition is legally irrelevant.

The relevant competitors are:

• ANDA-approved generic tablets.
• Authorized generic products, if marketed.
• Compounded products, where lawful and clinically appropriate.
• Other anabolic agents.
• Non-drug nutritional and supportive-care interventions.

What licensing deals affect oxandrolone?

The most commercially relevant historical transaction was the transfer of Oxandrin-related rights to BTG from Savient Pharmaceuticals. BTG later became part of Boston Scientific through its 2019 acquisition.[4][6]

The transaction history demonstrates that oxandrolone had portfolio value as a specialty product, but it does not establish current exclusivity. No widely disclosed recent licensing transaction has repositioned oxandrolone as a growth asset or added a new proprietary platform.

What is the outlook for oxandrolone?

The base-case outlook is stable niche demand with limited revenue growth.

Upside factors

• Persistent use in severe burns and trauma.
• Continued pediatric specialist demand.
• Generic supply disruptions that improve pricing.
• New clinical evidence supporting a defined catabolic indication.
• A differentiated lower-dose or patient-friendly formulation.

Downside factors

• Further generic price compression.
• Brand discontinuation and reduced promotional support.
• Safety concerns involving anabolic steroids.
• Manufacturer exits.
• Tighter controlled-substance oversight.
• Substitution by nutritional therapy, appetite stimulants, or other anabolic agents.
• Low reimbursement margins.

A new indication could expand demand, but it would require clinical evidence, FDA interaction, investment in trials, and a defensible commercial strategy. Existing approval alone is unlikely to produce material market expansion.

Key Takeaways

• Oxandrolone is a mature oral anabolic steroid with narrow but persistent medical demand.
• Its original composition-of-matter and product patents are expired.
• The current FDA market is genericized and has no biosimilar component.
• Oxandrin no longer has the commercial profile of a protected branded medicine.
• Public companies do not generally disclose reliable standalone oxandrolone revenue.
• Market value depends more on supply reliability, controlled-substance compliance, and niche institutional demand than on patent protection.
• Paragraph IV litigation and broad patent challenges are not the primary competitive risks.
• Generic entry is legally straightforward but commercially difficult because of small volume and manufacturing requirements.
• Oxandrolone is unlikely to become a major growth product without a new indication, formulation, or substantial change in clinical practice.

Frequently Asked Questions

Does oxandrolone have an active U.S. composition patent?

No broad active composition patent currently protects oxandrolone as a molecule. The relevant historical rights expired decades ago.

Is Oxandrin still a branded blockbuster drug?

No. Oxandrin is a legacy specialty product. Its market is small relative to major branded pharmaceutical products and is primarily exposed to generic competition.

Can a company launch generic oxandrolone without negotiating with a brand owner?

A company can generally pursue an ANDA-based launch after addressing any applicable FDA-listed patents and regulatory requirements. The expired core patents do not require a license.

Why can oxandrolone prices rise after patent expiry?

Low demand, limited manufacturers, controlled-substance compliance, API constraints, and inventory disruptions can create supply-driven price increases even in a patent-free market.

Is oxandrolone attractive for pharmaceutical licensing?

It may be attractive to a focused specialty or generic company with steroid manufacturing capacity and institutional distribution. It is less attractive as a standalone growth asset for a diversified pharmaceutical company because the market is narrow and lacks meaningful exclusivity.

References

1. U.S. Food and Drug Administration. (2023). Oxandrin (oxandrolone) tablets prescribing information. https://www.accessdata.fda.gov
2. U.S. Drug Enforcement Administration. (2024). Controlled substances act. https://www.dea.gov
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/
4. BTG plc. (2012). Annual report and accounts. https://www.btgplc.com
5. Boston Scientific Corporation. (2019). Annual report on Form 10-K. https://investors.bostonscientific.com
6. Boston Scientific Corporation. (2019). Boston Scientific completes acquisition of BTG plc. https://news.bostonscientific.com