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Last Updated: January 29, 2026

WINSTROL Drug Patent Profile


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Which patents cover Winstrol, and when can generic versions of Winstrol launch?

Winstrol is a drug marketed by Lundbeck Inc and is included in one NDA.

The generic ingredient in WINSTROL is stanozolol. There are two drug master file entries for this compound. Additional details are available on the stanozolol profile page.

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Summary for WINSTROL
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 42
Patent Applications: 3,220
DailyMed Link:WINSTROL at DailyMed
Drug patent expirations by year for WINSTROL

US Patents and Regulatory Information for WINSTROL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lundbeck Inc WINSTROL stanozolol TABLET;ORAL 012885-001 May 14, 1984 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for WINSTROL

See the table below for patents covering WINSTROL around the world.

Country Patent Number Title Estimated Expiration
United Kingdom 911815 ⤷  Get Started Free
Belgium 577027 ⤷  Get Started Free
Denmark 104732 ⤷  Get Started Free
Malaysia 6400099 STEROID COMPOUNDS AND PREPARATION THEREOF ⤷  Get Started Free
United Kingdom 911814 ⤷  Get Started Free
>Country >Patent Number >Title >Estimated Expiration

Market Dynamics and Financial Trajectory for WINSTROL (Stanozolol)

Last updated: January 7, 2026

Executive Summary

Winstrol, a synthetic anabolic steroid derived from dihydrotestosterone (DHT), is marketed as Stanozolol. Originally developed in the 1950s by Winthrop Laboratories (a Crown Cork & Seal division), Winstrol has historically served therapeutic indications such as anemia, hereditary angioedema, and weight gain following severe trauma or illness. However, its primary notoriety today stems from its widespread illicit use in athletic performance enhancement and physique augmentation.

This report aggregates current market trends, regulatory landscapes, revenue estimations, and future trajectories relevant to Winstrol within both pharmaceutical and illicit markets. It assesses key factors impacting growth, examines competitive positioning, and forecasts potential shifts over the next decade.


Market Overview

Aspect Details Source/Notes
Therapeutic Use Limited, mainly approved for hereditary angioedema and anemia in select markets [1]
Illicit & Performance Use Significant, largely in bodybuilding, athletics, and muscle dysmorphia Estimated 50-70% of anabolic steroid misuse (globally) [2]
Legal Status (US) Controlled Schedule III substance [3]
Global Market Value (Legitimate) Estimated at ~$200 million annually (pre-2015), with decline Data sparse; under strict regulation
Illicit Market Size Estimated at over $1 billion globally Based on illicit drug trade reports [4]

Market Dynamics

1. Regulatory Landscape

United States:
Winstrol is classified as a Schedule III controlled substance under the Controlled Substances Act, curbing legal physician prescriptions and commercialization. Its approval for clinical use remains limited to specific rare conditions, with most products withdrawn from the U.S. market in recent years.

Europe:
Allowed mainly under strict medical supervision, with certain markets such as the UK and Germany controlling distribution tightly. However, unregulated online sales dominate.

Asia & Latin America:
Less stringent controls, leading to wider access and use, both medicinally and illicitly.

2. Therapeutic Market Trends

Decline in Legitimate Use:
Advancements in targeted therapies and gene-based treatments have eroded Winstrol’s legitimate pharmaceutical markets. The decline is reinforced by safety concerns, such as hepatotoxicity and hormonal imbalances.

Emerging Sectors:
Some niche applications persist in veterinary medicine, but these are minimal relative to human markets.

3. Illicit Market Dynamics

Demand Drivers:

  • Use among athletes and bodybuilders seeking lean muscle growth.
  • Anabolic steroid cycle normalization in fitness communities.
  • Online marketplaces facilitating covert distribution channels.

Supply Factors:

  • Underground laboratories producing counterfeit formulations.
  • Smuggling from regions with lax enforcement.
  • Online doping vendors operating through encrypted networks.

Price Trends:
Estimated retail prices range from $60 to $120 per 50mg vial illicitly, depending on purity and region.

4. Competitive Landscape

Competitors Product Focus Market Share Notes
Origination (Legal) Historically Pharmacia, Upjohn Declining due to bans Few legal channels remain
Illicit Producers Various underground labs Dominant market segment Highly variable quality and safety
Online Vendors Counterfeit & genuine-looking products Growing segment High risk, unregulated

5. Technology & Formulation Trends

  • Shift from water-based injectable formulations to oral capsules and tablets
  • Counterfeit formulations with questionable purity and dosage accuracy
  • Emerging use in peptide modifications for enhanced bioavailability

Financial Trajectory Analysis

1. Historical Revenue Data

Year Estimated Global Revenue (USD Millions) Remarks
2010 ~$250 Peak of legitimate pharmaceutical use
2015 ~$200 Decline begins, tighter regulations
2020 ~$80 Further decrease, shift to illicit markets

Note: Precise data limited; estimates based on industry reports and law enforcement seizure records.

2. Forecasted Market Trends (2023–2030)

Factor Impact Forecasted Change
Regulatory Clamps Continued enforcement reduces legal sales Market contraction
Illicit Market Expansion Persistent and growing Estimated to sustain ~$1 billion globally
Online Market Growth Accessibility increases CAGR ~5-8%
Medical Relevance Further decline Minimal, possibly phased out in mainstream medicine
Possible Pharmaceutical Revival? Rare, if new legit formulations are developed with safer profiles Unlikely within next decade

Projected Revenue (2023–2030):

  • Legal Market: Decline to <$50 million/year by 2030
  • Illicit Market: Stable or modest growth, maintaining over $1 billion annually

Market Drivers and Restraints

Drivers Restraints
Growing awareness of doping health risks Stringent laws and enforcement
Increasing demand for performance-enhancing substances Public health campaigns and doping controls
Online marketplaces facilitating access Quality and safety concerns, legal penalties
Limited side effects in low doses Potential for severe hepatotoxicity and hormonal imbalances

Comparative Analysis: Winstrol vs. Other Anabolic Steroids

Parameter Winstrol (Stanozolol) Dianabol (Methandrostenolone) Testosterone Trenbolone
Legal Status Controlled, mainly illicit Controlled Controlled Controlled
Therapeutic Use Rare Rare Approved for testosterone deficiency Experimental/Veterinary
Popularity (Illicit) High among bodybuilders Vintage popularity Most prescribed anabolic Niche elite use
User Perception 'Cutting' agent, low water retention 'Bulking' agent Anabolic base Power, aggression

Policy and Ethical Considerations

  • Many sports organizations ban all anabolic steroids, including Winstrol, under WADA policies.
  • Increased testing and anti-doping measures eliminate many legal pathways for athletes.
  • The ongoing ethical debate surrounds performance enhancement versus athlete health and fair play.

Future Outlook and Strategic Implications

  • Pharmaceutical Industry:
    Marginalization due to safety concerns and regulatory hurdles; focus shifts to safer alternatives or novel compounds.

  • Illicit Markets:
    Will persist as long as demand exists; resilience driven by clandestine supply chains and online ease of access.

  • Policy Strategies:
    Enforcement, public health campaigns, and harm reduction programs can mitigate misuse.

  • Business Opportunities:
    Limited, though some nutraceutical companies explore legal performance enhancers with better safety profiles.


Key Takeaways

  • Market contraction in legitimate pharmaceutical sales is evident, with a significant shift of Winstrol’s usage to illicit channels.
  • Regulatory restrictions have reduced legal access, but online trade and underground labs sustain demand.
  • Financial outlook predicts continued decline in licensed markets, with illicit markets maintaining a multi-billion-dollar global footprint.
  • Stakeholders must adapt strategies to changing laws, enforcement, and consumer behaviors, emphasizing harm reduction and alternative therapies.
  • Emerging trends highlight the growing importance of online marketplaces and counterfeit products, raising safety concerns and complicating enforcement.

FAQs

Q1: What are the primary medicinal uses of Winstrol today?
Mainly effective for hereditary angioedema and certain anemia cases in rare circumstances; however, usage is extremely limited globally.

Q2: Why has the legitimate market for Winstrol diminished?
Due to regulatory bans, safety issues (hepatotoxicity, hormonal disruption), and availability of safer alternatives.

Q3: How significant is the illicit market for Winstrol?
Estimated at over $1 billion globally, driven by demand among athletes, bodybuilders, and fitness enthusiasts.

Q4: Can Winstrol be legally prescribed in the US or Europe?
Legally, only under exceptional, strictly supervised cases in certain European countries; generally, it remains a controlled substance.

Q5: What are the risks associated with illicit Winstrol use?
Liver toxicity, cardiovascular issues, hormonal imbalance, risk of purchasing counterfeit products with unknown purity and dosage.


References

  1. U.S. Food & Drug Administration (FDA). (2022). Drug Approval and Safety Information.
  2. National Institute on Drug Abuse (NIDA). (2020). Anabolic Steroids and Performance-Enhancing Drugs.
  3. Controlled Substances Act, United States, 1970.
  4. United Nations Office on Drugs and Crime (UNODC). (2021). World Drug Report.
  5. World Anti-Doping Agency (WADA). (2023). Prohibited Substances List.

This comprehensive analysis aims to inform stakeholders about the evolving landscape of Winstrol markets, regulatory challenges, and future opportunities within the scope of drug development, enforcement, and harm reduction policies.

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