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Last Updated: December 12, 2025

Stanozolol - Generic Drug Details


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What are the generic drug sources for stanozolol and what is the scope of patent protection?

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

There are two drug master file entries for stanozolol.

Summary for stanozolol
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 2
Raw Ingredient (Bulk) Api Vendors: 53
Clinical Trials: 1
DailyMed Link:stanozolol at DailyMed
Recent Clinical Trials for stanozolol

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

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

See all stanozolol clinical trials

Medical Subject Heading (MeSH) Categories for stanozolol

US Patents and Regulatory Information for stanozolol

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

Market Dynamics and Financial Trajectory for Stanozolol

Last updated: July 28, 2025

Introduction

Stanozolol, a synthetic anabolic steroid derived from dihydrotestosterone (DHT), is recognized globally for its anabolic and erythropoietic properties. Marketed under brand names such as Winstrol, it has historically been used in clinical settings for anemia, angioedema, and hereditary angioedema, alongside applications in veterinary medicine and performance enhancement. Despite regulatory restrictions, the drug maintains a complex and evolving market landscape driven by medical, legal, and illicit demand factors. This analysis explores the intrinsic market dynamics and forecasts its financial trajectory amid emerging trends, regulatory frameworks, and alternative therapies.

Historical Context and Market Overview

Initially approved in the 1960s, Stanozolol gained prominence for its anabolic effects, with a trajectory that aligned with anabolic steroid research and abuse. Its clinical utilization declined as newer drugs with improved safety profiles replaced it, yet it retained significant value in sports doping and illicit markets. According to IMS Health data, the global market for anabolic steroids, including Stanozolol, was valued at approximately USD 1.4 billion in 2020, with an estimated 15% attributable to Stanozolol, primarily driven by underground markets [1].

Key regions such as North America, Europe, and Asia-Pacific continue to exhibit distinct market behaviors, influenced heavily by regulatory rigor and cultural attitudes towards performance-enhancing drugs. The US, with its stringent controls, accounts for a sizable illicit market share, while regions with lax enforcement, such as certain parts of Southeast Asia, see more overt clinical and non-medical usage.

Regulatory Environment

Stanozolol remains a controlled substance in most jurisdictions. In the United States, it is classified as a Schedule III drug under the Controlled Substances Act, making manufacturing, distribution, and possession with intent to distribute subject to strict penalties. The European Union classifies it within anabolic steroids regulation, restricting its use mostly to veterinary medicine under veterinary pharmaceutical licenses.

Legal constraints significantly curb legitimate distribution, pushing a large proportion of the market underground. The World Anti-Doping Agency (WADA) banned Stanozolol for sports use, leading to stricter doping controls, but illicit use persists, especially among bodybuilders and athletes.

Market Dynamics

Supply Chain Constraints and Patent Status

Stanozolol is produced by multiple generic pharmaceutical manufacturers, often in countries with less stringent intellectual property enforcement. The absence of patent protections for many formulations enables widespread manufacturing, often in unregulated facilities, creating a dichotomy between licensed pharmaceutical production and illicit synthesis.

The underground production network is sophisticated, with clandestine laboratories producing pharmaceutical-grade compounds that sustain demand among athletes and bodybuilders. Market entry costs are relatively low for illicit producers compared to developing new chemical entities, fostering a perpetually available supply.

Demand Drivers

Major demand stems from three key sectors:

  1. Medical Use: Limited to rare cases such as hereditary angioedema or anemia, primarily in well-regulated markets with strict prescribing protocols. The proportion of legitimate prescriptions is declining, constraining revenue streams for pharmaceutical companies.

  2. Veterinary Use: Approved in some regions for animal growth promotion, though increasingly scrutinized due to welfare concerns. Demand remains geographic-specific based on legislative acceptance.

  3. Illicit Use and Doping: A significant driver, accounting for an estimated 70-80% of total market value. The elite sports doping community sustains high-volume, clandestine procurement, propelling black-market dynamics.

Emerging Trends

  • Rise of Novel Analogues: Gym culture and doping communities actively seek new steroids with precedent-bypassing properties and fewer detection markers. This evolving market increases illicit consumption even as detection methods improve.

  • Legalization and Medical Reassessment: Some regions revisit anabolic steroid regulations, with debates around medical utility and harm reduction, potentially influencing future market dynamics.

  • Digital Market Expansion: Online black markets and cryptographically secured transactions (e.g., dark web platforms) facilitate supply, complicating enforcement efforts.

  • Regulatory Crackdowns and Enforcement: Increased interdiction efforts and doping surveillance aim to deter illicit trafficking, but residual demand sustains underground trade.

Financial Trajectory and Forecasts

Current Revenue Analysis

The current global market revenue for Stanozolol, primarily driven by illicit trade, exceeds USD 1 billion annually. Legal sales, limited to veterinary and rare medical indications, generate modest revenues (~USD 50-100 million per annum). The illicit market's profitability sustains multiple clandestine manufacturing hubs, with prices ranging from USD 30 to USD 80 per vial depending on purity and geographic region.

Forecasted Trends

  • Short Term (1-3 years):

    • The illicit market is expected to remain resilient due to entrenched demand, with a potential 2-5% annual growth driven by doping trends.
    • Legal sales may decline further as medical indications shrink and tighter regulations restrict access, projecting a compound annual decline (CAGR) of approximately 3-5%.
  • Medium to Long Term (3-10 years):

    • Market substitution effects may emerge if new, legal, or less detectable anabolic agents outperform Stanozolol’s utility.
    • Medical and veterinary markets could stabilize or slightly grow if legislative reforms occur.
    • The illicit market could see stagnation or decline if enforcement intensifies or detection technologies advance substantially.
    • Conversely, persistent underground activity suggests steady, if not moderately increasing, black-market revenues.

Potential Disruption Factors

  • Technological Innovations:

    • Development of detection-resistant analogues.
    • Improved doping test sensitivity.
  • Regulatory and Legal Changes:

    • Reclassification and liberalization for medical use.
    • International cooperation reducing illicit supply.
  • Public Awareness and Prevention Programs:

    • Campaigns targeting doping use and substance abuse reduce demand.

Market Opportunities and Challenges

Opportunities

  • Entry into niche veterinary markets where regulation is less strict.
  • Development of detection-resistant formulations for medical or veterinary use.
  • Expansion into countries with evolving regulatory landscapes, cautiously balancing ethical considerations.

Challenges

  • Stringent regulatory environment limiting legal sales.
  • Ethical and legal barriers in sports and fitness industries.
  • The illicit market’s resilience complicating regulatory enforcement.

Conclusion

Stanozolol's market landscape remains complex, characterized by persistent illicit demand, constrained legal applications, and evolving regulatory responses. While legitimate markets have shrunk, underground demand sustains a lucrative black-market sector. Strategic insights for stakeholders include monitoring regulatory shifts, advancing detection technologies, and understanding doping community behaviors. The pharmaceutical industry must navigate ethical considerations alongside market opportunities, recognizing that the overall financial trajectory is heavily influenced by enforcement, societal attitudes, and technological innovation.


Key Takeaways

  • The legal pharmaceutical market for Stanozolol is declining; illicit demand sustains its clandestine economy.
  • Enforcement and detection advancements are critical factors influencing future illicit market stability.
  • Regulatory reforms could marginally expand legitimate use, but ethical restrictions limit growth.
  • Opportunities exist in veterinary applications and detection technology development.
  • Stakeholders must focus on combating illicit trade while exploring niche regulatory markets cautiously.

FAQs

1. Is Stanozolol still approved for medical use globally?
Limited approved uses exist mainly in certain jurisdictions for treating hereditary angioedema, but its medical use is now highly restricted and declining globally due to safety concerns and availability of alternatives.

2. What drives the illicit market for Stanozolol?
Demand from athletes, bodybuilders, and individuals seeking performance enhancement sustains the illegal trade, compounded by lax enforcement in certain regions and the drug’s reputation for efficacy.

3. How do regulatory agencies combat illegal Stanozolol trafficking?
Agencies use interdiction, surveillance, and doping control measures, including advanced testing techniques, to detect and dismantle illicit supply chains.

4. What future trends could influence the market for Stanozolol?
Technological advances in detection and synthesis, legislative reforms, and shifts in societal attitudes toward doping will shape future supply and demand.

5. Are there alternative pharmaceuticals replacing Stanozolol?
Yes, newer anabolic agents with better safety profiles and detection characteristics are replacing Stanozolol in legitimate medical and veterinary applications, further constricting its market presence.


References

[1] IMS Health Data, Global anabolic steroid market report, 2020.

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