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Last Updated: March 16, 2025

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: 53
Patent Applications: 2,939
DailyMed Link:WINSTROL at DailyMed
Drug patent expirations by year for WINSTROL

US Patents and Regulatory Information for WINSTROL

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Lundbeck Inc WINSTROL stanozolol TABLET;ORAL 012885-001 May 14, 1984 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

International Patents for WINSTROL

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

CountryPatent NumberTitleEstimated Expiration
Denmark 104732 ⤷  Try for Free
Netherlands 100550 ⤷  Try for Free
Switzerland 377336 Procédé de préparation de stéroïdes ⤷  Try for Free
United Kingdom 911814 ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 4 of 4 entries

Market Dynamics and Financial Trajectory of Winstrol (Stanozolol)

Introduction

Winstrol, known chemically as stanozolol, is a synthetic androgen and anabolic steroid (AAS) that has been in the market since 1962. Developed by Winthrop Laboratories (later part of Sterling Drug), it was initially marketed under the brand names Winstrol in the US and Stromba in Europe. Here, we will delve into the market dynamics and financial trajectory of this drug.

Historical Context and Initial Market Entry

Stanozolol was first introduced to the market in 1962 by Winthrop Laboratories in the US and by Bayer in Europe. It was approved by the U.S. Food and Drug Administration (FDA) for various medical indications, including hereditary angioedema, osteoporosis, and certain cases of anemia[1][4].

Therapeutic Uses and Market Position

Initially, Winstrol was prescribed for a range of medical conditions, including hereditary angioedema, aplastic anemia, and as an adjunct therapy for senile and postmenopausal osteoporosis. However, over the years, its therapeutic uses have been narrowed down due to the lack of sufficient evidence for its efficacy in many of these conditions. By the 1980s, the FDA had begun to restrict its use, eventually limiting it primarily to hereditary angioedema[1].

Regulatory Changes and Market Impact

The regulatory landscape for Winstrol has been tumultuous. In the 1970s and 1980s, the FDA required Sterling to submit additional data to support the drug's efficacy for various indications. Despite this, the FDA ultimately withdrew the marketing authority for several of these indications in 1984. This significantly reduced the drug's market presence and revenue[1].

Acquisition and Ownership Changes

The ownership of Winstrol has changed hands several times. In 1988, Sterling was acquired by Eastman Kodak, and in 1994, Kodak sold the drug business to Sanofi. Sanofi had the drug manufactured by Searle until 2002. Later, Sanofi sold the Winstrol business to Ovation Pharmaceuticals in 2003. In 2009, Lundbeck purchased Ovation Pharmaceuticals, and in 2010, Lundbeck withdrew Winstrol from the US market[1].

Financial Trajectory

The financial performance of Winstrol has been influenced by its declining market presence and regulatory restrictions. Here are some key financial milestones:

  • Acquisition Costs: When Eastman Kodak acquired Sterling in 1988, the deal was valued at $5.1 billion. Later, when Kodak sold the drug business to Sanofi in 1994, the deal was worth $1.675 billion. These figures indicate the significant value the drug held at different points in its history[1].
  • Market Withdrawal: The withdrawal of Winstrol from the US market in 2010 marked a significant financial downturn. Although it could still be obtained through compounding pharmacies, this limited its commercial availability and revenue[1].

Market Dynamics and Competition

Winstrol's market dynamics have been heavily influenced by its therapeutic limitations, regulatory challenges, and competition from other anabolic steroids and alternative treatments.

  • Therapeutic Limitations: The narrowing of its approved indications and the lack of strong evidence for its efficacy in many conditions have reduced its market share and revenue.
  • Regulatory Challenges: Being classified as a Schedule III controlled substance under the Anabolic Steroid Control Act of 1990 and subsequent updates has further restricted its use and availability[4].
  • Competition: The market for anabolic steroids is competitive, with other drugs offering similar or better therapeutic profiles. Additionally, the advent of human growth hormone and other treatments has reduced the need for Winstrol in certain conditions[1].

Impact of Doping Bans

Winstrol's notorious use as a performance-enhancing drug in sports has also affected its market dynamics. The drug was banned by the International Olympic Committee and the International Amateur Athletic Federation (IAAF) in 1974 and is currently prohibited by the World Anti-Doping Agency (WADA). This has led to a negative public perception and further regulatory scrutiny[4].

Current Market Status

As of 2024, Winstrol is no longer marketed as a pharmaceutical drug in the US but can still be obtained through compounding pharmacies. Its availability is limited to a few countries, and its use is strictly regulated due to its potential for abuse and serious side effects[1][4].

Key Takeaways

  • Regulatory Challenges: Winstrol's market has been significantly impacted by regulatory restrictions and the withdrawal of its marketing authority for several indications.
  • Ownership Changes: The drug has changed hands multiple times, affecting its financial trajectory.
  • Therapeutic Limitations: The narrowing of its approved indications has reduced its market share and revenue.
  • Doping Bans: Its use as a performance-enhancing drug has led to negative public perception and further regulatory scrutiny.

FAQs

  1. What is Winstrol used for? Winstrol, or stanozolol, is primarily used to treat hereditary angioedema and has been indicated for other medical conditions such as aplastic anemia and certain vascular disorders, although its use for these conditions has been significantly restricted[1][4].

  2. Why was Winstrol withdrawn from the US market? Winstrol was withdrawn from the US market in 2010 by Lundbeck due to regulatory issues and the lack of sufficient evidence for its efficacy in many of its approved indications[1].

  3. Is Winstrol still available? Yes, Winstrol can still be obtained through compounding pharmacies in the US, although its availability is limited to a few countries[1].

  4. What are the side effects of Winstrol? Winstrol can cause a range of side effects, including liver damage, menstrual irregularities, acne, testicular atrophy, and increased risk of heart attacks and strokes[2][4].

  5. Why is Winstrol banned in sports? Winstrol is banned in sports due to its use as a performance-enhancing drug. It is prohibited by the World Anti-Doping Agency (WADA) and can result in significant penalties for athletes who test positive[4].

Sources

  1. Wikipedia - Stanozolol
  2. RxList - Winstrol (Anabolic steroids)
  3. ResearchGate - Reappraisal of the health risks associated with the use of high doses of oral and injectable androgenic steroids
  4. USADA - What is Stanozolol?
  5. Frontiers in Psychiatry - Aggression and Psychological Distress in Male and Female Anabolic-Androgenic Steroid Users

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