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Last Updated: April 21, 2025

Dromostanolone propionate - Generic Drug Details


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What are the generic drug sources for dromostanolone propionate and what is the scope of freedom to operate?

Dromostanolone propionate is the generic ingredient in one branded drug marketed by Lilly and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for dromostanolone propionate.

Summary for dromostanolone propionate

US Patents and Regulatory Information for dromostanolone propionate

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Lilly DROLBAN dromostanolone propionate INJECTABLE;INJECTION 012936-001 Approved Prior to Jan 1, 1982 DISCN No 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

Market Dynamics and Financial Trajectory for Dromostanolone Propionate

Introduction

Dromostanolone propionate, also known as drostanolone propionate, is a synthetic androgenic anabolic steroid that has been used in various medical and non-medical contexts. This article will delve into the market dynamics and financial trajectory of this pharmaceutical drug, exploring its historical use, current market status, and the factors influencing its financial performance.

Historical Use and Medical Applications

Dromostanolone propionate was initially introduced in the early 1970s and was primarily used to treat breast cancer in women. It was valued for its moderate anabolic effects and weak androgenic effects, making it suitable for female patients who were at risk of virilization from stronger androgens[1][2].

Mechanism of Action

The drug works by interacting with the androgen receptor (AR), leading to increased protein synthesis and decreased amino acid degradation. It also reduces or inhibits prolactin and estrogen receptors in the breasts, which is linked to its antitumor effects. As a derivative of dihydrotestosterone (DHT), it does not convert into estrogen and has anti-estrogenic properties[1][2].

Market Status

Dromostanolone propionate is no longer marketed and has been withdrawn from the pharmaceutical market. It was previously available in several countries, including the United States, Europe, and Japan, but its production and distribution have ceased[1].

Financial Trajectory

Given that dromostanolone propionate is no longer marketed, its financial trajectory is largely historical. Here are some key points:

Revenue and Sales

During its active marketing period, the revenue generated by dromostanolone propionate would have been significant, particularly in the context of treating breast cancer and other medical conditions. However, with its withdrawal from the market, any revenue streams associated with this drug have ceased.

Production Costs

The production costs of dromostanolone propionate would have included the costs of raw materials, manufacturing, and distribution. Since the drug is no longer produced, these costs are no longer incurred.

Competitive Landscape

In the pharmaceutical market, competition is fierce, especially in the oncology segment. Other drugs and treatments have likely filled the gap left by dromostanolone propionate, offering alternative or more advanced therapies for breast cancer and other conditions. The competitive landscape has moved on, with newer drugs and technologies gaining prominence[3].

Non-Medical Uses and Black Market Impact

Dromostanolone propionate has also been used for physique- and performance-enhancing purposes by athletes and bodybuilders. This non-medical use could have contributed to a black market demand, although the financial impact of this is difficult to quantify and would not be reflected in official market data[1][2].

Regulatory and Legal Status

Dromostanolone propionate, like other anabolic androgenic steroids (AAS), is a schedule III controlled substance in the United States under the Controlled Substances Act. This regulatory status affects its availability and use, further impacting its financial trajectory[1].

Impact of Digital Transformation and Innovation

While dromostanolone propionate itself is not benefiting from current trends in digital transformation and innovation, the broader pharmaceutical industry is undergoing significant changes. Advances in genomics, biomarkers, and artificial intelligence are driving new therapeutic solutions and improving patient outcomes. These innovations could lead to the development of more effective and targeted treatments, potentially reducing the need for older drugs like dromostanolone propionate[3].

Pricing and Access Issues

The life sciences industry is facing significant challenges related to pricing and access to drugs. The expiration of patents on high-revenue products and the rise of generic drugs and biosimilars are key trends affecting the industry's financial landscape. However, these issues are more relevant to currently marketed drugs rather than those that have been withdrawn like dromostanolone propionate[3][4].

Conclusion

Dromostanolone propionate's market dynamics and financial trajectory are characterized by its historical use, withdrawal from the market, and the absence of current revenue streams. The drug's unique properties and medical applications once made it valuable, but its non-medical use and regulatory status have also played significant roles. As the pharmaceutical industry continues to evolve with new technologies and innovations, the legacy of drugs like dromostanolone propionate serves as a reminder of the dynamic nature of the market.

Key Takeaways

  • Historical Use: Dromostanolone propionate was used to treat breast cancer and had moderate anabolic and weak androgenic effects.
  • Market Withdrawal: The drug is no longer marketed and has been withdrawn from the pharmaceutical market.
  • Financial Impact: The withdrawal has ceased any revenue streams associated with the drug.
  • Non-Medical Use: It has been used for physique- and performance-enhancing purposes, contributing to a black market demand.
  • Regulatory Status: Classified as a schedule III controlled substance in the United States.
  • Industry Trends: The pharmaceutical industry is evolving with digital transformation, innovation, and changes in pricing and access to drugs.

FAQs

1. What was the primary medical use of dromostanolone propionate? Dromostanolone propionate was primarily used to treat breast cancer in women.

2. Why is dromostanolone propionate no longer marketed? The exact reasons for its withdrawal are not specified, but it is no longer available in the market.

3. What are the side effects of dromostanolone propionate? Side effects include symptoms of masculinization such as acne, increased hair growth, voice changes, and increased sexual desire. High doses and long-term use can lead to more severe virilization.

4. How does dromostanolone propionate compare to other anabolic steroids? It has a mild side effect profile compared to other AAS, making it suitable for use in women, and it does not convert into estrogen.

5. What is the current regulatory status of dromostanolone propionate? It is classified as a schedule III controlled substance in the United States under the Controlled Substances Act.

Sources

  1. Wikipedia: Drostanolone propionate
  2. Iron-Daddy: Drostanolone Propionate | Masteron Propionate Bodybuilding
  3. Deloitte Insights: 2025 life sciences outlook
  4. NBER: The Economics of Drug Development: Pricing and Innovation in a Changing Market
  5. PharmaCompass: Dromostanolone Propionate | Drug Information, Uses, Side Effects

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