You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

ETHYLESTRENOL - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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

Ethylestrenol is the generic ingredient in one branded drug marketed by Organon Usa Inc and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for ETHYLESTRENOL
US Patents:0
Tradenames:1
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 12
Patent Applications: 1,418
DailyMed Link:ETHYLESTRENOL at DailyMed
Medical Subject Heading (MeSH) Categories for ETHYLESTRENOL

US Patents and Regulatory Information for ETHYLESTRENOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Organon Usa Inc MAXIBOLIN ethylestrenol ELIXIR;ORAL 014006-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Organon Usa Inc MAXIBOLIN ethylestrenol TABLET;ORAL 014005-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

ETHYLESTRENOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ethylestrenol

Introduction

Ethylestrenol, an androgen and anabolic steroid (AAS), has had a complex and evolving presence in the pharmaceutical market. Initially introduced for various medical indications, its use has been significantly curtailed due to several factors. Here, we delve into the market dynamics and financial trajectory of ethylestrenol.

Historical Use and Indications

Ethylestrenol was first described in 1959 and introduced for medical use in 1961. It was marketed under several brand names, including Maxibolin, Orabolin, and others. The drug was used to promote weight gain, treat anemia and osteoporosis, and as an adjunct in various catabolic states and chronic conditions[1].

Medical Uses and Efficacy

Ethylestrenol was utilized for a range of medical purposes, including promoting muscle growth, treating bone pain associated with osteoporosis, and managing treatment-refractory anemias. However, its efficacy as a muscle-builder was considered weak compared to other AAS, which limited its popularity for such purposes[1].

Side Effects and Safety Concerns

The drug is associated with several side effects, including symptoms of masculinization such as acne, increased hair growth, voice changes, and increased sexual desire. It also poses a risk of liver damage, a common concern with 17α-alkylated AAS like ethylestrenol[1].

Market Availability and Regulatory Status

Ethylestrenol's availability is highly restricted. It is no longer used in humans and is only available for veterinary use in Australia and New Zealand. This limited availability significantly impacts its market dynamics and financial performance[1].

Financial Performance and Revenue

Given its discontinued use in humans and limited veterinary applications, the financial trajectory of ethylestrenol is not robust. The revenue generated from this drug is minimal and largely confined to veterinary markets in specific regions. Unlike newer drugs that drive significant revenue through market penetration and exclusivity periods, ethylestrenol's contribution to pharmaceutical company revenues is negligible[3].

Comparison with Other Anabolic Steroids

Ethylestrenol's market performance can be contrasted with other anabolic steroids that are still in use. For instance, trenbolone acetate, used in animals to stimulate muscle growth and appetite, continues to have a more significant market presence despite its own set of side effects and regulatory issues[4].

Impact of Regulatory Changes

Regulatory changes and the classification of ethylestrenol as a controlled substance in many countries have further diminished its market viability. The illicit use of such substances is strictly prohibited, which has led to a decline in any potential black market revenue that might have otherwise existed[1].

Pharmaceutical Company Strategies

Pharmaceutical companies have shifted their focus towards newer, more profitable drugs. The revenue growth in the pharmaceutical industry is largely driven by new products, especially those with exclusivity periods. Ethylestrenol, being an older drug with limited use, does not fit into this strategy and thus does not contribute significantly to the revenue of pharmaceutical companies[3].

Market Penetration and Competition

The market for anabolic steroids is highly competitive, with newer and more effective drugs capturing the majority of the market share. Ethylestrenol's weak muscle-building effects and significant side effects make it less competitive compared to other AAS, further reducing its market penetration[1].

Future Outlook

Given the current regulatory landscape and the limited use of ethylestrenol, its future financial trajectory is unlikely to improve. The drug will likely remain a niche product with minimal revenue generation, confined to specific veterinary applications in a few countries.

Key Takeaways

  • Limited Availability: Ethylestrenol is only available for veterinary use in Australia and New Zealand.
  • Weak Efficacy: It is considered a weak muscle-builder compared to other AAS.
  • Regulatory Restrictions: Classified as a controlled substance in many countries.
  • Minimal Revenue: Contributes negligibly to pharmaceutical company revenues.
  • Competitive Market: Outcompeted by newer and more effective anabolic steroids.

FAQs

  1. What is ethylestrenol used for? Ethylestrenol was used to promote weight gain, treat anemia and osteoporosis, and as an adjunct in various catabolic states and chronic conditions. It is now only used for veterinary purposes in Australia and New Zealand.

  2. Why was ethylestrenol discontinued for human use? Ethylestrenol was discontinued due to its weak efficacy as a muscle-builder and significant side effects, including liver damage and symptoms of masculinization.

  3. What are the side effects of ethylestrenol? Side effects include acne, increased hair growth, voice changes, increased sexual desire, and liver damage.

  4. Is ethylestrenol a controlled substance? Yes, ethylestrenol is classified as a controlled substance in many countries, making its non-medical use illicit.

  5. How does ethylestrenol compare to other anabolic steroids in terms of market presence? Ethylestrenol has a significantly reduced market presence compared to other anabolic steroids due to its limited use, weak efficacy, and regulatory restrictions.

Sources

  1. Wikipedia: Ethylestrenol.
  2. Congressional Record: Congressional Record - Congress.gov.
  3. Yale SOM Security Analysis: Pharmaceutical Resources, Inc. (PRX) - Yale SOM Security Analysis.
  4. MDPI: Medicinal Use of Testosterone and Related Steroids Revisited.

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.