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Last Updated: December 22, 2024

DIENESTROL - Generic Drug Details


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

Dienestrol is the generic ingredient in three branded drugs marketed by Ortho Mcneil Pharm, Sanofi Aventis Us, and Solvay, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

Summary for DIENESTROL
US Patents:0
Tradenames:3
Applicants:3
NDAs:4
Raw Ingredient (Bulk) Api Vendors: 70
Patent Applications: 3,106
DailyMed Link:DIENESTROL at DailyMed
Medical Subject Heading (MeSH) Categories for DIENESTROL

US Patents and Regulatory Information for DIENESTROL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us DV dienestrol SUPPOSITORY;VAGINAL 083517-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ortho Mcneil Pharm DIENESTROL dienestrol CREAM;VAGINAL 006110-005 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Solvay ESTRAGUARD dienestrol CREAM;VAGINAL 084436-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sanofi Aventis Us DV dienestrol CREAM;VAGINAL 083518-001 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

DIENESTROL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dienestrol

Introduction

Dienestrol, a synthetic nonsteroidal estrogen, has been used in various medical applications, including the treatment of menopausal symptoms and certain gynecological conditions. To understand the market dynamics and financial trajectory of dienestrol, it is essential to analyze its current market position, growth drivers, challenges, and future projections.

Market Size and Growth

The estrogen receptor agonist market, which includes dienestrol, is experiencing significant growth. As of 2023, the estrogen receptor agonist market was valued at USD 4.3 billion and is expected to exceed USD 11.01 billion by 2036, growing at a CAGR of over 7.5% during the forecast period of 2024-2036[1].

Growth Drivers

Several factors are driving the growth of the market for dienestrol and other estrogen receptor agonists:

Increasing Prevalence of Cardiovascular Diseases

Cardiovascular diseases are a major cause of death globally, with approximately 17.9 million deaths per year. Estrogen receptor agonists, including dienestrol, are preferred treatments for cardiovascular diseases due to their safety profile[1].

Growing Post-Menopausal Population

By 2030, the number of post-menopausal women is projected to reach 1.2 billion globally. These women often require treatments to manage the decline in sex steroid hormones, making estrogen receptor agonists like dienestrol a crucial part of their healthcare regimen[1].

Cost Efficiency and Route of Administration

The oral segment of the estrogen receptor agonist market, which includes dienestrol, is anticipated to garner the highest revenue due to its cost efficiency and faster absorption rates compared to parenteral drugs[1].

Distribution Channels

Hospital pharmacies are expected to have noteworthy growth in the distribution of estrogen receptor agonists, including dienestrol, as most of these medications are prescribed by doctors and dispensed through hospital pharmacies[1].

Regional Market Insights

Asia Pacific

The Asia Pacific region is expected to have the highest growth in the estrogen receptor agonist market, driven by the growing geriatric population. By 2050, one in four persons in this region is expected to be older than 60, leading to increased demand for treatments like dienestrol[1].

North America

The North American market is also projected to have significant growth, driven by the rising cases of cancer and other chronic diseases that require estrogen receptor agonist treatments[1].

Clinical and Therapeutic Uses

Dienestrol is used to treat various conditions, including:

Menopausal Symptoms

Dienestrol has been used to treat menopausal symptoms in women, particularly in the United States and Europe since its introduction in the 1940s[5].

Prostate Cancer

It has also been studied for use in the treatment of prostate cancer in men through rectal administration[5].

Inflammation of the Female Reproductive System

Dienestrol is indicated for treating inflammation of the female reproductive system, showcasing its versatility in gynecological treatments[2].

Mechanism of Action

Dienestrol acts as an estrogen receptor agonist, binding to estrogen receptors (ERα and ERβ) with high affinity. It has approximately 223% and 404% of the affinity of estradiol at ERα and ERβ, respectively, making it a potent synthetic estrogen[5].

Financial Trajectory

Market Value

While the specific financial trajectory of dienestrol alone is not detailed, its inclusion in the broader estrogen receptor agonist market suggests a positive financial outlook. The market's growth from USD 4.3 billion in 2023 to USD 11.01 billion by 2036 indicates a robust financial trajectory for drugs in this category[1].

Cost and Pricing

Dienestrol, particularly in its oral form, is cost-efficient compared to parenteral drugs. This cost efficiency is a significant factor in its market growth, as it results in financial savings for patients[1].

Pharmaceutical Drug Delivery Market

The broader pharmaceutical drug delivery market, which includes estrogen receptor agonists like dienestrol, is also growing. This market was valued at USD 2.03 billion in 2022 and is expected to grow by 7% from 2023 to 2029, reaching nearly USD 3.26 billion. This growth is driven by the increased shift towards advanced drug delivery systems, which includes self-administered devices and digitalized medical equipment[3].

Challenges

Despite the positive growth drivers, there are challenges that could impact the financial trajectory of dienestrol:

Regulatory Environment

Regulatory changes and bans on certain estrogenic compounds, such as diethylstilbestrol (DES), can affect the market dynamics of related drugs like dienestrol. For instance, the EU and China have banned the addition of hormones like DES to animal feed, which could influence the broader market for synthetic estrogens[4].

Competition from Other Treatments

The market for estrogen receptor agonists is competitive, with various treatments available. The preference for other treatments could impact the demand for dienestrol.

Key Takeaways

  • The estrogen receptor agonist market, including dienestrol, is expected to grow significantly, driven by the increasing prevalence of cardiovascular diseases and the growing post-menopausal population.
  • The oral segment of this market is anticipated to garner the highest revenue due to its cost efficiency.
  • Hospital pharmacies will play a crucial role in the distribution of these medications.
  • Regional growth, particularly in the Asia Pacific and North America, will be significant.
  • Dienestrol's mechanism of action as a potent estrogen receptor agonist supports its therapeutic uses.
  • The financial trajectory is positive, with the broader market expected to grow substantially over the forecast period.

FAQs

What is the primary use of dienestrol?

Dienestrol is primarily used to treat menopausal symptoms and inflammation of the female reproductive system.

How does dienestrol act in the body?

Dienestrol acts as an estrogen receptor agonist, binding to estrogen receptors (ERα and ERβ) with high affinity.

What is the expected growth rate of the estrogen receptor agonist market?

The estrogen receptor agonist market is expected to grow at a CAGR of over 7.5% from 2024 to 2036.

Which region is expected to have the highest growth in the estrogen receptor agonist market?

The Asia Pacific region is expected to have the highest growth in the estrogen receptor agonist market due to its growing geriatric population.

What are the key distribution channels for dienestrol?

Hospital pharmacies are expected to have noteworthy growth in the distribution of dienestrol and other estrogen receptor agonists.

Sources

  1. Research Nester: Estrogen Receptor Agonist Market Forecast Report 2024-2036.
  2. DrugBank: Dienestrol: Uses, Interactions, Mechanism of Action.
  3. Maximize Market Research: Pharmaceutical Drug Delivery Market: Industry Analysis.
  4. MDPI: Research Advances in the Analysis of Estrogenic Endocrine Disrupting Compounds in Milk and Dairy Products.
  5. Wikipedia: Dienestrol.

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