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Last Updated: December 22, 2024

ESTROGENS, ESTERIFIED - Generic Drug Details


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What are the generic drug sources for estrogens, esterified and what is the scope of patent protection?

Estrogens, esterified is the generic ingredient in six branded drugs marketed by Bristol Myers Squibb, Pvt Form, Sandoz, Solvay, Roche Palo, and Monarch Pharms, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for ESTROGENS, ESTERIFIED
US Patents:0
Tradenames:6
Applicants:6
NDAs:18
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 109
Clinical Trials: 5
Patent Applications: 7,042
What excipients (inactive ingredients) are in ESTROGENS, ESTERIFIED?ESTROGENS, ESTERIFIED excipients list
DailyMed Link:ESTROGENS, ESTERIFIED at DailyMed
Recent Clinical Trials for ESTROGENS, ESTERIFIED

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

SponsorPhase
Stanley Medical Research InstitutePhase 2
The AlfredPhase 2
Solvay PharmaceuticalsPhase 2

See all ESTROGENS, ESTERIFIED clinical trials

US Patents and Regulatory Information for ESTROGENS, ESTERIFIED

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pvt Form FEMOGEN estrogens, esterified TABLET;ORAL 085076-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Roche Palo EVEX estrogens, esterified TABLET;ORAL 083376-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bristol Myers Squibb AMNESTROGEN estrogens, esterified TABLET;ORAL 083266-004 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

ESTROGENS, ESTERIFIED Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Esterified Estrogens

Introduction

Esterified estrogens, a type of hormone therapy, play a significant role in the treatment of menopausal symptoms and related health issues. Understanding the market dynamics and financial trajectory of these drugs is crucial for pharmaceutical companies, investors, and healthcare providers.

Historical Context of Estrogen Therapy

Estrogen therapy has a long history, with conjugated equine estrogens (CEE) being approved by the FDA in 1942. The use of estrogens saw significant fluctuations over the years due to concerns about side effects, particularly the increased risk of endometrial cancer and cardiovascular events[4].

Market Size and Growth

The global menopause treatment market, which includes esterified estrogens, is projected to grow substantially. As of 2023, the market is valued at approximately $15.21 billion and is expected to reach $24.33 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.9%[3].

Drivers of Market Growth

Several factors are driving the growth of the menopause treatment market, including:

Increasing Geriatric Population

The global population is aging, leading to an increase in the number of postmenopausal women who may require hormone therapy[3].

Growing Awareness and Conversation Around Menopause

Greater awareness and open discussion about menopause symptoms have increased the demand for effective treatment options[3].

Rising Prevalence of Early Menopause

Early menopause, occurring before the age of 40, is becoming more common due to lifestyle factors such as stress, unhealthy diets, and smoking. This has raised the demand for menopause treatment options[3].

Segmentation of the Market

The menopause treatment market is segmented by treatment type, route of administration, form, indication, and distribution channel.

By Treatment Type

Hormone therapy, particularly estrogen-based drugs, remains the most favored treatment option. Esterified estrogens fall under this category and are often prescribed for their therapeutic benefits[3].

By Route of Administration

The oral segment dominates the market due to ease of use, and esterified estrogens are commonly administered orally[3].

Financial Trajectory

The financial trajectory of esterified estrogens is closely tied to the overall menopause treatment market.

Revenue Forecast

The market revenue is expected to increase significantly from $15.21 billion in 2023 to $24.33 billion by 2031. This growth is driven by the increasing demand for effective menopause treatments and the development of new, innovative products[3].

Key Players

Major pharmaceutical companies such as Novartis AG, Pfizer Inc., Bayer AG, and others are investing heavily in research and development to create advanced treatment solutions. These investments are expected to drive innovation and growth in the market[3].

Challenges and Restraints

Despite the growth potential, there are several challenges and restraints affecting the market:

Side Effects of HRT Drugs

The use of hormone therapy, including esterified estrogens, is associated with several side effects such as increased risks of myocardial infarction, stroke, and endometrial cancer. These risks have led to a reevaluation of hormone therapy and the development of alternative treatments[5].

High Cost of Treatment

The cost of hormone therapy can be prohibitive for some patients, limiting access to these treatments[3].

Clinical Studies and Safety Profile

Clinical studies have provided valuable insights into the safety and efficacy of esterified estrogens.

Bone Mineral Density

Studies have shown that esterified estrogens at doses from 0.3 to 1.25 mg/day can significantly increase bone mineral density of the lumbar spine, reducing the risk of osteoporosis[2].

Lipid Changes and Endometrial Hyperplasia

Esterified estrogens also produce positive changes in lipid levels, but higher doses can lead to endometrial hyperplasia, a risk that needs to be managed with appropriate medical supervision[2].

Cardiovascular Risks

The Women's Health Initiative (WHI) study highlighted increased risks of cardiovascular events, such as myocardial infarction and stroke, associated with combined estrogen and progestin therapy. However, the risk profile can vary depending on the type of estrogen and the presence of progestin[5].

Market Trends

Several trends are shaping the market for esterified estrogens:

Dominance of Oral Segment

The oral route of administration remains the most popular due to its ease of use and patient compliance[3].

Development of New Formulations

Pharmaceutical companies are developing new formulations, including bioidentical hormones and alternative treatment methods, to offer more options with minimal side effects[3].

Regional Market Dynamics

North America is expected to hold a dominant position in the market due to high healthcare expenditure and awareness levels in the region[3].

Key Takeaways

  • The global menopause treatment market, including esterified estrogens, is projected to grow significantly.
  • Increasing awareness, a rising geriatric population, and the prevalence of early menopause are driving market growth.
  • Despite growth, the market faces challenges such as side effects and high treatment costs.
  • Clinical studies highlight the therapeutic benefits and risks associated with esterified estrogens.
  • Pharmaceutical companies are investing in R&D to develop innovative and safer treatment options.

FAQs

  1. What is the projected growth rate of the global menopause treatment market? The global menopause treatment market is expected to grow at a CAGR of 5.9% from 2023 to 2031[3].

  2. What are the main drivers of the menopause treatment market? The main drivers include the increasing geriatric population, growing awareness about menopause symptoms, and the rising prevalence of early menopause[3].

  3. What are the common side effects associated with esterified estrogens? Common side effects include increased risks of myocardial infarction, stroke, endometrial cancer, and endometrial hyperplasia[2][5].

  4. Which route of administration dominates the market for esterified estrogens? The oral route of administration dominates the market due to its ease of use[3].

  5. What is the impact of the Women's Health Initiative (WHI) study on hormone therapy? The WHI study reported increased risks of cardiovascular events and other health issues associated with combined estrogen and progestin therapy, leading to a reevaluation of hormone therapy and increased interest in alternative treatments[5].

Sources

  1. Esterified Estrogen and Conjugated Equine Estrogen and the Risk of Myocardial Infarction and Stroke - JAMA Internal Medicine[1]
  2. Low-dose esterified estrogen therapy: effects on bone, plasma lipids, and endometrial tissue - PubMed[2]
  3. Global Menopause Treatment Market Set to reach $24.33 Billion by 2031 - GlobeNewswire[3]
  4. Estrogens and progestins: background and history, trends in use - PubMed[4]
  5. MENEST® (esterified estrogens) Patient information - Pfizer Medical Information[5]

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