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Last Updated: December 22, 2024

ESTROGENIC SUBSTANCE Drug Patent Profile


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When do Estrogenic Substance patents expire, and when can generic versions of Estrogenic Substance launch?

Estrogenic Substance is a drug marketed by Wyeth Ayerst and is included in one NDA.

The generic ingredient in ESTROGENIC SUBSTANCE is estrone. There are nine drug master file entries for this compound. Additional details are available on the estrone profile page.

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Summary for ESTROGENIC SUBSTANCE
Drug patent expirations by year for ESTROGENIC SUBSTANCE

US Patents and Regulatory Information for ESTROGENIC SUBSTANCE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wyeth Ayerst ESTROGENIC SUBSTANCE estrone INJECTABLE;INJECTION 083488-001 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

ESTROGENIC SUBSTANCE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Estrogenic Substances

Introduction

Estrogenic substances, including estrogen blockers and hormone replacement therapies (HRT) like estradiol, are crucial in the pharmaceutical market, particularly in addressing hormonal imbalances and menopausal symptoms. This article delves into the market dynamics, growth drivers, regional insights, and financial trajectory of these substances.

Market Size and Growth

Estrogen Blockers Market

The global estrogen blockers market was valued at US$ 15.02 billion in 2023 and is projected to reach US$ 23.34 billion by 2030, growing at a CAGR of 6.5% from 2023 to 2030. This growth is driven by increasing awareness about hormonal treatments and the rising incidence of breast cancer and hormonal imbalance disorders[1].

Estradiol Market

The estradiol market, particularly for gels and transdermal patches, is also experiencing significant growth. The global estradiol gel market was valued at US$ 79 million in 2023 and is anticipated to reach US$ 127 million by 2030, with a CAGR of 7.3% during the forecast period 2024-2030[3].

Drivers of Growth

Increasing Incidence of Menopausal Symptoms

The rising incidence of menopausal symptoms such as hot flashes, vaginal dryness, and mood swings is a primary driver for the estradiol market. As women live longer and remain more active, the demand for treatments that alleviate these symptoms is increasing[3].

Changing Cultural Views

Shifting cultural views toward women's health and menopause are contributing to market growth. Menopause is increasingly seen as a normal stage of life rather than a disease, leading to greater acceptance and use of HRT products[3].

Aging Population

The aging population, particularly in regions like North America, Europe, and the Asia-Pacific, is another significant factor. Countries with rapidly aging populations, such as South Korea and Japan, are expected to drive market expansion[3].

Rising Awareness of Hormonal Treatments

For estrogen blockers, the increasing awareness about hormonal treatments and the early onset of menopause are key drivers. The growing incidence of breast cancer and other hormonal imbalance disorders also boosts demand for these drugs[1].

Regional Market Dynamics

North America

North America is a well-established market for both estrogen blockers and estradiol products. The region has a high number of women experiencing menopause and a strong healthcare infrastructure that supports industry growth[1][3].

Europe

Europe also sees significant demand due to its aging population and progressive views on women's health. The region's healthcare infrastructure further supports market expansion[3].

Asia-Pacific

The Asia-Pacific region offers substantial growth opportunities, particularly in countries like South Korea and Japan. As awareness of menopausal health issues and HRT increases, the demand for estradiol products is expected to rise[3].

Financial Performance

Revenue and Sales

The financial performance of companies in the estrogenic substances market is robust. For example, the estradiol gel market is expected to grow significantly, with companies like Fuji Pharma Co., Ltd. reporting record-high consolidated sales partly due to the growth in women's healthcare products, including HRT[3].

Research and Development

Investments in research and development are driving financial growth. Companies are focusing on new products and approvals, which contribute to increased revenues and profitability. For instance, Fuji Pharma's investments in new products like FSN-013 and biosimilars have boosted their financial performance[3].

Market Restraints and Challenges

Side Effects of Estrogen Blockers

One of the significant challenges for the estrogen blockers market is the side effects associated with long-term usage, such as hot flashes, night sweats, and vaginal dryness. These side effects can hinder widespread customer acceptance[1].

Regulatory and Safety Concerns

Historical safety concerns, such as those associated with diethylstilbestrol (DES), have led to stringent regulatory oversight. DES, once prescribed to millions of women, was later found to have serious health consequences, including unusual cancers and reproductive system malformations[2].

Endocrine Disruptors

The use of certain estrogenic substances in cosmetics and other products has raised concerns about their potential as endocrine disruptors. This has led to increased scrutiny and regulatory actions, such as the EU's call for data on ingredients with potential endocrine-disrupting properties[5].

Recent Developments and Trends

Product Launch and Approval

Recent years have seen the launch and approval of several new estrogenic substances and formulations. For example, new estradiol gels and transdermal patches have been approved, offering more options for women seeking HRT[3].

Research and Collaboration

There is ongoing research and collaboration in the field of endocrine disruption and hormone therapy. Meetings and workshops, such as those held by the EPA, have been instrumental in assessing the known effects of endocrine-disrupting chemicals (EDCs) and identifying research needs[2].

Top Companies in the Market

Estrogen Blockers

Key players in the estrogen blockers market include Pfizer Inc., Novartis AG, AstraZeneca PLC, Eli Lilly and Company, Merck & Co., Inc., and others. These companies are driving innovation and growth through new product developments and strategic collaborations[1].

Estradiol

In the estradiol market, companies such as Vertical Pharmaceuticals, LLC, Meda Pharmaceutical, Ascend Therapeutics, Abbott, and Novartis are prominent. These companies are expanding their product portfolios and investing in R&D to meet the growing demand for HRT products[3].

Key Takeaways

  • The market for estrogenic substances, including estrogen blockers and estradiol, is growing significantly driven by increasing awareness of hormonal treatments and the rising incidence of menopausal symptoms.
  • Regional markets in North America, Europe, and the Asia-Pacific are key drivers of this growth.
  • Financial performance is robust, with significant revenue growth and investments in R&D.
  • Side effects and regulatory concerns remain challenges that need to be addressed.
  • Ongoing research and collaboration are crucial for the development of safer and more effective treatments.

FAQs

Q: What is the projected market size for the global estrogen blockers market by 2030? A: The global estrogen blockers market is expected to reach US$ 23.34 billion by 2030[1].

Q: What is the CAGR for the estradiol gel market from 2024 to 2030? A: The estradiol gel market is anticipated to witness a CAGR of 7.3% during the forecast period 2024-2030[3].

Q: Which regions are expected to drive the growth of the estradiol market? A: North America, Europe, and the Asia-Pacific are expected to be key drivers of the estradiol market growth[3].

Q: What are the main types of estradiol transdermal patches available in the market? A: The main types include 25 mg/day, 50 mg/day, 75 mg/day, and 100 mg/day[3].

Q: What are the primary drivers of the estradiol market growth? A: The primary drivers include the increasing incidence of menopausal symptoms, changing cultural views toward women's health, and an aging population[3].

Sources

  1. Coherent Market Insights: Estrogen Blockers Market Size, Trends and Forecast to 2030.
  2. Oxford University Press: Minireview: Endocrine Disruptors: Past Lessons and Future Directions.
  3. Drug Patent Watch: Generic ESTRADIOL INN entry, drug patent expiration information.
  4. PubMed: Estrogens and progestins: background and history, trends in use.
  5. Frontiers in Cell and Developmental Biology: An extensive review on phenolic compounds and their potential.

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