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Last Updated: December 22, 2024

ESTRONE - Generic Drug Details


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

Estrone is the generic ingredient in four branded drugs marketed by Wyeth Ayerst, Dr Reddys, Watson Labs, and Parkedale, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for estrone.

Summary for ESTRONE
Recent Clinical Trials for ESTRONE

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

SponsorPhase
Science Valley Research InstituteN/A
Biòs FarmacêuticaN/A
University of Maryland, BaltimoreEarly Phase 1

See all ESTRONE clinical trials

Medical Subject Heading (MeSH) Categories for ESTRONE

US Patents and Regulatory Information for ESTRONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs NATURAL ESTROGENIC SUBSTANCE-ESTRONE estrone INJECTABLE;INJECTION 085237-001 Nov 23, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Parkedale THEELIN estrone INJECTABLE;INJECTION 003977-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Wyeth Ayerst ESTROGENIC SUBSTANCE estrone INJECTABLE;INJECTION 083488-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Parkedale THEELIN estrone INJECTABLE;INJECTION 003977-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs ESTRONE estrone INJECTABLE;INJECTION 083397-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Parkedale THEELIN estrone INJECTABLE;INJECTION 003977-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys ESTRONE estrone INJECTABLE;INJECTION 085239-001 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

ESTRONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Estrone

Introduction to Estrone

Estrone, a naturally occurring estrogen, is widely used in the treatment of various symptoms associated with menopause and other hormonal imbalances. Its market dynamics are influenced by several factors, including demographic changes, advancements in pharmaceutical technology, and regulatory environments.

Market Growth and CAGR

The global estrone market is anticipated to experience significant growth over the forecast period. It is expected to register a Compound Annual Growth Rate (CAGR) of 3.76% from 2024 to 2032[1].

Key Drivers of the Estrone Market

Increasing Demand for Hormone Replacement Therapy (HRT)

The growing incidence of menopause-related conditions is a major driver for the estrone market. As the global population ages, more women are seeking treatment for age-related hormonal imbalances, driving the demand for HRT, including estrone[1].

Advancements in Pharmaceutical Technologies

Innovative drug delivery systems such as transdermal patches and controlled-release formulations are making estrone more effective and accessible. These advancements are enhancing the adoption of estrone-based therapies[1].

Rising Awareness and Focus on Women's Health

Increased awareness and focus on women's health, particularly in managing menopausal symptoms, are leading to higher demand for estrone-based treatments. This trend is more pronounced in emerging economies where healthcare infrastructure is improving[1].

Favorable Regulatory Environments

Favorable regulatory environments and approvals for new estrone formulations are facilitating market growth. Regulatory support is crucial for the introduction and widespread adoption of new estrone products[1].

Market Restraints

Potential Side Effects and Health Risks

The potential side effects and health risks associated with estrone use, such as an increased risk of breast cancer and cardiovascular issues, may limit its adoption. These risks can deter some patients from opting for estrone-based treatments[1].

Alternative Therapies

The presence of alternative therapies, including bioidentical hormones and non-hormonal treatments, can reduce the demand for estrone. Patients may prefer these alternatives due to perceived lower risks or different efficacy profiles[1].

High Costs

The high costs associated with estrone-based treatments can be a significant barrier, especially in low-income regions. This cost factor can limit market penetration in certain geographic areas[1].

Market Segmentation

Application Outlook

  • Menopausal Therapy: Estrone is widely used to manage symptoms like hot flashes and osteoporosis in postmenopausal women.
  • Osteoporosis Prevention: Estrone helps in maintaining bone density, reducing the risk of osteoporosis.
  • Urinary Incontinence: It is used to treat urinary incontinence associated with menopause.
  • Postmenopausal Vulvovaginal Symptoms: Estrone is effective in treating vaginal dryness and dyspareunia[1].

Dosage Form Outlook

  • Oral: Available in tablet or capsule form.
  • Transdermal: Transdermal patches are a popular delivery method.
  • Vaginal: Creams, suppositories, and rings are used for localized treatment.
  • Injectable: Less common but used in specific cases[1].

Distribution Channel Outlook

  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies

These channels play a crucial role in the accessibility and distribution of estrone products[1].

Geographical Insights

The estrone market is expanding in emerging economies due to improving healthcare infrastructure and increased access to hormone therapies. Regions such as North America, Europe, and Asia-Pacific are significant markets due to their large patient populations and advanced healthcare systems[1].

Key Companies in the Estrone Market

Major players in the estrone market include:

  • Merck Co., Inc.
  • Novartis AG
  • Cipla
  • Abbott Laboratories
  • Lupin Limited
  • Zydus Pharmaceuticals Ltd.
  • GlaxoSmithKline plc
  • Johnson & Johnson
  • Teva Pharmaceutical Industries Ltd.
  • Pfizer Inc.
  • Roche Holding AG
  • Aspen Pharmacare Holdings Limited
  • Sanofi S.A.
  • AstraZeneca plc
  • Bayer AG[1].

Financial Trajectory

The global estrone market is expected to grow substantially over the next few years. Here are some key financial highlights:

  • Market Size: The market is anticipated to grow at a CAGR of 3.76% from 2024 to 2032, indicating a steady increase in market size[1].
  • Revenue Projections: While specific revenue figures for the estrone market are not provided, the overall estrogen market, which includes estrone, is expected to see significant growth. For example, the estrogen blockers market, which is related but distinct, is projected to reach US$ 23.34 billion by 2030 from US$ 15.02 billion in 2023, growing at a CAGR of 6.5%[3].

Research and Development

Ongoing research and development in pharmaceutical technologies are crucial for the estrone market. These efforts are focused on improving the efficacy and delivery of estrone, which in turn enhances its adoption. For instance, the use of estrone in compounded products, as nominated for inclusion on the 503B Bulks List, highlights the ongoing interest in optimizing its clinical use[2].

Clinical Use and Indications

Estrone is used to treat a variety of symptoms associated with menopause, including vasomotor symptoms (hot flashes), vulvovaginal atrophy, vaginal dryness, and dyspareunia. It is administered through various routes such as oral, mucosal, topical, and vaginal, in different dosage forms like capsules, suspensions, creams, and suppositories[2].

"Estrone was nominated for inclusion on the 503B Bulks list to treat symptoms associated with menopause such as vasomotor symptoms (hot flashes), vulvovaginal atrophy, vaginal dryness, and dyspareunia via a variety of administration methods and dosage forms."[2]

Key Takeaways

  • The estrone market is driven by the increasing demand for HRT, advancements in pharmaceutical technologies, and rising awareness of women's health.
  • The market faces restraints such as potential side effects, alternative therapies, and high costs.
  • The market is segmented based on application, dosage form, and distribution channels.
  • Key companies are investing in research and development to improve the efficacy and delivery of estrone.
  • The market is expected to grow at a CAGR of 3.76% from 2024 to 2032.

Frequently Asked Questions (FAQs)

1. What are the primary uses of estrone in medical treatment?

Estrone is primarily used to treat symptoms associated with menopause, such as hot flashes, osteoporosis, urinary incontinence, and postmenopausal vulvovaginal symptoms[1].

2. What are the key drivers of the estrone market?

The key drivers include the growing incidence of menopause-related conditions, advancements in pharmaceutical technologies, and rising awareness and focus on women's health[1].

3. What are the potential side effects of estrone?

Potential side effects include an increased risk of breast cancer and cardiovascular issues, which can limit its adoption[1].

4. How is the estrone market segmented?

The market is segmented based on application (menopausal therapy, osteoporosis prevention, etc.), dosage form (oral, transdermal, vaginal), and distribution channels (hospital pharmacies, retail pharmacies, online pharmacies)[1].

5. Which companies are major players in the estrone market?

Major players include Merck Co., Inc., Novartis AG, Cipla, Abbott Laboratories, and others[1].

Cited Sources:

  1. OpenPR: Estrone Market Size, Top Players, Trends, Growth Dynamics and Industry Forecast 2032.
  2. University of Maryland, Baltimore: Summary Report Estrone Prepared for: Food and Drug Administration.
  3. Coherent Market Insights: Estrogen Blockers Market Size, Trends and Forecast to 2030.
  4. Market Research Intellect: Global estrone market size and forecast.
  5. DrugBank Online: Estrone: Uses, Interactions, Mechanism of Action.

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