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Last Updated: December 22, 2024

ESTERIFIED ESTROGENS Drug Patent Profile


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When do Esterified Estrogens patents expire, and when can generic versions of Esterified Estrogens launch?

Esterified Estrogens is a drug marketed by Pvt Form and Sandoz and is included in four NDAs.

The generic ingredient in ESTERIFIED ESTROGENS is estrogens, esterified. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the estrogens, esterified profile page.

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Summary for ESTERIFIED ESTROGENS
US Patents:0
Applicants:2
NDAs:4
Clinical Trials: 5
DailyMed Link:ESTERIFIED ESTROGENS at DailyMed
Drug patent expirations by year for ESTERIFIED ESTROGENS
Recent Clinical Trials for ESTERIFIED ESTROGENS

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

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

See all ESTERIFIED ESTROGENS clinical trials

US Patents and Regulatory Information for ESTERIFIED ESTROGENS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pvt Form ESTERIFIED ESTROGENS estrogens, esterified TABLET;ORAL 083414-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sandoz ESTERIFIED ESTROGENS estrogens, esterified TABLET;ORAL 085302-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pvt Form ESTERIFIED ESTROGENS estrogens, esterified TABLET;ORAL 083765-001 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

ESTERIFIED ESTROGENS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Esterified Estrogens

Market Overview

The market for esterified estrogens, a type of hormone replacement therapy (HRT), is part of the broader hormone replacement therapy market, which is experiencing significant growth. Here are the key dynamics and financial trajectories for esterified estrogens.

Global Market Size and Growth

The global hormone replacement therapy market, which includes esterified estrogens, is projected to grow from $16.91 billion in 2024 to $27.52 billion by 2032, at a Compound Annual Growth Rate (CAGR) of 6.3%[1].

Product Segment and Revenue

Esterified estrogens, sold under brand names such as Estratab and Menest, are a significant part of this market. These medications are used for hormone therapy in menopausal symptoms, low sex hormone levels, and in the treatment of certain cancers. The revenue generated by these products is substantial, with esterified estrogens contributing to the overall growth of the HRT market[4].

Routes of Administration

The market for esterified estrogens is influenced by various routes of administration. The oral route currently holds the largest market share due to the widespread adoption of oral drugs globally. However, the transdermal segment, which includes new gel formulations and sprays, is anticipated to register a significant CAGR during the forecast period. This shift is driven by the introduction of products like Lenzetto (estradiol spray) and Estrasorb, which offer effective treatment with minimal risks[1].

Regional Insights

North America

The North American market is a dominant force in the global HRT market, driven by the high prevalence of menopause and growth hormone deficiency disorders, along with high awareness and regulatory approvals. For instance, the market size in North America stood at $8.35 billion in 2023 and is expected to continue growing due to robust healthcare expenditure and the availability of advanced products[1].

Asia Pacific

The Asia Pacific region is emerging as a significant contributor to the market, with the highest CAGR expected in the near future. Factors such as increasing awareness about post-menopausal hazards, rising unmet medical needs, changes in reimbursement policies, and ongoing R&D programs are driving this growth[1].

Competitive Landscape

Key players in the HRT market, including Novo Nordisk A/S and Pfizer Inc., dominate the segment for esterified estrogens. Novo Nordisk, with its popular product Norditropin, holds a significant market share. Pfizer Inc., with its focus on developing HRT therapies and products like Genotropin, also plays a crucial role in the market[1].

Clinical Efficacy and Safety

Esterified estrogens have been shown to produce positive changes on bone mineral density and lipid levels. Studies have demonstrated that doses from 0.3 to 1.25 mg/day can increase bone mineral density of the lumbar spine and improve lipid profiles. However, higher doses are associated with risks such as endometrial hyperplasia and other side effects[2].

Side Effects and Risks

The use of esterified estrogens is associated with several side effects, including nausea, breast tension, edema, and breakthrough bleeding. Long-term use, especially unopposed by progestin, can increase the risk of endometrial cancer and venous thromboembolism. The Women's Health Initiative study highlighted increased risks of myocardial infarctions, strokes, and invasive breast cancer with estrogen plus progestin therapy[5].

Market Drivers

Increasing Awareness and Prevalence

The rising awareness about hormonal treatments and the increasing incidence of menopause and growth hormone deficiency disorders are key drivers of the market. Early menopause and hormonal imbalance disorders also contribute to the demand for esterified estrogens[3].

Regulatory Approvals and New Formulations

The launch of new formulations, such as estradiol gels and sprays, and regulatory approvals for these products are driving market growth. For example, the FDA approval for percutaneous estradiol gel and the launch of Lenzetto (estradiol spray) in the U.K. have expanded treatment options and improved patient compliance[1].

Healthcare Expenditure

Robust healthcare expenditure in regions like North America and the increasing availability of advanced products are also boosting the market. The rise in the number of pharmacies and drug stores, particularly in the U.S., ensures a rapid supply of these drugs, further contributing to market growth[1].

Financial Projections

Given the overall growth of the HRT market, esterified estrogens are expected to contribute significantly to the financial trajectory. Here are some key financial projections:

  • Market Size: The global HRT market, which includes esterified estrogens, is projected to reach $27.52 billion by 2032 from $16.91 billion in 2024[1].
  • CAGR: The market is expected to grow at a CAGR of 6.3% during the forecast period[1].
  • Regional Growth: North America will continue to dominate, while the Asia Pacific region will emerge as a significant contributor with the highest CAGR[1].

Key Takeaways

  • The global HRT market, including esterified estrogens, is projected to grow significantly by 2032.
  • The oral route of administration currently dominates, but transdermal segments are gaining traction.
  • North America is the leading market, with the Asia Pacific region showing high growth potential.
  • Key players like Novo Nordisk and Pfizer Inc. are driving the market with their diverse product portfolios.
  • Clinical efficacy and safety profiles of esterified estrogens are crucial for market acceptance.
  • Regulatory approvals and new formulations are key drivers of market growth.

FAQs

What is the projected market size for the global HRT market by 2032?

The global HRT market is projected to grow from $16.91 billion in 2024 to $27.52 billion by 2032[1].

Which region dominates the HRT market?

North America currently dominates the HRT market, driven by high prevalence and awareness of menopause and growth hormone deficiency disorders[1].

What are the common side effects of esterified estrogens?

Common side effects include nausea, breast tension, edema, and breakthrough bleeding. Long-term use can increase the risk of endometrial cancer and venous thromboembolism[5].

Which companies are key players in the HRT market?

Novo Nordisk A/S and Pfizer Inc. are among the key players, with Novo Nordisk holding a significant market share due to its popular product Norditropin[1].

What are the drivers of the esterified estrogens market?

Increasing awareness about hormonal treatments, rising incidence of menopause and growth hormone deficiency disorders, and regulatory approvals for new formulations are key drivers[1][3].

How do transdermal formulations impact the market?

Transdermal formulations, such as estradiol gels and sprays, are expected to register a significant CAGR due to their effectiveness and minimal risks, improving patient compliance and market growth[1].

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