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Last Updated: March 17, 2025

Dydrogesterone - Generic Drug Details


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

Dydrogesterone is the generic ingredient in one branded drug marketed by Solvay and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for dydrogesterone.

Summary for dydrogesterone
Recent Clinical Trials for dydrogesterone

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

SponsorPhase
Bezmialem Vakif UniversityN/A
Zagazig UniversityN/A
El Shatby University Hospital for Obstetrics and GynecologyPhase 2/Phase 3

See all dydrogesterone clinical trials

Medical Subject Heading (MeSH) Categories for dydrogesterone

US Patents and Regulatory Information for dydrogesterone

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Solvay GYNOREST dydrogesterone TABLET;ORAL 017388-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Solvay GYNOREST dydrogesterone TABLET;ORAL 017388-002 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 2 of 2 entries

Market Dynamics and Financial Trajectory for Dydrogesterone

Introduction to Dydrogesterone

Dydrogesterone, also known as Isopregnenone, is a synthetic progestogen widely used in the treatment of various reproductive health issues, including dysfunctional bleeding, premenstrual syndrome, dysmenorrhea, threatened miscarriage, and irregular cycles. The drug has been gaining significant traction in the global pharmaceutical market due to its efficacy and the rising awareness of women's health.

Global Market Size and Growth

The global Dydrogesterone market is experiencing substantial growth, driven by several key factors. As of 2024, the global Dydrogesterone market size is estimated to be USD 942.5 million. This market is projected to expand significantly, reaching USD 1,813.41 million by 2031, with a Compound Annual Growth Rate (CAGR) of 9.80% from 2024 to 2031[1][4].

Regional Market Analysis

North America

North America currently dominates the Dydrogesterone market, holding more than 40% of the global revenue with a market size of USD 377 million in 2024. This region is expected to grow at a CAGR of 8% from 2024 to 2031, driven by high awareness of women's health issues and advanced healthcare infrastructure[1].

Europe

Europe holds the second-largest market share, accounting for more than 30% of the global revenue with a market size of USD 282.75 million in 2024. The European market is expected to grow at a CAGR of 8.3% from 2024 to 2031[1].

Asia Pacific

The Asia Pacific region is another significant market, holding around 23% of the global revenue with a market size of USD 216.78 million in 2024. This region is expected to grow at a higher CAGR of 11.8% from 2024 to 2031, driven by increasing healthcare infrastructure and awareness of women's health[1].

Latin America and Middle East & Africa

Latin America and the Middle East & Africa also contribute to the global market, with market sizes of USD 47.13 million and USD 18.85 million in 2024, respectively. These regions are expected to grow at CAGRs of 9.2% and 9.5% from 2024 to 2031[1].

Key Drivers of the Market

Increasing Awareness of Women's Health

The rising awareness of women's health issues and the increasing prevalence of hormonal disorders such as endometriosis and polycystic ovary syndrome (PCOS) are significant drivers of the Dydrogesterone market[1].

Advancements in Healthcare Infrastructure

Improvements in healthcare infrastructure enhance access to treatments, contributing to the market's growth. Advanced healthcare facilities and well-established pharmaceutical industries in regions like North America further support this growth[1].

Supportive Regulatory Environments

Favorable regulatory environments that encourage the development of Dydrogesterone formulations also play a crucial role in the market's expansion[1].

Ongoing Research and Development

Continuous research into the efficacy and safety of Dydrogesterone for managing reproductive health conditions is fostering further interest and adoption of the drug[1].

Emerging Trends

Personalized Medicine

There is a growing emphasis on personalized medicine, which tailors treatments to individual patient needs. This trend is expected to increase the demand for Dydrogesterone as healthcare providers seek more targeted and effective treatments[1].

Telehealth Services

The integration of telehealth services is allowing for greater patient engagement and education regarding hormonal therapies. This trend is particularly significant in the post-COVID-19 era, where remote healthcare services have become more prevalent[1].

Market Challenges and Barriers

COVID-19 Impact

The COVID-19 pandemic had a moderate impact on the Dydrogesterone market, with a decline in new diagnoses and hospital visits. However, regular sales of already prescribed Dydrogesterone helped mitigate some of this decline[3].

Regulatory Hurdles

Changes in regulatory environments can pose challenges to the market. Strict regulations and approval processes can delay the introduction of new Dydrogesterone formulations[2].

Competition

The market is competitive, with several key players such as Pantarhei Bioscience, Abbott, Solvay, AbbVie, and Kolmar Korea. This competition can drive innovation but also presents challenges for market share and pricing strategies[2].

Financial Analysis

Revenue and Growth Rate

The global Dydrogesterone market is expected to grow from USD 942.5 million in 2024 to USD 1,813.41 million by 2031, with a CAGR of 9.80%. This significant growth indicates a robust financial trajectory for the market[1].

Regional Revenue Breakdown

  • North America: USD 377 million in 2024, growing at a CAGR of 8%[1].
  • Europe: USD 282.75 million in 2024, growing at a CAGR of 8.3%[1].
  • Asia Pacific: USD 216.78 million in 2024, growing at a CAGR of 11.8%[1].

Key Players and Market Share

Key players in the market include Pantarhei Bioscience, Abbott, Solvay, AbbVie, and Kolmar Korea. These companies are driving the market through their extensive research and development efforts, as well as their strong market presence[2].

Competitive Landscape

The Dydrogesterone market is characterized by a competitive landscape with several major players. These companies are engaged in continuous research and development to enhance the efficacy and safety of Dydrogesterone formulations. The competitive analysis includes factors such as product portfolio, financial position, growth strategies, and regional presence[2].

Customer Landscape and Decision Framework

Understanding the customer landscape is crucial for market growth. The report provides insights into customer preferences, target audience, and current tactics used by key players. Decision-making frameworks, such as PORTER and PESTEL analyses, help stakeholders understand the potential impact of micro-economic factors on the market[2].

Market Trends and Future Prospects

The Dydrogesterone market is expected to be influenced by several trends, including the integration of telehealth services, the emphasis on personalized medicine, and the ongoing research into the efficacy and safety of Dydrogesterone. These trends suggest a positive future outlook for the market, with significant growth potential over the forecast period[1].

Key Takeaways

  • The global Dydrogesterone market is projected to grow significantly, driven by increasing awareness of women's health and advancements in healthcare infrastructure.
  • North America dominates the market, but the Asia Pacific region is expected to grow at a higher CAGR.
  • Key drivers include supportive regulatory environments, ongoing research, and the integration of telehealth services.
  • The market faces challenges such as the impact of COVID-19 and regulatory hurdles.
  • Major players are driving innovation and market growth through extensive research and development.

FAQs

What is the current global market size of Dydrogesterone?

The global Dydrogesterone market size is estimated to be USD 942.5 million in 2024[1].

What is the projected CAGR of the Dydrogesterone market from 2024 to 2031?

The Dydrogesterone market is expected to grow at a CAGR of 9.80% from 2024 to 2031[1].

Which region dominates the Dydrogesterone market?

North America currently dominates the Dydrogesterone market, holding more than 40% of the global revenue[1].

What are the key drivers of the Dydrogesterone market?

Key drivers include increasing awareness of women's health, advancements in healthcare infrastructure, supportive regulatory environments, and ongoing research into the efficacy and safety of Dydrogesterone[1].

How has the COVID-19 pandemic affected the Dydrogesterone market?

The COVID-19 pandemic had a moderate impact on the market, with a decline in new diagnoses and hospital visits, but regular sales of already prescribed Dydrogesterone helped mitigate some of this decline[3].

Cited Sources

  1. Cognitive Market Research - Dydrogesterone Market Report 2024[1]
  2. OpenPR - Dydrogesterone Drug Market Analysis, Size, Current Scenario and Future Prospects[2]
  3. MarketStatsville - Dydrogesterone Drug Market Size Growth Analysis Segments and Forecast[3]
  4. 360iResearch - Dydrogesterone Market Size & Share 2025-2030[4]
  5. Cognitive Market Research - Dydrogesterone Tablet Market Report 2024 (Global Edition)[5]

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