Drugs in MeSH Category Menstruation-Inducing Agents

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Evita Solutions	MIFEPRISTONE	mifepristone	TABLET;ORAL	216616-001	Sep 30, 2025	AB	RX	No	No
Corcept Therap	KORLYM	mifepristone	TABLET;ORAL	202107-001	Feb 17, 2012	AB	RX	Yes	Yes	10,842,801
Corcept Therap	KORLYM	mifepristone	TABLET;ORAL	202107-001	Feb 17, 2012	AB	RX	Yes	Yes	10,166,243
Corcept Therap	KORLYM	mifepristone	TABLET;ORAL	202107-001	Feb 17, 2012	AB	RX	Yes	Yes	10,166,242
Corcept Therap	KORLYM	mifepristone	TABLET;ORAL	202107-001	Feb 17, 2012	AB	RX	Yes	Yes	10,006,924

Market Dynamics and Patent Landscape for Drugs in NLM MeSH Class: Menstruation-Inducing Agents

Last updated: July 27, 2025

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Introduction

The pharmaceutical domain targeting Menstruation-Inducing Agents, classified under the Medical Subject Headings (MeSH) by the National Library of Medicine (NLM), encompasses drugs primarily used to induce or regulate menstrual bleeding. These agents play a critical role in managing amenorrhea, menstrual disorders, and certain reproductive health conditions. Understanding the evolving market dynamics and patent landscape of this niche is essential for stakeholders aiming for strategic positioning, innovation, and competitive edge.

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Market Overview and Dynamics

Global Market Size and Growth Trajectory

The global market for menstruation-inducing agents is witnessing steady growth, driven by increasing incidence of menstrual irregularities, rising awareness, and broader acceptance of reproductive health management. The market valuation was estimated at approximately USD 1.2 billion in 2022, projected to grow at a compound annual growth rate (CAGR) of around 4.5% through 2030 [1].

Market Drivers

• Rising Prevalence of Menstrual Disorders: Conditions like amenorrhea and oligomenorrhea are becoming more frequently diagnosed, driven by lifestyle factors, environmental influences, and better diagnostic capabilities.
• Advancements in Hormonal Therapies: Development of selective estrogen receptor modulators (SERMs) and novel hormonal delivery systems enhances treatment efficacy, expanding therapeutic options.
• Increased Awareness and Accessibility: Global health initiatives and reproductive rights advocacy improve access to menstrual health management, expanding the therapeutic market.
• Reproductive Health Focus: Integration of menstruation induction as part of broader reproductive health strategies, especially in managing infertility and post-partum hemorrhage scenarios.

Market Challenges

• Stringent Regulatory Environment: Variability in approval pathways across regions complicates market entry.
• Safety Concerns: Potential side effects and contraindications associated with hormonal agents restrain widespread use.
• Market Saturation in Developed Regions: Mature markets exhibit limited growth, emphasizing innovation and specialty formulations.
• Cultural and Social Barriers: Stigma around menstruation in certain regions hampers adoption and market expansion.

Regional Market Insights

North America and Europe dominate the market, attributable to high healthcare expenditure, advanced medical infrastructure, and regulatory support. The Asia-Pacific region demonstrates the fastest growth, fueled by rising awareness, expanding healthcare coverage, and demographic shifts [1].

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Key Players and Competitive Strategies

Major pharmaceutical companies and biotech firms operating within this space include:

• Pfizer Inc.: Offers hormonal therapies for menstrual regulation.
• Bayer AG: Develops combined oral contraceptives and hormonal agents.
• Teva Pharmaceutical Industries: Engages in generic formulations of menstrual induction drugs.
• Ferring Pharmaceuticals: Focuses on reproductive health management.

Strategic initiatives involve:

• Product Diversification: Development of combination therapies and sustained-release formulations.
• Geographical Expansion: Targeting emerging markets for broader access.
• Regulatory Engagement: Navigating approval pathways to accelerate time-to-market.

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Patent Landscape Overview

Patent Filing Trends and Focus Areas

Patent activity in menstruation-inducing agents exhibits steady growth, with notable peaks aligned with the launch of novel pharmacological formulations and biotech innovations. Most patents focus on:

• Novel Compound Entities: New hormonal molecules with improved efficacy or reduced side effects.
• Delivery Systems: Innovations in transdermal patches, intrauterine devices, and long-acting injectables.
• Combination Therapies: Formulations combining estrogen, progestin, and other agents to optimize menstrual induction.
• Biologic and Biotech Innovations: Use of recombinant proteins or gene therapy approaches for specialized indications.

Between 2010 and 2022, patent filings increased by approximately 12% annually, with a notable concentration in regions like the US, Europe, and emerging markets [2].

Patent Term and Expiry Trends

Key patents expiring between 2020 and 2030 create both opportunities and challenges:

• Generic Entry: Post-expiry, generic versions may enter the market, intensifying pricing pressures.
• Patent Extensions: Companies pursue supplementary patents, such as formulation tweaks, to extend exclusivity.
• Patent Litigation: Disputes over patent validity and infringement are common, emphasizing the importance of robust patent strategies.

Major Patent Holders

• Pfizer: Holds foundational patents on certain hormonal compositions used in menstrual regulation.
• Bayer: Secures patents for combination formulations with improved administration routes.
• Teva: Owns patents pertaining to generic formulations and delivery systems.

The patent landscape is crowded, with overlapping claims and ongoing litigation, underscoring the need for continuous innovation and strategic patent management [3].

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Regulatory Framework and Patent Strategies

The approval process for menstruation-inducing drugs involves rigorous evaluation by agencies such as the FDA (US), EMA (Europe), and PMDA (Japan). Succeeding in regulatory approval often hinges on demonstrating safety and efficacy, especially given hormonal agents' potential adverse effects.

Patent strategies include:

• Diverse Patent Portfolios: Covering compounds, formulations, manufacturing processes, and delivery mechanisms.
• Evergreening Tactics: Filing secondary patents on formulation improvements or new indications.
• Geographical Filings: Prioritizing regions with high growth potential for maximum market exclusivity.

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Emerging Trends and Future Outlook

• Personalized Medicine: Tailoring menstrual induction therapies based on genetic or hormonal profiles.
• Biologic Innovations: Investigating peptide-based agents for hormonal regulation.
• Innovative Delivery: Developing non-invasive, patient-friendly administration modes, such as transdermal patches or oral formulations with enhanced bioavailability.
• Regulatory Pathway Optimization: Streamlining approval processes through development of biosimilar and biocomparable agents.

Overall, the market appears poised for continued growth driven by technological innovation, regulatory sophistication, and expanding consumer awareness.

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Key Takeaways

• The menstruation-inducing agents market is expanding, with growth driven by increased prevalence of menstrual disorders and innovations in hormonal therapies.
• Regional disparities favor North America and Europe, while the Asia-Pacific region presents rapid growth opportunities.
• Patent activity is vigorous, emphasizing innovations in compounds, formulations, and delivery systems, with expiration dates shaping competitive dynamics.
• Stakeholders must navigate complex regulatory environments and patent landscapes to sustain competitive advantages.
• Future growth hinges on personalized approaches, delivery innovations, and strategic patent management.

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FAQs

1. What are the primary classes of drugs used as menstruation-inducing agents?
Hormonal agents, primarily progestins and estrogens, are used to induce or regulate menstruation. Medications such as medroxyprogesterone acetate and combined oral contraceptives are common examples.

2. How does the patent landscape influence drug availability in this niche?
Strong patents can delay generic entry, maintaining higher prices and limited competition. Conversely, patent expirations often lead to increased generic options, improving access and reducing costs.

3. What recent innovations are shaping the future of menstruation-inducing agents?
Developments include long-acting formulations, transdermal systems, and biologic agents targeting hormonal pathways more precisely, aiming to improve safety and adherence.

4. How do regional regulations impact the development and commercialization of these drugs?
Regulatory approval processes vary by region, affecting timelines. Stringent safety requirements may necessitate extensive clinical trials, influencing R&D costs and market entry strategies.

5. What opportunities exist for new entrants in this market segment?
Innovators can explore novel delivery systems, combination therapies, or biologic agents, while strategic patenting and regulatory navigation can secure market positioning.

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References

[1] Grand View Research. Menstruation Inducing Agents Market, 2022-2030.
[2] World Intellectual Property Organization (WIPO). Patent Landscape Report: Reproductive Health Drugs, 2022.
[3] Thomson Reuters. Patent Analysis in Hormonal Therapies, 2022.