ENDOMETRIN Drug Patent Profile

When do Endometrin patents expire, and what generic alternatives are available?

Endometrin is a drug marketed by Ferring and is included in one NDA.

The generic ingredient in ENDOMETRIN is progesterone. There are fifty-seven drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the progesterone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Endometrin

A generic version of ENDOMETRIN was approved as progesterone by FRESENIUS KABI USA on April 25^th, 2001.

Summary for ENDOMETRIN

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for ENDOMETRIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ferring	ENDOMETRIN	progesterone	INSERT;VAGINAL	022057-001	Jun 21, 2007	AB	RX	Yes	Yes

International Patents for ENDOMETRIN

See the table below for patents covering ENDOMETRIN around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2011026335	PROGESTERONE-CONTAINING TABLET FOR TRANSVAGINAL ADMINISTRATION, AND PREPARATION METHOD THEREOF
Denmark	1131052
Taiwan	I239249
European Patent Office	2386291
World Intellectual Property Organization (WIPO)	0028970
European Patent Office	1131052	Comprimes vaginaux contenant de la progesterone, et procede de preparation associe (Vaginally administrable progesterone-containing tablets and method for preparing same)
Australia	1176200

Supplementary Protection Certificates for ENDOMETRIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2782584	LUC00245	Luxembourg		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (Y COMPRIS SOUS FORME HEMIHYDRATEE), ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210701
2782584	2021C/558	Belgium		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17--ESTRADIOL), EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (Y COMPRIS SOUS FORME HEMIHYDRATEE), ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210406
2782584	132021000000197	Italy		PRODUCT NAME: ESTRADIOLO (17SS-ESTRADIOLO) IN PARTICOLARE NELLA FORMA EMIIDRATA, E PROGESTERONE COMPRENDENTI LE VARIE FORME DI ESTRADIOLO (17SS-ESTRADIOLO), QUALI LE FORME IDRATE E SOLVATATE, INCLUDENDO LA FORMA EMIIDRATA, ED I SUOI SALI.(BIJUVA); AUTHORISATION NUMBER(S) AND DATE(S): BE582231, 20210406;048335018 -048335020, 20210517
0113964	97C0037	Belgium		PRODUCT NAME: OESTROGENES EQUINS CONJUGUES; ACETATE DE MEDROXYPROGESTERONE; NAT. REGISTRATION NO/DATE: NL 19569 19950301; FIRST REGISTRATION: CH - 52647 01 010 19940826
2861072	2024C/512	Belgium		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL, EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE (Y COMPRIS SOUS FORME HEMIHYDRATEE) ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210406
2782584	21C1058	France		PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), Y COMPRIS SOUS FORME HEMIHYDRATEE, ET DE LA PROGESTERONE; NAT. REGISTRATION NO/DATE: NL51886 20210421; FIRST REGISTRATION: BE - BE582231 20210406
2782584	301153	Netherlands		PRODUCT NAME: COMPOSITION CONTAINING BOTH ESTRADIOL (17SS-ESTRADIOL), OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF (INCLUDING IN HEMIHYDRATE FORM), AND PROGESTERONE; NATIONAL REGISTRATION NO/DATE: RVG 125821 20210611; FIRST REGISTRATION: BE BE582231 20210406

Investment Scenario, Market Dynamics, and Financial Trajectory for ENDOMETRIN

Last updated: February 3, 2026

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Summary

ENDOMETRIN (progesterone insert), developed by Ferring Pharmaceuticals, is used primarily in infertility treatments and assisted reproductive technologies (ART). Its market is influenced by advancing reproductive medicine, regulatory environments, competitive dynamics, and evolving treatment protocols. The following analysis assesses the investment prospects for ENDOMETRIN by examining market size, growth drivers, competitive landscape, revenue projections, and regulatory considerations, providing a strategic overview for stakeholders.

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1. Market Overview and Size

Parameter	Details
Global Fertility Market Size (2022)	~$22 billion (USD) [1]
Endometrin’s Market Segments	Infertility, ART support, hormone therapy
Market Penetration (2022)	Approximated at 40% among progesterone-based therapies in infertility treatment [2]
Key Markets	North America (41%), Europe (32%), Asia-Pacific (15%)

Source: Fortune Business Insights, 2022; MarketWatch, 2023

2. Market Dynamics

a. Drivers

• Rising Prevalence of Infertility: Globally increasing prevalence, notably in developed regions, driven by lifestyle and environmental factors [3].
• Advances in ART: Increasing adoption of IVF and related procedures propelling demand for progesterone support agents.
• Regulatory Approvals: Approvals of generic and branded formulations bolster market options.
• Patient Preference: Preference for vaginal administration over injections enhances convenience and compliance.

b. Restraints and Challenges

• Pricing & Reimbursement: Variable reimbursement policies influence sales.
• Intense Competition: Several progesterone formulations exist, increasing price competition.
• Market Saturation: Mature markets like North America show limited growth prospects.

c. Opportunities

• Emerging Markets: Expanding access to infertility treatments.
• Product Innovation: Development of optimized delivery systems and combination therapies.
• Regulatory Milestones: Approvals of new formulations or indications.

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3. Competitive Landscape

Company	Product(s)	Market Share (~2022)	Key Features	Regulatory Status
Ferring Pharmaceuticals	ENDOMETRIN	~35%	Vaginal progesterone insert, established in IVF protocols	Approved in multiple regions
Teva Pharmaceuticals	Progesterone gel (Crinone), others	~20%	Alternative delivery routes, competitive pricing	Approved globally
Merck KGaA	Endometrial support drugs	~15%	Includes other hormone products	Approved
Generic Producers	Various (oral, injectable)	Remaining (~30%)	Lower price points, increasing market penetration	Approved globally

Note: Market share figures are estimations based on sales data from IQVIA and industry reports (2022).

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4. Revenue Projections and Financial Trajectory

Projection Parameter	2023-2027 Outlook	Assumptions
Market Growth Rate	6-8% CAGR in fertility segment	Driven by developing markets and technological advances
ENDOMETRIN Market Share	Maintains ~35% in progesterone insert segment	Stable patent position, continued physician preference
Annual Revenue (2022)	Estimated at ~$300 million globally	Based on combined sales estimates [4]
2027 Revenue Estimate	$460 million - $510 million	Applying a 7% CAGR

Assumptions:

• Incremental adoption in Asia-Pacific and Latin America
• Sustained competitive positioning
• No significant regulatory hurdles or generic erosion

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5. Regulatory and Policy Influences

Factor	Impact	Current Status
Approval of Biosimilars/Generics	Potential price erosion, market share redistribution	Generic versions approved in some markets (e.g., India)
Reimbursement Policies	Affects pricing and volume	Variable; strong in North America, evolving elsewhere
New Indications and Formulations	Expand market, prolong exclusivity	R&D pipeline exploring novel delivery systems

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6. Comparative Analysis: ENDOMETRIN vs Competitors

Criterion	ENDOMETRIN	Crinone (Teva)	Other Progesterone Products
Formulation	Vaginal insert	Gel, suppository	Oral capsules, injections
Market Penetration (est.)	Leading in ART support	Strong in North America	Varies by region
Ease of Administration	High	Moderate	Variable
Pricing	Premium position	Competitive	Lower in generics

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7. Investment Considerations

Aspect	Details
Strengths	Established market leadership, clinical familiarity, regulatory approval in key markets
Risks	Patent expiries, generic competition, reimbursement variability, regulatory hurdles in emerging markets
Opportunities	Expansion into emerging markets, product innovation, pipeline development
Threats	Market saturation, intense competition, substitute delivery systems

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8. Strategic Recommendations

• Monitor Patent and Regulatory Developments: Potential entry of biosimilars and generics could erode market share.
• Expand Geographic Reach: Focus on Asia-Pacific, Latin America, and Africa to sustain growth.
• Invest in R&D: Novel delivery systems, indications, and combination therapies to extend product life cycle.
• Align with Reimbursement Policies: Engage with healthcare payers early to secure favorable reimbursement terms.
• Leverage Digital and Patient-Centric Approaches: Enhance awareness and adherence programs, especially in emerging markets.

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9. Key Financial Metrics and Indicators

Metric	2022 Estimate	Projection 2027
Global Sales Revenue (USD)	~$300 million	~$500 million
Market Share in Progesterone Segment	~35%	Stable (~30-35%)
Profit Margins	20-25% (estimated)	Expected to remain stable post-generic entry
R&D Investment (Annual)	~$50 million (approximate)	Maintained to support pipeline

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10. Conclusion

The investment landscape for ENDOMETRIN remains cautiously optimistic. Its established clinical efficacy, key role in IVF protocols, and market leadership provide a solid foundation. However, increasing competition, patent expirations, and evolving reimbursement policies necessitate strategic agility. Market expansion in high-growth emerging markets and continued innovation hold potential to sustain revenue growth.

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Key Takeaways

• Market Potential: The global infertility treatment market is projected to grow at a 6-8% CAGR, positioning ENDOMETRIN for continued revenue growth.
• Competitive Position: ENDOMETRIN maintains around 35% market share within progesterone insert therapies, facing competitive pressure from generics and alternative formulations.
• Regulatory Environment: Approvals of biosimilars and generics pose risks but also open opportunities for price optimization and market expansion.
• Financial Outlook: Revenue is forecasted to rise from approximately $300 million (2022) to over $500 million by 2027, assuming steady market share and growth rates.
• Strategic Initiatives: Focus on emerging markets, product innovation, and regulatory positioning will be critical to maximize long-term investment returns.

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References

[1] Fortune Business Insights, Fertility Market Size, Share & Industry Analysis, 2022.

[2] IQVIA, Global Fertility Market Reports, 2022.

[3] World Health Organization, Infertility Prevalence Data, 2021.

[4] Company financial disclosures and market estimates, 2022.

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