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-six 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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	106
Clinical Trials:	19
Patent Applications:	4,099
Drug Prices:	Drug price information for ENDOMETRIN
What excipients (inactive ingredients) are in ENDOMETRIN?	ENDOMETRIN excipients list
DailyMed Link:	ENDOMETRIN at DailyMed

See drug prices for ENDOMETRIN

See drug sales revenues for ENDOMETRIN

Recent Clinical Trials for ENDOMETRIN

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

Sponsor	Phase
Shaare Zedek Medical Center	EARLY_PHASE1
Clinique Ovo	Phase 2
The University of Hong Kong	Phase 3

See all ENDOMETRIN clinical trials

Pharmacology for ENDOMETRIN

Drug Class

Progesterone

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

Expired US Patents for ENDOMETRIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ferring	ENDOMETRIN	progesterone	INSERT;VAGINAL	022057-001	Jun 21, 2007
Ferring	ENDOMETRIN	progesterone	INSERT;VAGINAL	022057-001	Jun 21, 2007
Ferring	ENDOMETRIN	progesterone	INSERT;VAGINAL	022057-001	Jun 21, 2007

International Patents for ENDOMETRIN

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

Country	Patent Number	Title	Estimated Expiration
Denmark	1131052
Japan	2002529494
Australia	1176200
Taiwan	I239249
Japan	2011026335	PROGESTERONE-CONTAINING TABLET FOR TRANSVAGINAL ADMINISTRATION, AND PREPARATION METHOD THEREOF

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
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
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	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

Market Dynamics and Financial Trajectory for ENDOMETRIN

Last updated: July 28, 2025

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Introduction

ENDOMETRIN (progesterone vaginal inserts) is a pharmaceutical product primarily used for reproductive health indications, including luteal phase support in assisted reproductive techniques (ART) such as in-vitro fertilization (IVF) and treatment of certain cases of hormone deficiency. The drug’s market dynamics are shaped by evolving clinical practices, regulatory landscapes, and competitive forces. Its financial trajectory depends on clinical acceptance, regulatory approvals, patent status, and competitive positioning within the hormonal and fertility treatment markets.

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Market Landscape and Demand Drivers

Reproductive Medicine and Growing Fertility Treatments

The global infertility market is expanding, driven by demographic shifts, delayed childbearing, and increased awareness of fertility options. The rising prevalence of conditions such as polycystic ovary syndrome (PCOS), endometriosis, and age-related decline in fertility fuels demand for ART. According to the International Committee for Monitoring Assisted Reproductive Technologies (ICMART), the number of ART cycles increased worldwide by approximately 5-10% annually pre-pandemic, with recovery post-COVID-19 bolstering demand (source [1]).

Clinical Efficacy and Physician Acceptance

ENDOMETRIN’s role as a luteal phase support agent relies on its proven efficacy in synchronizing endometrial receptivity with embryonic development. Clinical guidelines from societies like the American Society for Reproductive Medicine (ASRM) endorse progesterone support in ART cycles, supporting consistent prescribing patterns.

Regulatory Approvals and Geographic Markets

ENDOMETRIN holds regulatory approval primarily in the United States, European Union, and select Asian markets. Expansion into emerging markets like Latin America and the Middle East presents growth opportunities, contingent on regulatory approval and local acceptance of fertility treatments.

Competition and Market Share

The fertility support segment is populated with alternative formulations, including intramuscular progesterone and other vaginal preparations. Notably, the competitive landscape includes products like Crinone (vaginal gel), Cyclogest (progesterone suppositories), and compounded formulations. ENDOMETRIN’s market share depends on factors such as delivery efficacy, patient tolerability, positioning by key pharmaceutical companies, and pricing strategies.

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Market Challenges and Competitive Dynamics

Pricing Pressures and Reimbursement Policies

In mature markets, reimbursement policies significantly influence prescribing behaviors. Payer negotiations, formulary inclusions, and competitive pricing impact profit margins. As healthcare systems aim for cost containment, branded products like ENDOMETRIN face competition from generic equivalents in markets where patents have expired or are nearing expiration.

Patent Life and Generic Competition

ENDOMETRIN’s patent expiry timelines critically determine its financial trajectory. Once patent protection lapses, generic equivalents can erode market share and pricing power, compelling manufacturers to innovate or seek new indications.

Regulatory and Safety Considerations

Strict regulatory requirements ensure product safety but can delay market expansion and new indications. Additionally, post-marketing safety data impacts clinical confidence and adoption rates.

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Financial Trajectory

Revenue Streams and Growth Potential

The key revenue channel for ENDOMETRIN is wholesale and retail sales within fertility clinics and hospitals. The global fertility drugs market was valued at approximately USD 5.8 billion in 2020 and is projected to grow at a CAGR of about 8% through 2028, approaching USD 13 billion (source [2]). Within this, hormonal support products like ENDOMETRIN represent a proportional segment, with higher margins driven by brand recognition and clinical preference.

Impact of Market Penetration and New Indications

Expanding into additional indications, such as hormone replacement therapy (HRT) for menopause or counteracting luteal deficiencies in other contexts, could diversify revenue streams. However, these routes require demonstrating safety and efficacy through clinical trials, involving significant investment and regulatory navigation.

Strategic Partnerships and M&A

Pharmaceutical companies often pursue licensing agreements or acquisition of smaller biotech firms to strengthen their portfolio and extend product lifecycle. These strategies may include developing new formulations, delivery methods, or combination therapies involving ENDOMETRIN.

Forecasting the Financial Outlook

Given current patent statuses and market penetration rates, the forecast for ENDOMETRIN indicates stable revenues in mature markets, with potential growth in emerging regions. However, the imminent threat of generic competition may pressure margins unless the product retains differentiation through clinical advantages or new formulations.

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Regulatory and Innovation Trends

Product Differentiation and Delivery Innovations

Innovation in delivery mechanisms, such as sustained-release vaginal inserts or combinations with other hormones, offers avenues to extend market relevance and command premium pricing. Regulatory support for such innovations could revitalize the product’s financial trajectory.

Regulatory Landscape Evolution

Regulatory agencies’ evolving standards, especially around biosimilars and generics, influence market competitiveness. Ongoing compliance costs and the necessity of rigorous post-marketing surveillance may affect margins.

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Market Opportunities and Strategic Recommendations

Potential for Geographic Expansion

Targeting emerging markets with rising fertility treatment adoption offers substantial upside. Facilitating access through partnerships and local manufacturing can reduce costs and improve market share.

Developing Adjunct Indications

Research into additional fertility-related or hormonal balance indications could unlock new revenue streams. Securing approval for such uses depends on robust clinical data demonstrating safety and efficacy.

Innovation Focus

Investing in proprietary delivery systems, such as nanoparticle-based or sustained-release vaginal inserts, can differentiate ENDOMETRIN and extend patent protections, preserving profitability.

Collaborations and Licensing

Forming strategic alliances with regional pharmaceutical firms can accelerate market entry and mitigate regulatory hurdles, expanding global footprint and revenue.

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Key Takeaways

• The fertility drugs market, including ENDOMETRIN, is poised for steady growth driven by demographic and clinical trends, though facing impending generic competition.
• Market shareability depends on clinical efficacy, formulary positioning, and innovation in delivery mechanisms.
• Regulatory landscapes and reimbursement policies significantly influence revenue sustainability.
• Expanding into emerging markets and developing novel formulations can buffer against patent expiration impacts.
• Strategic collaborations and investment in innovation are crucial to prolonging product lifecycle and boosting financial trajectory.

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FAQs

1. What is the primary indication for ENDOMETRIN?
   ENDOMETRIN is primarily indicated for luteal phase support in assisted reproductive techniques (ART), such as IVF, to enhance implantation success.

2. How does ENDOMETRIN compare to other progesterone formulations?
   ENDOMETRIN’s vaginal insert delivery provides localized hormone levels with reportedly fewer systemic side effects, offering convenience and potentially better tolerability compared to intramuscular injections or suppositories.

3. What are the main challenges facing ENDOMETRIN’s market growth?
   Challenges include patent expiry leading to generic competition, pricing pressures from healthcare providers, and the need for continual innovation to maintain differentiation.

4. Are there opportunities for ENDOMETRIN outside reproductive health?
   Potentially yes. Progesterone formulations may find applications in hormone replacement therapy (HRT) or endometrial protection in certain medical conditions, pending clinical research and regulatory approval.

5. What strategies can pharmaceutical companies adopt to maximize ENDOMETRIN’s financial gains?
   Companies should focus on geographic expansion, innovation in delivery systems, diversification into new indications, and strategic alliances to sustain revenue streams and extend product lifecycle.

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References

[1] ICMART World Report on Assisted Reproductive Technology, 2019.
[2] MarketsandMarkets, “Fertility Drugs Market by Product (Follitropin, Urofollitropin, hMG, hCG, GnRH), Application, and Region — Global Forecast to 2028,” 2021.