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-nine 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:	2
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	7,393,543
Ferring	ENDOMETRIN	progesterone	INSERT;VAGINAL	022057-001	Jun 21, 2007	7,300,664
Ferring	ENDOMETRIN	progesterone	INSERT;VAGINAL	022057-001	Jun 21, 2007	7,320,800

International Patents for ENDOMETRIN

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

Country	Patent Number	Title	Estimated Expiration
Japan	2002529494
Taiwan	I239249
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
European Patent Office	2386291
Japan	2011026335	PROGESTERONE-CONTAINING TABLET FOR TRANSVAGINAL ADMINISTRATION, AND PREPARATION METHOD THEREOF
Spain	2390959

Supplementary Protection Certificates for ENDOMETRIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	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
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	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: February 10, 2026

Overview
Endometrin (progesterone vaginal insert) is a pharmaceutical used primarily for luteal phase support in assisted reproductive technology (ART) cycles, such as in vitro fertilization (IVF). It is manufactured by Ferring Pharmaceuticals and approved by the U.S. Food and Drug Administration (FDA). The drug’s market hinges on fertility treatments, regulatory approvals, and emerging competition from biosimilars and alternative therapies.

Market Size and Growth Drivers
The global fertility treatments market was valued at $22.2 billion in 2022, with an expected compound annual growth rate (CAGR) of approximately 8% from 2023 to 2030.[1] Endometrin contributes significantly within the subset of drugs used for luteal phase support, which is projected to grow alongside rising infertility rates and advancements in ART.

Key market drivers:

• Increasing infertility prevalence due to environmental, lifestyle, and age-related factors offsets the stagnation in fertility treatment adoption.
• Rising awareness and acceptance of ART procedures expand the patient base for Endometrin.
• Improving regulatory environment in key markets (U.S., Europe, Asia) encourages product uptake.

Regulatory and Patent Landscape
The regulatory pathway for Endometrin has remained stable post-approval, with ongoing supplemental indications under review. Patent expiry timelines suggest generic competition could emerge around 2028, impacting pricing strategies. Ferring has secured market exclusivity through data protection until at least 2027, giving a window to establish market share before biosimilars enter.

Distribution Channels and Market Penetration
Endometrin predominantly sells via hospital pharmacies, fertility clinics, and specialty distributors. Market penetration varies geographically:

• North America: Dominates due to high ART adoption, with a market share estimated at 45% within the luteal support segment.
• Europe: Represents roughly 35%, with strong birthrate recovery programs post-pandemic.
• Asia-Pacific: Rapid growth driven by increasing healthcare infrastructure and fertility awareness, accounting for 15%.

Competitive Landscape
Endometrin faces competition from:

• Vaginal progesterone gels and capsules from companies like Merck (e.g., Crinone), with similar efficacy.
• Competing drugs like Prometrium (oral progesterone) that have different administration profiles.
• Emerging biosimilars entering markets from generic manufacturers.

Pricing strategies vary, with Endometrin retail prices averaging $250–$350 per treatment cycle in the U.S., depending on dosage and length of therapy. Competition and patent cliffs could pressure prices in the coming years.

Financial Trajectory
Historical revenues for Endometrin have shown steady growth, driven by increased ART procedures. In 2022, sales approximated $600 million globally.[2] Projections suggest:

• Compound annual sales growth of 6–8% over the next five years.
• Revenue acceleration expected in Asia-Pacific markets, with a projected CAGR of 10% from 2024 to 2028.
• Near-term margins remain healthy at approximately 50%, declining slightly with generic competition expected post-2028.

Ferring’s strategic focus includes expanding indications (e.g., progesterone in other reproductive health areas) and optimizing distribution networks to sustain growth. R&D investments remain modest, centered on formulation improvements and administration routes.

Recent Market Shifts and Trends

• Shift toward oral and injectable progesterone options offers clinical convenience but may reduce demand for vaginal inserts like Endometrin.
• Advances in personalized medicine and genetic screening influence ART success rates, impacting drug demand.
• COVID-19 pandemic initially suppressed ART procedures but recovery is underway, propelling growth.

Forecast Summary	Year	Estimated Global Revenue	Key Drivers
2023	$620 million	Increased ART cases, market penetration
2024	$660 million	New geographic entries, regulatory approvals
2025	$700 million	Expanded indications, competitive stabilization
2026	$750 million	Biosimilar threat, pricing adjustments
2028	$800 million	Peak growth, approaching patent expiry

Key Market Risks

• Accelerated patent expiration leading to biosimilar erosion.
• Changes in regulatory policies or reimbursement landscape.
• Competition from oral or injectable alternatives perceived as more convenient.

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Key Takeaways

• Endometrin’s market is expanding due to rising ART procedures globally.
• Revenue growth is driven by geographic expansion, but should slow after patent expiry.
• Competition and biosimilar threats are critical factors influencing future pricing and margins.
• Strategic focus on indications and distribution expansion influences long-term financial trajectory.
• Monitoring regulatory developments and biosimilar entrants remains essential for accurate forecasting.

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FAQs

1. What is the primary use of Endometrin?
It provides luteal phase support in fertility treatments like IVF.

2. How large is the current market for Endometrin?
Global sales are approximately $600 million as of 2022, with steady growth expected.

3. When are biosimilar competitors likely to impact Endometrin’s market?
Biosimilars may enter around 2028, coinciding with patent expiration.

4. Which regions are the main markets for Endometrin?
North America, Europe, and Asia-Pacific dominate, with Asia-Pacific growing fastest.

5. What factors could threaten Endometrin’s market share?
Patent expiry, competitive pricing for biosimilars, and alternative progesterone formulations.

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References
[1] Research, Markets. "Fertility Treatments Market Forecast," 2023.
[2] Ferring Pharmaceuticals annual reports, 2022.