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-five 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:	116
Clinical Trials:	18
Patent Applications:	3,540
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
Clinique Ovo	Phase 2
The University of Hong Kong	Phase 3
Meir Medical Center	N/A

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		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
Canada	2568823	COMPRIMES DE PROGESTERONE A ADMINISTRATION VAGINALE ET METHODE DE PREPARATION (VAGINALLY ADMINISTRABLE PROGESTERONE-CONTAINING TABLETS AND METHOD FOR PREPARING SAME)
Israel	127129	METHOD FOR PREPARATION OF PROGESTERONE TABLETS FOR VAGINAL DELIVERY AND TABLETS SO PREPARED
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)

Supplementary Protection Certificates for ENDOMETRIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

ENDOMETRIN Market dynamics and financial trajectory Experimental

Market Dynamics and Financial Trajectory for Endometriosis Treatments: A Focus on Emerging Therapies

Introduction to Endometriosis

Endometriosis is a chronic and often debilitating gynecological disorder affecting millions of women worldwide. The market for endometriosis treatments is evolving rapidly, driven by advances in therapeutic options, increasing prevalence, and growing awareness.

Market Size and Growth

The global endometriosis treatment market is projected to experience significant growth. By 2030, the market is expected to surpass $4 billion, with a compound annual growth rate (CAGR) that indicates a robust expansion[3][4].

Key Market Drivers

Several factors are driving the growth of the endometriosis treatment market:

Increasing Prevalence

The total prevalent cases of endometriosis in the US alone were approximately 9,465,000 in 2022 and are projected to increase by 2034[1].

Technological Advancements

Advances in molecular diagnostics and non-invasive treatments are enhancing the therapeutic landscape. Innovators are accelerating the launch of clinical and scientific therapeutic agents, which will drive market growth[3].

Rising Awareness

Growing awareness about gynecological disorders among women is a significant driver. Educational campaigns and advocacy efforts are contributing to increased diagnosis and treatment rates[3].

Government Expenditure

Increasing government expenditure in healthcare, particularly in regions like Asia Pacific, is supporting market growth[3].

Key Market Restraints

Despite the growth, there are several restraints to consider:

Post-Therapy Complications

Side effects such as leg cramps, indigestion, and bloating associated with current therapies can deter some patients from seeking treatment[3].

Economic Factors

High costs associated with advanced treatments and the economic burden on patients can limit market expansion[4].

Emerging Therapies

Several emerging therapies are set to transform the endometriosis treatment market:

Linzagolix

Developed by ObsEva SA, linzagolix is an oral GnRH antagonist that has shown positive outcomes in Phase 3 trials for treating moderate to severe endometriosis-associated pain. This drug has significant market potential, especially with strategic licensing deals aimed at global commercialization[1].

Elagolix + Estradiol/Norethindrone Acetate

This combination therapy by AbbVie and Neurocrine Biosciences is another promising treatment. It combines a GnRH antagonist with hormonal additives to manage symptoms effectively[1].

Ovarest and HMI-115

Other notable therapies include Ovarest by Enteris BioPharma and HMI-115 by Hope Medicine, which are in various stages of development and are expected to contribute to the market growth[1].

Financial Trajectory

The financial performance of companies involved in the endometriosis treatment market is indicative of the market's overall health:

Revenue Projections

The US endometriosis market size was estimated to be around $1,200 million in 2022 and is projected to increase by 2034. Global revenues are expected to reach nearly $5 billion by 2032[1][4].

Segment Performance

Companies like Endo International plc have reported mixed financial results, with branded pharmaceuticals showing growth while generic and sterile injectables have seen declines. However, the overall trend suggests a stable to growing market for branded and specialty products[2][5].

Market Dynamics: Drivers and Barriers

Market Drivers

• Rapid Investments: Key stakeholders are investing heavily in research and development, driving innovation and market growth.
• Technological Advancements: Advances in diagnostics and treatments are improving patient outcomes and attracting more patients to seek treatment.
• Government Support: Increased government expenditure on healthcare is facilitating better access to treatments[3].

Market Barriers

• Side Effects: Post-therapy complications can deter patients from opting for certain treatments.
• Economic Constraints: High treatment costs and the economic burden on patients can limit market expansion.
• Regulatory Hurdles: Stringent regulatory requirements can slow down the approval and launch of new therapies[3].

Distribution Channels

The distribution of endometriosis treatments is primarily through:

Hospital Pharmacies

Hospital pharmacies capture a significant value proportion in the endometriosis market due to the need for specialized care and monitoring[3].

Retail Pharmacies and Drugstores

These channels are also important, especially for follow-up treatments and maintenance therapies.

e-Commerce

The rise of e-commerce is providing greater accessibility to patients, although it remains a smaller segment compared to traditional channels[4].

Regional Market Analysis

North America and Europe

These regions collectively capture a leading revenue share in the endometriosis treatment market due to high awareness, advanced healthcare infrastructure, and significant investment in research and development[3].

Asia Pacific

Growing government expenditure and increasing awareness are driving market growth in this region, making it a promising area for future expansion[3].

Key Takeaways

• The endometriosis treatment market is expected to grow significantly, driven by technological advancements and increasing prevalence.
• Emerging therapies like linzagolix and Elagolix + estradiol/norethindrone acetate are set to transform the treatment landscape.
• Hospital pharmacies remain the leading distribution channel, with North America and Europe dominating the market.
• Despite growth drivers, the market faces restraints such as post-therapy complications and economic constraints.

FAQs

What is the projected market size for endometriosis treatments by 2032?

The global endometriosis treatment market is projected to reach approximately $4.99 billion by 2032[4].

Which regions are expected to dominate the endometriosis treatment market?

North America and Europe are expected to capture the leading revenue share in the endometriosis treatment market through 2029[3].

What are some of the emerging therapies in the endometriosis treatment market?

Emerging therapies include linzagolix, Elagolix + estradiol/norethindrone acetate, Ovarest, and HMI-115[1].

What are the key drivers of the endometriosis treatment market?

Key drivers include rapid investments by stakeholders, technological advancements, rising awareness, and growing government expenditure[3].

What are some of the restraints facing the endometriosis treatment market?

Restraints include post-therapy complications, economic constraints, and regulatory hurdles[3].

Sources

1. DelveInsight: "Endometriosis Market Analysis 2034: Epidemiological Insights, Pipeline Therapies, Recent Drug Approvals by DelveInsight"[1]
2. PR Newswire: "Endo Reports Third-Quarter 2024 Financial Results and Reaffirms 2024 Financial Expectations"[2]
3. GlobeNewswire: "Demand for Endometriosis Treatment to Account for over US$ 4 Bn by 2030"[3]
4. Market Research Future: "Endometriosis Treatment Market Size, Growth, Trends 2032"[4]
5. Endo International plc: "Endo Provides Select First-Quarter 2024 Financial Results for Endo International plc"[5]