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INTRAROSA Drug Patent Profile

Which patents cover Intrarosa, and what generic alternatives are available?

Intrarosa is a drug marketed by Millicent and is included in one NDA. There are three patents protecting this drug.

This drug has fifty-eight patent family members in thirty-one countries.

The generic ingredient in INTRAROSA is prasterone. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the prasterone profile page.

DrugPatentWatch^® Generic Entry Outlook for Intrarosa

Intrarosa was eligible for patent challenges on November 16, 2020.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 7, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for INTRAROSA

International Patents:	58
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	8
Patent Applications:	3,994
Drug Prices:	Drug price information for INTRAROSA
What excipients (inactive ingredients) are in INTRAROSA?	INTRAROSA excipients list
DailyMed Link:	INTRAROSA at DailyMed

See drug prices for INTRAROSA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for INTRAROSA

Constraining patent/regulatory exclusivity:

8,629,129

NDA:

208470

Dosage:

INSERT;VAGINAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for INTRAROSA

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

Sponsor	Phase
Lee's Pharmaceutical Limited	Phase 3
University of Arkansas	Phase 2
AMAG Pharmaceuticals, Inc.	Phase 2

See all INTRAROSA clinical trials

US Patents and Regulatory Information for INTRAROSA

INTRAROSA is protected by three US patents.

This potential generic entry date is based on patent 8,629,129.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Millicent	INTRAROSA	prasterone	INSERT;VAGINAL	208470-001	Nov 16, 2016		RX	Yes	Yes	8,957,054
Millicent	INTRAROSA	prasterone	INSERT;VAGINAL	208470-001	Nov 16, 2016		RX	Yes	Yes	8,268,806		Y
Millicent	INTRAROSA	prasterone	INSERT;VAGINAL	208470-001	Nov 16, 2016		RX	Yes	Yes	8,629,129		Y

EU/EMA Drug Approvals for INTRAROSA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Endoceutics S.A.	Intrarosa	prasterone	EMEA/H/C/004138 Intrarosa is indicated for the treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms.,	Authorised	no	no	no	2018-01-08

International Patents for INTRAROSA

When does loss-of-exclusivity occur for INTRAROSA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Mexico

Morocco

New Zealand

Norway

Peru

Philippines

Portugal

Saudi Arabia

Singapore

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering INTRAROSA around the world.

Country	Patent Number	Title	Estimated Expiration
China	109893526	治疗绝经期的DEHA组合物 (DHEA compositions for treating menopause)
South Africa	201000874	Dhea compositions for treating menopause
China	105412121	DHEA compositions for treating menopause
Australia	2008286651	DHEA compositions for treating menopause
Eurasian Patent Organization	201200369	ПРИМЕНЕНИЕ ПРЕДШЕСТВЕННИКОВ ПОЛОВЫХ СТЕРОИДНЫХ ГОРМОНОВ В КОМБИНАЦИИ С СЕЛЕКТИВНЫМ МОДУЛЯТОРОМ ЭСТРОГЕНОВЫХ РЕЦЕПТОРОВ ДЛЯ ЛЕЧЕНИЯ ЗАБОЛЕВАНИЙ И СОСТОЯНИЙ У ПОСТМЕНОПАУЗНЫХ ЖЕНЩИН
China	102861335	DHEA compositions for treating menopause
Mexico	2010001627	COMPOSICIONES DE DHEA PARA EL TRATAMIENTO DE LA MENOPAUSIA. (DHEA COMPOSITIONS FOR TREATING MENOPAUSE.)

Supplementary Protection Certificates for INTRAROSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2185157	C02185157/01	Switzerland		PRODUCT NAME: PRASTERON; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67323 19.05.2020

INTRAROSA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Intrarosa

Introduction

Intrarosa, a prescription drug developed by Endoceutics Inc., has been a significant player in the treatment of moderate to severe dyspareunia, a common symptom of vulvar and vaginal atrophy (VVA) due to menopause. Here, we delve into the market dynamics and financial trajectory of Intrarosa, highlighting its unique positioning, acquisition history, and future prospects.

Unique Positioning in the Market

Intrarosa stands out from other hormone replacement therapies due to its unique formulation. It is the only prescription drug that provides both estrogen and androgen for the treatment of dyspareunia, without containing conventional pharmacological estrogen. This differentiation is crucial as it does not carry a boxed safety warning on its label, a significant advantage over other hormone replacement therapies[1][4].

Acquisition History

The ownership and commercial rights of Intrarosa have undergone significant changes, reflecting its value and market potential.

Millicent Pharma Acquisition

In 2020, Millicent Pharma Limited acquired the U.S. commercial rights to Intrarosa from AMAG Pharmaceuticals, Inc. for up to $125 million, including an upfront payment of $20 million and contingent, sales-based milestone payments of up to $105 million. This acquisition was part of Millicent Pharma's strategy to build a diversified women’s health business[2].

Cosette Pharmaceuticals Acquisition

In June 2023, Cosette Pharmaceuticals, Inc. acquired the global rights to Intrarosa from Endoceutics, Inc. This transaction included 108 issued and pending patents worldwide, with the latest expiring in 2033. Cosette plans to leverage its commercial and manufacturing capabilities to expand Intrarosa's global footprint, particularly with existing distribution partners and upcoming launches in Asian markets in 2025[1].

Market Reach and Distribution

Intrarosa is currently available in major markets including the U.S., UK, EU, Canada, and Israel, through various local partners such as Theramex, Tecnimede, Avia, Lupin, Dexcel, Labatec, Lacer, Lee’s Pharma, and Valenta. This widespread distribution underscores its market acceptance and demand[1].

Financial Trajectory

The financial trajectory of Intrarosa is marked by significant investment and potential for growth.

Transaction Values

The acquisition by Millicent Pharma in 2020 was valued at up to $125 million, indicating the drug's commercial potential. The subsequent acquisition by Cosette Pharmaceuticals, though the exact price was not disclosed, highlights the continued interest and value placed on Intrarosa[1][2].

Market Potential

Given that an estimated 64 million post-menopausal women suffer from VVA, and between 44% and 78% of these women experience dyspareunia, the market potential for Intrarosa is substantial. In the U.S. alone, as many as 32 million post-menopausal women suffer from VVA symptoms, providing a large patient base for the drug[1].

Revenue Projections

While specific revenue projections for Intrarosa are not detailed in recent reports, the drug's inclusion in a growing portfolio of women’s health products by companies like Cosette Pharmaceuticals and Millicent Pharma suggests a positive revenue outlook. The expansion into new territories and the robust distribution network are expected to drive sales growth[1][2].

Competitive Landscape

Intrarosa operates in a competitive market for women’s health products, particularly those addressing menopausal symptoms.

Differentiation

Its unique formulation without conventional estrogen and the absence of a boxed safety warning set it apart from competitors. This differentiation is a key selling point, especially in a market where safety concerns are paramount[1][4].

Market Share

While exact market share figures are not provided, Intrarosa's presence in almost all major markets and its distribution through multiple partners indicate a significant market presence. The drug's ability to treat a common symptom of menopause with a novel approach positions it well against other treatments like Imvexxy and Annovera[1][3].

Future Prospects

The future of Intrarosa looks promising, driven by several factors:

Expanding Global Footprint

Cosette Pharmaceuticals' plans to expand Intrarosa's reach into new territories, including Asian markets in 2025, are expected to increase its global presence and sales[1].

Strong Distribution Network

The existing distribution network and partnerships with local players will continue to support the drug's availability and accessibility in various markets[1].

Continued Investment

The backing by healthcare-focused private equity firms like Avista Capital Partners for Cosette Pharmaceuticals and The Carlyle Group for Millicent Pharma ensures that Intrarosa will benefit from continued investment in marketing, distribution, and possibly further research and development[1][2].

Key Takeaways

• Unique Formulation: Intrarosa is the only prescription drug combining estrogen and androgen without conventional pharmacological estrogen, and it does not carry a boxed safety warning.
• Acquisition History: Acquired by Millicent Pharma in 2020 and then by Cosette Pharmaceuticals in 2023, highlighting its market value.
• Market Reach: Available in major markets globally through multiple distribution partners.
• Financial Potential: Significant investment and potential for growth due to its large patient base and expanding global footprint.
• Competitive Advantage: Differentiated by its unique formulation and safety profile.

FAQs

Q: What is Intrarosa used for? A: Intrarosa is used for the treatment of moderate to severe dyspareunia, a common symptom of vulvar and vaginal atrophy (VVA) due to menopause.

Q: Who currently owns the global rights to Intrarosa? A: Cosette Pharmaceuticals, Inc. acquired the global rights to Intrarosa from Endoceutics, Inc. in June 2023.

Q: What makes Intrarosa unique compared to other hormone replacement therapies? A: Intrarosa is unique because it combines estrogen and androgen without conventional pharmacological estrogen and does not carry a boxed safety warning on its label.

Q: In which markets is Intrarosa currently available? A: Intrarosa is available in the U.S., UK, EU, Canada, Israel, and will be launched in Asian markets in 2025.

Q: What is the estimated patient base for Intrarosa in the U.S.? A: An estimated 32 million post-menopausal women in the U.S. suffer from VVA symptoms, with between 44% and 78% of these women experiencing dyspareunia.

Sources

1. Business Wire: Cosette Pharmaceuticals Acquires Intrarosa® from Endoceutics, Inc.
2. The Carlyle Group: Millicent Pharma Acquires the U.S. Commercial Rights to Intrarosa® from AMAG Pharmaceuticals
3. TherapeuticsMD Inc: Oppenheimer NDR_TXMD Final 3
4. Amboy Street Ventures: ASV Insights presents the Top 10 Deals of 2023
5. Kaiser Permanente: CRITERIA FOR DRUG COVERAGE - Intrarosa