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INTRAROSA Drug Patent Profile

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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

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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:	4,548
Drug Prices:	Drug price information for INTRAROSA
What excipients (inactive ingredients) are in INTRAROSA?	INTRAROSA excipients list
DailyMed Link:	INTRAROSA at DailyMed

Drug patent expirations by year for INTRAROSA

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

Generic Entry Date for INTRAROSA^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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

Anatomical Therapeutic Chemical (ATC) Classes for INTRAROSA

A14AA	Androstan derivatives
A14A	ANABOLIC STEROIDS
A14	ANABOLIC AGENTS FOR SYSTEMIC USE
A	Alimentary tract and metabolism

G03XX	Other sex hormones and modulators of the genital system
G03X	OTHER SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for INTRAROSA

INTRAROSA is protected by three US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of INTRAROSA is ⤷ Try a Trial.

This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting INTRAROSA

Pharmaceutical compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Pharmaceutical compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: INTRAVAGINAL PRASTERONE (DEHYDROEPIANDROSTERONE) AT A DAILY DOSE OF 6.5MG FOR THE TREATMENT OF DYSPAREUNIA, A SYMPTOM OF VULVAR AND VAGINAL ATROPHY, DUE TO MENOPAUSE

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Millicent	INTRAROSA	prasterone	INSERT;VAGINAL	208470-001	Nov 16, 2016		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Millicent	INTRAROSA	prasterone	INSERT;VAGINAL	208470-001	Nov 16, 2016		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

EU/EMA Drug Approvals for INTRAROSA

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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

Patent: 8702
Estimated Expiration: ⤷ Try a Trial

Patent: 4577
Estimated Expiration: ⤷ Try a Trial

Patent: 4051
Estimated Expiration: ⤷ Try a Trial

Australia

Patent: 08286651
Estimated Expiration: ⤷ Try a Trial

Brazil

Patent: 0815353
Estimated Expiration: ⤷ Try a Trial

Canada

Patent: 96127
Estimated Expiration: ⤷ Try a Trial

Patent: 20566
Estimated Expiration: ⤷ Try a Trial

Chile

Patent: 08002362
Estimated Expiration: ⤷ Try a Trial

China

Patent: 1861152
Estimated Expiration: ⤷ Try a Trial

Patent: 2861335
Estimated Expiration: ⤷ Try a Trial

Patent: 5412121
Estimated Expiration: ⤷ Try a Trial

Patent: 9893526
Estimated Expiration: ⤷ Try a Trial

Colombia

Patent: 60084
Estimated Expiration: ⤷ Try a Trial

Costa Rica

Patent: 262
Estimated Expiration: ⤷ Try a Trial

Denmark

Patent: 85157
Estimated Expiration: ⤷ Try a Trial

Ecuador

Patent: 10010016
Estimated Expiration: ⤷ Try a Trial

Eurasian Patent Organization

Patent: 0683
Estimated Expiration: ⤷ Try a Trial

Patent: 1000312
Estimated Expiration: ⤷ Try a Trial

Patent: 1200369
Estimated Expiration: ⤷ Try a Trial

European Patent Office

Patent: 85157
Estimated Expiration: ⤷ Try a Trial

Patent: 41456
Estimated Expiration: ⤷ Try a Trial

Hong Kong

Patent: 17639
Estimated Expiration: ⤷ Try a Trial

Israel

Patent: 3747
Estimated Expiration: ⤷ Try a Trial

Japan

Patent: 25283
Estimated Expiration: ⤷ Try a Trial

Patent: 97292
Estimated Expiration: ⤷ Try a Trial

Patent: 10535717
Estimated Expiration: ⤷ Try a Trial

Patent: 13060475
Estimated Expiration: ⤷ Try a Trial

Mexico

Patent: 10001627
Estimated Expiration: ⤷ Try a Trial

Morocco

Patent: 694
Estimated Expiration: ⤷ Try a Trial

New Zealand

Patent: 3147
Estimated Expiration: ⤷ Try a Trial

Patent: 8270
Estimated Expiration: ⤷ Try a Trial

Norway

Patent: 100300
Estimated Expiration: ⤷ Try a Trial

Peru

Patent: 090945
Estimated Expiration: ⤷ Try a Trial

Patent: 140925
Estimated Expiration: ⤷ Try a Trial

Philippines

Patent: 013502291
Estimated Expiration: ⤷ Try a Trial

Portugal

Patent: 85157
Estimated Expiration: ⤷ Try a Trial

Saudi Arabia

Patent: 290494
Estimated Expiration: ⤷ Try a Trial

Patent: 1320726
Estimated Expiration: ⤷ Try a Trial

Singapore

Patent: 3702
Estimated Expiration: ⤷ Try a Trial

Patent: 201601242T
Estimated Expiration: ⤷ Try a Trial

Patent: 201902375X
Estimated Expiration: ⤷ Try a Trial

South Africa

Patent: 1000874
Estimated Expiration: ⤷ Try a Trial

South Korea

Patent: 1638130
Estimated Expiration: ⤷ Try a Trial

Patent: 1680287
Estimated Expiration: ⤷ Try a Trial

Patent: 1850125
Estimated Expiration: ⤷ Try a Trial

Patent: 100061671
Estimated Expiration: ⤷ Try a Trial

Patent: 130103805
Estimated Expiration: ⤷ Try a Trial

Patent: 160032257
Estimated Expiration: ⤷ Try a Trial

Spain

Patent: 88104
Estimated Expiration: ⤷ Try a Trial

Taiwan

Patent: 88328
Estimated Expiration: ⤷ Try a Trial

Patent: 65468
Estimated Expiration: ⤷ Try a Trial

Patent: 09688
Estimated Expiration: ⤷ Try a Trial

Patent: 0927136
Estimated Expiration: ⤷ Try a Trial

Patent: 1212922
Estimated Expiration: ⤷ Try a Trial

Patent: 1634051
Estimated Expiration: ⤷ Try a Trial

Tunisia

Patent: 10000065
Estimated Expiration: ⤷ Try a Trial

Ukraine

Patent: 0701
Estimated Expiration: ⤷ Try a Trial

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.

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Country	Patent Number	Title	Estimated Expiration
New Zealand	598270	DHEA COMPOSITIONS FOR TREATING MENOPAUSE	⤷ Try a Trial
Ecuador	SP10010016	COMPOSICIONES DE DHEA PARA EL TRATAMIENTO DE LA MENOPAUSIA	⤷ Try a Trial
Denmark	2185157		⤷ Try a Trial
China	102861335	DHEA compositions for treating menopause	⤷ Try a Trial
Singapore	183702	DHEA COMPOSITIONS FOR TREATING MENOPAUSE	⤷ Try a Trial
South Korea	20100061671	DHEA COMPOSITIONS FOR TREATING MENOPAUSE	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for INTRAROSA

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

Indicators of Generic Entry

Summary for INTRAROSA

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

Recent Clinical Trials for INTRAROSA

Anatomical Therapeutic Chemical (ATC) Classes for INTRAROSA

Patents protecting INTRAROSA

When does loss-of-exclusivity occur for INTRAROSA?

Make Better Decisions: Try a trial or see plans & pricing

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