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Last Updated: October 1, 2022

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-seven patent family members in thirty-one countries.

The generic ingredient in INTRAROSA is prasterone. There are seven drug master file entries 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:57
US Patents:3
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 89
Clinical Trials: 7
Patent Applications: 4,231
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
Drug Prices for INTRAROSA

See drug prices for INTRAROSA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for INTRAROSA
Generic Entry Date for INTRAROSA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Lee's Pharmaceutical LimitedPhase 3
University of ArkansasPhase 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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of INTRAROSA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Millicent INTRAROSA prasterone INSERT;VAGINAL 208470-001 Nov 16, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Millicent INTRAROSA prasterone INSERT;VAGINAL 208470-001 Nov 16, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

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: See Plans and Pricing

Patent: 4577
Estimated Expiration: See Plans and Pricing

Patent: 4051
Estimated Expiration: See Plans and Pricing

Australia

Patent: 08286651
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0815353
Estimated Expiration: See Plans and Pricing

Canada

Patent: 96127
Estimated Expiration: See Plans and Pricing

Patent: 20566
Estimated Expiration: See Plans and Pricing

Chile

Patent: 08002362
Estimated Expiration: See Plans and Pricing

China

Patent: 1861152
Estimated Expiration: See Plans and Pricing

Patent: 2861335
Estimated Expiration: See Plans and Pricing

Patent: 5412121
Estimated Expiration: See Plans and Pricing

Patent: 9893526
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 60084
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 262
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 85157
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 10010016
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 0683
Estimated Expiration: See Plans and Pricing

Patent: 1000312
Estimated Expiration: See Plans and Pricing

Patent: 1200369
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 85157
Estimated Expiration: See Plans and Pricing

Patent: 41456
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 17639
Estimated Expiration: See Plans and Pricing

Israel

Patent: 3747
Estimated Expiration: See Plans and Pricing

Japan

Patent: 25283
Estimated Expiration: See Plans and Pricing

Patent: 97292
Estimated Expiration: See Plans and Pricing

Patent: 10535717
Estimated Expiration: See Plans and Pricing

Patent: 13060475
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 10001627
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 694
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 3147
Estimated Expiration: See Plans and Pricing

Patent: 8270
Estimated Expiration: See Plans and Pricing

Norway

Patent: 100300
Estimated Expiration: See Plans and Pricing

Peru

Patent: 090945
Estimated Expiration: See Plans and Pricing

Patent: 140925
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 013502291
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 85157
Estimated Expiration: See Plans and Pricing

Saudi Arabia

Patent: 40
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 3702
Estimated Expiration: See Plans and Pricing

Patent: 201601242T
Estimated Expiration: See Plans and Pricing

Patent: 201902375X
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1000874
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1638130
Estimated Expiration: See Plans and Pricing

Patent: 1680287
Estimated Expiration: See Plans and Pricing

Patent: 1850125
Estimated Expiration: See Plans and Pricing

Patent: 100061671
Estimated Expiration: See Plans and Pricing

Patent: 130103805
Estimated Expiration: See Plans and Pricing

Patent: 160032257
Estimated Expiration: See Plans and Pricing

Spain

Patent: 88104
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 88328
Estimated Expiration: See Plans and Pricing

Patent: 65468
Estimated Expiration: See Plans and Pricing

Patent: 09688
Estimated Expiration: See Plans and Pricing

Patent: 0927136
Estimated Expiration: See Plans and Pricing

Patent: 1212922
Estimated Expiration: See Plans and Pricing

Patent: 1634051
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 10000065
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 0701
Estimated Expiration: See Plans and Pricing

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
Argentina 104577 MÉTODOS PARA TRATAR O REDUCIR LA PROBABILIDAD DE ADQUIRIR SÍNTOMAS O ENFERMEDADES DEBIDAS A LA MENOPAUSIA See Plans and Pricing
Japan 5725283 See Plans and Pricing
Canada 2696127 COMPOSITIONS DE DHEA POUR TRAITER LA MENOPAUSE (DHEA COMPOSITIONS FOR TREATING MENOPAUSE) See Plans and Pricing
Chile 2008002362 Composicion farmaceutica vaginal que comprende menor igual que 13 mg de dehidroepiandrosterona, sulfato de dehidroepiandrosterona, androst-5-en-3beta, 17 beta-diol o 4androsten-3, 17-diona y un excipiente; kit; uso para tratar sintomas menopausicos como incontinencia urinaria, vaginitis atrofica, sequedad vaginal, dispareunia y disfuncion sexual. See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for INTRAROSA

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

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Serving leading biopharmaceutical companies globally:

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Johnson and Johnson
AstraZeneca
Boehringer Ingelheim
Moodys
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.