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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Questions you can ask:
- What is the 5 year forecast for INTRAROSA?
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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: | 5,218 |
| Drug Prices: | Drug price information for INTRAROSA |
| What excipients (inactive ingredients) are in INTRAROSA? | INTRAROSA excipients list |
| DailyMed Link: | INTRAROSA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for INTRAROSA
*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 |
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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Pharmaceutical compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Pharmaceutical compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Millicent | INTRAROSA | prasterone | INSERT;VAGINAL | 208470-001 | Nov 16, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Millicent | INTRAROSA | prasterone | INSERT;VAGINAL | 208470-001 | Nov 16, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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
Patent: COMPOSICIONES FARMACEUTICAS
Estimated Expiration: ⤷ Sign Up
Patent: 4577
Patent: MÉTODOS PARA TRATAR O REDUCIR LA PROBABILIDAD DE ADQUIRIR SÍNTOMAS O ENFERMEDADES DEBIDAS A LA MENOPAUSIA
Estimated Expiration: ⤷ Sign Up
Patent: 4051
Patent: COMPOSICIONES FARMACÉUTICAS Y SUPOSITORIO VAGINAL
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 08286651
Patent: DHEA compositions for treating menopause
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0815353
Patent: Compoições e dhea para o tratamento da menopausa
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 96127
Patent: COMPOSITIONS DE DHEA POUR TRAITER LA MENOPAUSE (DHEA COMPOSITIONS FOR TREATING MENOPAUSE)
Estimated Expiration: ⤷ Sign Up
Patent: 20566
Patent: COMPOSITIONS DE DHEA POUR TRAITER LA MENOPAUSE (DHEA COMPOSITIONS FOR TREATING MENOPAUSE)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 08002362
Patent: 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.
Estimated Expiration: ⤷ Sign Up
China
Patent: 1861152
Patent: DEHA compositions for treating menopause
Estimated Expiration: ⤷ Sign Up
Patent: 2861335
Patent: DHEA compositions for treating menopause
Estimated Expiration: ⤷ Sign Up
Patent: 5412121
Patent: DHEA compositions for treating menopause
Estimated Expiration: ⤷ Sign Up
Patent: 9893526
Patent: 治疗绝经期的DEHA组合物 (DHEA compositions for treating menopause)
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 60084
Patent: UNA COMPOSICION FARMACEUTICA QUE COMPRENDE UN PRECURSOR DE ESTEROIDE SEXUAL DE DESHIDROEPIANDROSTERONA (DHEA)
Estimated Expiration: ⤷ Sign Up
Costa Rica
Patent: 262
Patent: COMPOSICIONES DE DHEA PARA EL TRATAMIENTO DE LA MENOPAUSIA.
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 85157
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 10010016
Patent: COMPOSICIONES DE DHEA PARA EL TRATAMIENTO DE LA MENOPAUSIA
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 0683
Patent: СПОСОБ ЛЕЧЕНИЯ ИЛИ УМЕНЬШЕНИЯ РИСКА ВОЗНИКНОВЕНИЯ СИМПТОМОВ ИЛИ ЗАБОЛЕВАНИЙ У ПОСТМЕНОПАУЗНЫХ ЖЕНЩИН, ИНТРАВАГИНАЛЬНАЯ КОМПОЗИЦИЯ И СУППОЗИТОРИЙ, ПРИМЕНЯЕМЫЕ В НЕМ (METHOD FOR TREATING OR REDUCING ACQUIRING SYMPTOMS OR DISEASES IN POSTMENOPAUSAL WOMEN, INTRAVAGINAL COMPOSITION AND SUPPOSITORY USED THEREIN)
Estimated Expiration: ⤷ Sign Up
Patent: 1000312
Patent: КОМПОЗИЦИИ DHEA ДЛЯ ЛЕЧЕНИЯ МЕНОПАУЗЫ
Estimated Expiration: ⤷ Sign Up
Patent: 1200369
Patent: ПРИМЕНЕНИЕ ПРЕДШЕСТВЕННИКОВ ПОЛОВЫХ СТЕРОИДНЫХ ГОРМОНОВ В КОМБИНАЦИИ С СЕЛЕКТИВНЫМ МОДУЛЯТОРОМ ЭСТРОГЕНОВЫХ РЕЦЕПТОРОВ ДЛЯ ЛЕЧЕНИЯ ЗАБОЛЕВАНИЙ И СОСТОЯНИЙ У ПОСТМЕНОПАУЗНЫХ ЖЕНЩИН
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 85157
Patent: COMPOSITIONS DE DHEA POUR TRAITER LA MÉNOPAUSE (DHEA COMPOSITIONS FOR TREATING MENOPAUSE)
Estimated Expiration: ⤷ Sign Up
Patent: 41456
Patent: Compositions de DHEA pour traiter la ménopause (DHEA compositions for treating menopose)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 17639
Patent: 治療絕經期的 組合物 (DEHA COMPOSITIONS FOR TREATING MENOPAUSE DEHA)
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 3747
Patent: שימוש בפרקורסור של סטרויד מין בייצור תרופה למתן 13 מ" ג או פחות למינון יומי דרך הנרתיק לטיפול מחלות נרתיקיות ותכשיר רוקחי נרתיקי המכילה אותה (Use of sex steroid precursor in the manufacture of a medicament for delivering 13 mg or less daily dosage intrvaginally for the treatment of vaginal diseases and a vaginal pharmaceutical composition comprising same)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 25283
Estimated Expiration: ⤷ Sign Up
Patent: 97292
Estimated Expiration: ⤷ Sign Up
Patent: 10535717
Estimated Expiration: ⤷ Sign Up
Patent: 13060475
Patent: DHEA COMPOSITION FOR TREATING MENOPAUSE
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 10001627
Patent: COMPOSICIONES DE DHEA PARA EL TRATAMIENTO DE LA MENOPAUSIA. (DHEA COMPOSITIONS FOR TREATING MENOPAUSE.)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 694
Patent: التراكيب dhea لعلاج انقطاع الطمث
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 3147
Patent: DEHYDROEPIANDROSTERONE COMPOSITIONS FOR TREATING MENOPAUSE
Estimated Expiration: ⤷ Sign Up
Patent: 8270
Patent: DHEA COMPOSITIONS FOR TREATING MENOPAUSE
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 100300
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 090945
Patent: COMPOSICIONES FARMACEUTICAS QUE COMPRENDEN UN PRECURSOR DE ESTEROIDES SEXUALES
Estimated Expiration: ⤷ Sign Up
Patent: 140925
Patent: COMPOSICION FARMACEUTICA QUE COMPRENDE UN PRECURSOR DE ESTEROIDES SEXUALES
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 013502291
Patent: DHEA COMPOSITIONS FOR TREATING MENOPAUSE
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 85157
Estimated Expiration: ⤷ Sign Up
Saudi Arabia
Patent: 290494
Patent: مركبات صيدلانية اندروجينية ذات تاثير استروجيني ضعيف (Androgenic Pharmaceuticals With low Estrogenic Effect)
Estimated Expiration: ⤷ Sign Up
Patent: 1320726
Patent: مركبات صيدلانية اندروجينية ذات تاثير استروجيني ضعيف (Androgenic Pharmaceuticals With low Estrogenic Effect)
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 3702
Patent: DHEA COMPOSITIONS FOR TREATING MENOPAUSE
Estimated Expiration: ⤷ Sign Up
Patent: 201601242T
Patent: DHEA COMPOSITIONS FOR TREATING MENOPAUSE
Estimated Expiration: ⤷ Sign Up
Patent: 201902375X
Patent: DHEA COMPOSITIONS FOR TREATING MENOPAUSE
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1000874
Patent: Dhea compositions for treating menopause
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1638130
Estimated Expiration: ⤷ Sign Up
Patent: 1680287
Estimated Expiration: ⤷ Sign Up
Patent: 1850125
Estimated Expiration: ⤷ Sign Up
Patent: 100061671
Patent: DHEA COMPOSITIONS FOR TREATING MENOPAUSE
Estimated Expiration: ⤷ Sign Up
Patent: 130103805
Patent: DHEA COMPOSITIONS FOR TREATING MENOPAUSE
Estimated Expiration: ⤷ Sign Up
Patent: 160032257
Patent: 폐경기 치료용 DHEA 조성물 (DHEA COMPOSITIONS FOR TREATING MENOPAUSE)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 88104
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 88328
Estimated Expiration: ⤷ Sign Up
Patent: 65468
Estimated Expiration: ⤷ Sign Up
Patent: 09688
Estimated Expiration: ⤷ Sign Up
Patent: 0927136
Patent: Pharmaceutical compositions
Estimated Expiration: ⤷ Sign Up
Patent: 1212922
Patent: DHEA compositions for treating menopause
Estimated Expiration: ⤷ Sign Up
Patent: 1634051
Patent: DHEA compositions for treating menopause
Estimated Expiration: ⤷ Sign Up
Tunisia
Patent: 10000065
Patent: DHEA COMPOSITIONS FOR TREATING MENOPAUSE
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 0701
Patent: КОМПОЗИЦИИ DHEA ДЛЯ ЛЕЧЕНИЯ МЕНОПАУЗЫ;КОМПОЗИЦІЇ DHEA ДЛЯ ЛІКУВАННЯ МЕНОПАУЗИ (DHEA COMPOSITION FOR PAUSIMENIA TREATMENT)
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| 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. | ⤷ Sign Up |
| Peru | 20090945 | COMPOSICIONES FARMACEUTICAS QUE COMPRENDEN UN PRECURSOR DE ESTEROIDES SEXUALES | ⤷ Sign Up |
| South Korea | 20100061671 | DHEA COMPOSITIONS FOR TREATING MENOPAUSE | ⤷ Sign Up |
| Peru | 20140925 | COMPOSICION FARMACEUTICA QUE COMPRENDE UN PRECURSOR DE ESTEROIDES SEXUALES | ⤷ Sign Up |
| >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 | ⤷ Sign Up | 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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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.
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