PRASTERONE - Generic Drug Details
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What are the generic sources for prasterone and what is the scope of patent protection?
Prasterone
is the generic ingredient in one branded drug marketed by Millicent and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Prasterone has fifty-eight patent family members in thirty-one countries.
There are seven drug master file entries for prasterone. One supplier is listed for this compound.
Summary for PRASTERONE
International Patents: | 58 |
US Patents: | 3 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 7 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 98 |
Clinical Trials: | 17 |
Patent Applications: | 6,792 |
What excipients (inactive ingredients) are in PRASTERONE? | PRASTERONE excipients list |
DailyMed Link: | PRASTERONE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for PRASTERONE
Generic Entry Date for PRASTERONE*:
Constraining patent/regulatory exclusivity:
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 PRASTERONE
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 PRASTERONE
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 | Y | ⤷ Sign Up | |||
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 | |||
>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 PRASTERONE
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 PRASTERONE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Costa Rica | 11262 | COMPOSICIONES DE DHEA PARA EL TRATAMIENTO DE LA MENOPAUSIA. | ⤷ Sign Up |
China | 109893526 | 治疗绝经期的DEHA组合物 (DHEA compositions for treating menopause) | ⤷ Sign Up |
Eurasian Patent Organization | 020683 | 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) | ⤷ Sign Up |
Taiwan | 200927136 | Pharmaceutical compositions | ⤷ Sign Up |
European Patent Office | 2441456 | Compositions de DHEA pour traiter la ménopause (DHEA compositions for treating menopose) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PRASTERONE
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 |