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
*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 |
Anatomical Therapeutic Chemical (ATC) Classes for PRASTERONE
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 | Y | ⤷ Sign Up | |||
| Millicent | INTRAROSA | prasterone | INSERT;VAGINAL | 208470-001 | Nov 16, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 |
|---|---|---|---|
| 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 |
| Hong Kong | 1217639 | 治療絕經期的 組合物 (DEHA COMPOSITIONS FOR TREATING MENOPAUSE DEHA) | ⤷ Sign Up |
| Spain | 2888104 | ⤷ Sign Up | |
| Ukraine | 100701 | КОМПОЗИЦИИ DHEA ДЛЯ ЛЕЧЕНИЯ МЕНОПАУЗЫ;КОМПОЗИЦІЇ DHEA ДЛЯ ЛІКУВАННЯ МЕНОПАУЗИ (DHEA COMPOSITION FOR PAUSIMENIA TREATMENT) | ⤷ 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 |
