Prasterone - Generic Drug Details
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What are the generic sources for prasterone and what is the scope of freedom to operate?
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 |
| AMAG Pharmaceuticals, Inc. | Phase 2 |
| University of Arkansas | 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 | ⤷ 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 | |||
| Millicent | INTRAROSA | prasterone | INSERT;VAGINAL | 208470-001 | Nov 16, 2016 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 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 |
|---|---|---|---|
| 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 | |
| >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 | ⤷ 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 |
