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-seven 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: | 57 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 7 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 92 |
| Clinical Trials: | 17 |
| Patent Applications: | 6,805 |
| What excipients (inactive ingredients) are in prasterone? | prasterone excipients list |
| DailyMed Link: | prasterone at DailyMed |
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 | 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 | 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 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 |
|---|---|---|---|
| Denmark | 2185157 | See Plans and Pricing | |
| European Patent Office | 2441456 | Compositions de DHEA pour traiter la ménopause (DHEA compositions for treating menopose) | See Plans and Pricing |
| China | 102861335 | DHEA compositions for treating menopause | See Plans and Pricing |
| Japan | 2013060475 | DHEA COMPOSITION FOR TREATING MENOPAUSE | See Plans and Pricing |
| Japan | 6197292 | See Plans and Pricing | |
| >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 | 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 |
