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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 Amag Pharms Inc 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-three patent family members in twenty-eight countries.
There are seven drug master file entries for prasterone. One supplier is listed for this compound.
Summary for prasterone
| International Patents: | 53 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 7 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 83 |
| Clinical Trials: | 13 |
| Patent Applications: | 5,865 |
| DailyMed Link: | prasterone at DailyMed |
Recent Clinical Trials for prasterone
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| AMAG Pharmaceuticals, Inc. | Phase 2 |
| University of Arkansas | Phase 2 |
| Olivia Cardenas-Trowers, M.D. | Phase 3 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amag Pharms Inc | INTRAROSA | prasterone | INSERT;VAGINAL | 208470-001 | Nov 16, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Amag Pharms Inc | INTRAROSA | prasterone | INSERT;VAGINAL | 208470-001 | Nov 16, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Amag Pharms Inc | INTRAROSA | prasterone | INSERT;VAGINAL | 208470-001 | Nov 16, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Amag Pharms Inc | INTRAROSA | prasterone | INSERT;VAGINAL | 208470-001 | Nov 16, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for prasterone
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 102861335 | Start Trial |
| Colombia | 6260084 | Start Trial |
| Philippines | 12013502291 | Start Trial |
| Morocco | 31694 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
