Dydrogesterone - Generic Drug Details
✉ Email this page to a colleague
What are the generic drug sources for dydrogesterone and what is the scope of freedom to operate?
Dydrogesterone
is the generic ingredient in one branded drug marketed by Solvay and is included in one NDA. Additional information is available in the individual branded drug profile pages.There is one drug master file entry for dydrogesterone.
Summary for dydrogesterone
US Patents: | 0 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 65 |
Clinical Trials: | 51 |
Patent Applications: | 2,862 |
Formulation / Manufacturing: | see details |
DailyMed Link: | dydrogesterone at DailyMed |
Recent Clinical Trials for dydrogesterone
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Bezmialem Vakif University | N/A |
Zagazig University | N/A |
El Shatby University Hospital for Obstetrics and Gynecology | Phase 2/Phase 3 |
Medical Subject Heading (MeSH) Categories for dydrogesterone
US Patents and Regulatory Information for dydrogesterone
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Solvay | GYNOREST | dydrogesterone | TABLET;ORAL | 017388-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Solvay | GYNOREST | dydrogesterone | TABLET;ORAL | 017388-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ 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 |