Glutethimide - Generic Drug Details
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What are the generic sources for glutethimide and what is the scope of freedom to operate?
Glutethimide
is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us, Halsey, Lannett, Ucb Inc, Upsher Smith Labs, Vitarine, and Watson Labs, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.There are four drug master file entries for glutethimide.
Summary for glutethimide
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 7 |
| NDAs: | 10 |
| Drug Master File Entries: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 25 |
| Clinical Trials: | 2 |
| Patent Applications: | 5,090 |
| DailyMed Link: | glutethimide at DailyMed |
Recent Clinical Trials for glutethimide
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | Phase 4 |
| Federal University of São Paulo | Phase 4 |
| Melbourne Health | Phase 3 |
Medical Subject Heading (MeSH) Categories for glutethimide
Anatomical Therapeutic Chemical (ATC) Classes for glutethimide
US Patents and Regulatory Information for glutethimide
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Watson Labs | GLUTETHIMIDE | glutethimide | TABLET;ORAL | 084362-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Halsey | GLUTETHIMIDE | glutethimide | TABLET;ORAL | 089458-001 | Oct 10, 1986 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Upsher Smith Labs | GLUTETHIMIDE | glutethimide | TABLET;ORAL | 083234-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Lannett | GLUTETHIMIDE | glutethimide | TABLET;ORAL | 083475-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sanofi Aventis Us | DORIDEN | glutethimide | TABLET;ORAL | 009519-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Watson Labs | GLUTETHIMIDE | glutethimide | TABLET;ORAL | 085763-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ 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 |
