Glutethimide - Generic Drug Details
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What are the generic drug 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: | 5,427 |
Formulation / Manufacturing: | see details |
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 |
Eastern Health | Phase 3 |
Medical Subject Heading (MeSH) Categories 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Halsey | GLUTETHIMIDE | glutethimide | TABLET;ORAL | 089459-001 | Oct 10, 1986 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Halsey | GLUTETHIMIDE | glutethimide | TABLET;ORAL | 089458-001 | Oct 10, 1986 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Vitarine | GLUTETHIMIDE | glutethimide | TABLET;ORAL | 087297-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Lannett | GLUTETHIMIDE | glutethimide | TABLET;ORAL | 083475-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Watson Labs | GLUTETHIMIDE | glutethimide | TABLET;ORAL | 085763-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Lannett | GLUTETHIMIDE | glutethimide | TABLET;ORAL | 085571-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Sanofi Aventis Us | DORIDEN | glutethimide | TABLET;ORAL | 009519-002 | Approved Prior to Jan 1, 1982 | DISCN | No | 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 |