Clofibrate - Generic Drug Details
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What are the generic drug sources for clofibrate and what is the scope of freedom to operate?
Clofibrate
is the generic ingredient in two branded drugs marketed by Wyeth Ayerst, Banner Pharmacaps, Sandoz, Teva, Usl Pharma, and Watson Labs, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.There are four drug master file entries for clofibrate.
Summary for clofibrate
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 6 |
| NDAs: | 6 |
| Drug Master File Entries: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 8 |
| DailyMed Link: | clofibrate at DailyMed |
Recent Clinical Trials for clofibrate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Laboratorios Grossman, S.A. | Phase 3 |
| Instituto Nacional de Salud Publica, Mexico | Phase 3 |
| Federal University of São Paulo | Phase 4 |
Medical Subject Heading (MeSH) Categories for clofibrate
Anatomical Therapeutic Chemical (ATC) Classes for clofibrate
US Patents and Regulatory Information for clofibrate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Teva | CLOFIBRATE | clofibrate | CAPSULE;ORAL | 072600-001 | Jul 25, 1991 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Watson Labs | CLOFIBRATE | clofibrate | CAPSULE;ORAL | 071603-001 | Sep 18, 1987 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Banner Pharmacaps | CLOFIBRATE | clofibrate | CAPSULE;ORAL | 073396-001 | Mar 20, 1992 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sandoz | CLOFIBRATE | clofibrate | CAPSULE;ORAL | 072191-001 | May 2, 1988 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Wyeth Ayerst | ATROMID-S | clofibrate | CAPSULE;ORAL | 016099-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Usl Pharma | CLOFIBRATE | clofibrate | CAPSULE;ORAL | 070531-001 | Jun 16, 1986 | 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 |
