CLOFIBRATE - Generic Drug Details

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What are the generic drug sources for clofibrate and what is the scope of patent protection?

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.

Sponsor	Phase
Laboratorios Grossman, S.A.	Phase 3
Instituto Nacional de Salud Publica, Mexico	Phase 3
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4

Sponsor

Phase

Laboratorios Grossman, S.A.

Phase 3

Instituto Nacional de Salud Publica, Mexico

Phase 3

Fundação de Amparo à Pesquisa do Estado de São Paulo

Phase 4

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Banner Pharmacaps	CLOFIBRATE	clofibrate	CAPSULE;ORAL	073396-001	Mar 20, 1992		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
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

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