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:	5,090
DailyMed Link:	GLUTETHIMIDE at DailyMed

Recent Clinical Trials for GLUTETHIMIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Federal University of São Paulo	Phase 4
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4
Eastern Health	Phase 3

See all GLUTETHIMIDE clinical trials

Medical Subject Heading (MeSH) Categories for GLUTETHIMIDE

Hypnotics and Sedatives

Anatomical Therapeutic Chemical (ATC) Classes for GLUTETHIMIDE

N05CE	Piperidinedione derivatives
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for GLUTETHIMIDE

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Glossary

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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
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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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