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Details for Generic Name: nateglinide

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Nateglinide is the generic ingredient in two branded drugs marketed by Dr Reddys Labs Ltd, Par Pharm, Teva Pharms, Watson Labs, and Novartis, and is included in five NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for nateglinide. One supplier is listed for this compound.

Summary for Generic Name: nateglinide

Drug Master File Entries: see list8
Suppliers: see list1
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for Ingredient: nateglinide

Drug ClassGlinide
Mechanism of ActionPotassium Channel Antagonists

Clinical Trials for: nateglinide

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Ltd
TABLET;ORAL077461-002Sep 9, 2009RXNo<disabled><disabled>
TABLET;ORAL021204-002Dec 22, 2000RXYes6,878,749<disabled>Y<disabled>
Dr Reddys Labs Ltd
TABLET;ORAL077461-001Sep 9, 2009RXNo<disabled><disabled>
Teva Pharms
TABLET;ORAL077467-001Sep 9, 2009DISCNNo<disabled><disabled>
Watson Labs
TABLET;ORAL077462-002Mar 30, 2011RXNo<disabled><disabled>
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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