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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.

This ingredient has sixty-two patent family members in thirty-five countries.

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

Summary for Generic Name: nateglinide

Drug Master File Entries: see list9
Suppliers / Packaging: see list2
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
TABLET;ORAL021204-002Dec 22, 2000RXYes6,641,841<disabled>Y<disabled>
Par Pharm
TABLET;ORAL077463-002Sep 9, 2009RXNo<disabled><disabled>
Watson Labs
TABLET;ORAL077462-001Mar 30, 2011RXNo<disabled><disabled>
TABLET;ORAL021204-002Dec 22, 2000RXYes6,844,008<disabled>Y<disabled>
TABLET;ORAL021204-001Dec 22, 2000RXNo6,641,841<disabled>Y<disabled>
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International Patent Family for Ingredient: nateglinide

Country Document Number Publication Date
Hungary0400932Jul 28, 2004
Ukraine92310Oct 25, 2010
European Patent Office2011507Jan 07, 2009
Canada2271865May 28, 1998
Germany69740161May 12, 2011
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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ISSN: 2162-2639

Preferred citation:

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

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