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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

Tradenames:2
Patents:4
Applicants:5
NDAs:5
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

Study of the Durability of Glycemic Control With Nateglinide
Status: Recruiting Condition: Type 2 Diabetes Mellitus

Long-term Study of Nateglinide+Valsartan to Prevent or Delay Type II Diabetes Mellitus and Cardiovascular Complications
Status: Completed Condition: Diabetes Mellitus, Type 2

Effects of Nateglinide vs Acarbose on Postprandial Glucose Fluctuation, Dyslipidemia, and Inflammatory Factors
Status: Completed Condition: Diabetes Mellitus, Type 2

Bioequivalence Study of Nateglinide Tablets 120 mg of Dr. Reddy's Laboratories Limited Under Fed Condition
Status: Completed Condition: Healthy

Bioequivalence Study of Nateglinide Tablets 120 mg of Dr. Reddy's Laboratories Limited Under Fasting Condition
Status: Completed Condition: Healthy

Effects of Nateglinide on Postprandial Glucose Excursion by Restoring Early Phase Insulin Secretion
Status: Completed Condition: Diabetes Mellitus, Type 2

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
STARLIX
nateglinide
TABLET;ORAL021204-001Dec 22, 2000RXNo6,641,841<disabled>Y<disabled>
Par Pharm
NATEGLINIDE
nateglinide
TABLET;ORAL077463-002Sep 9, 2009RXNo<disabled><disabled>
Teva Pharms
NATEGLINIDE
nateglinide
TABLET;ORAL077467-001Sep 9, 2009DISCNNo<disabled><disabled>
Watson Labs
NATEGLINIDE
nateglinide
TABLET;ORAL077462-002Mar 30, 2011RXNo<disabled><disabled>
Novartis
STARLIX
nateglinide
TABLET;ORAL021204-001Dec 22, 2000RXNo6,844,008<disabled>Y<disabled>
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International Patent Family for Ingredient: nateglinide

Country Document Number Publication Date
European Patent Office0965339Apr 23, 2003
Japan4171091Oct 22, 2008
European Patent Office0965339Apr 05, 2006
South Korea20000053312Aug 25, 2000
Japan2006335767Dec 14, 2006
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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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