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Profile for Tradename: STARLIX

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Starlix is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in STARLIX is nateglinide. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nateglinide profile page.

Summary for Tradename: STARLIX

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list2

Pharmacology for Tradename: STARLIX

Drug ClassGlinide
Mechanism of ActionPotassium Channel Antagonists

Clinical Trials for: STARLIX

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

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

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

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

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

A Study to Assess Safety and Efficacy of ASP1941 in Combination With Nateglinide in Type 2 Diabetic Patients
Status: Completed Condition: Type 2 Diabetes Mellitus

Efficacy and Safety of Nateglinide Treatment in Renal Transplant Recipients
Status: Completed Condition: Renal Transplant Recipients; Posttransplant Diabetes Mellitus; Posttransplant Impaired Glucose Tolerance

A Open-label, Single-dose, 2-Sequence, 2-Period, Crossover Study to Assess Safety and Pharmacokinetics of a Nateglinide/Metformin HCl Combined Tablet Compared With a Nateglinide 120 mg Tablet and Metformin HCl 500 mg Tablet Under Fasting Conditions in Healthy Male Subjects
Status: Completed Condition: Healthy Volunteers

A Pilot Study to Evaluate the Effects of Nateglinide vs. Glibenclamide on Renal Hemodynamics and Albumin Excretion
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, 2000RXNo6,559,188<disabled>Y<disabled>
Novartis
STARLIX
nateglinide
TABLET;ORAL021204-002Dec 22, 2000RXYes6,844,008<disabled>Y<disabled>
Novartis
STARLIX
nateglinide
TABLET;ORAL021204-001Dec 22, 2000RXNo6,878,749<disabled>Y<disabled>
Novartis
STARLIX
nateglinide
TABLET;ORAL021204-002Dec 22, 2000RXYes6,878,749<disabled>Y<disabled>
Novartis
STARLIX
nateglinide
TABLET;ORAL021204-001Dec 22, 2000RXNo6,641,841<disabled>Y<disabled>
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Paragraph IV activity for: STARLIX

Drugname Dosage Strength RLD Submissiondate
nateglinideTablets60 mg and 120 mgStarlix12/22/2004

Premature patent expiration for: STARLIX

Expiration due to failure to pay maintenance fee

Patent Number Tradename Expiration Date
6,559,188
STARLIX
May 06, 2015
6,878,749
STARLIX
April 12, 2013

Non-Orange Book Patents for Tradename: STARLIX

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,143,323 Tablet composition<disabled in preview>
6,296,872 Tablet composition of N-(trans-4-isopropylcyclohexanecarbonyl)-D-phenylalanine<disabled in preview>
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International Patent Family for Tradename: STARLIX

Country Document Number Publication Date
Finland20010683Apr 02, 2001
Norway20021197May 16, 2002
Brazil0014525Jun 11, 2002
TaiwanI278311Apr 11, 2007
Israel148168Sep 12, 2002
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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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