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Last Updated: August 8, 2020

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Nateglinide - Generic Drug Details

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What are the generic drug sources for nateglinide and what is the scope of patent protection?

Nateglinide is the generic ingredient in two branded drugs marketed by Alvogen, Cadila Pharms Ltd, Dr Reddys Labs Ltd, Par Pharm, Teva Pharms, Watson Labs, Wilshire Pharms Inc, Zydus Pharms, and Novartis, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for nateglinide. Ten suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for nateglinide

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Recent Clinical Trials for nateglinide

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

SponsorPhase
Zhongda HospitalPhase 4
Emory UniversityPhase 4
Canadian Institutes of Health Research (CIHR)N/A

See all nateglinide clinical trials

Generic filers with tentative approvals for NATEGLINIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial120MGTABLET;ORAL
  Start Trial  Start Trial60MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for nateglinide
Drug ClassGlinide
Mechanism of ActionPotassium Channel Antagonists
Paragraph IV (Patent) Challenges for NATEGLINIDE
Tradename Dosage Ingredient NDA Submissiondate
STARLIX TABLET;ORAL nateglinide 021204 2004-12-22

US Patents and Regulatory Information for nateglinide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs NATEGLINIDE nateglinide TABLET;ORAL 077462-002 Mar 30, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms NATEGLINIDE nateglinide TABLET;ORAL 205248-001 Jul 6, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms NATEGLINIDE nateglinide TABLET;ORAL 077467-002 Sep 9, 2009 DISCN No No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Ltd NATEGLINIDE nateglinide TABLET;ORAL 077461-002 Sep 9, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Alvogen NATEGLINIDE nateglinide TABLET;ORAL 205055-001 Dec 11, 2015 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for nateglinide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis STARLIX nateglinide TABLET;ORAL 021204-002 Dec 22, 2000   Start Trial   Start Trial
Novartis STARLIX nateglinide TABLET;ORAL 021204-001 Dec 22, 2000   Start Trial   Start Trial
Novartis STARLIX nateglinide TABLET;ORAL 021204-001 Dec 22, 2000   Start Trial   Start Trial
Novartis STARLIX nateglinide TABLET;ORAL 021204-001 Dec 22, 2000   Start Trial   Start Trial
Novartis STARLIX nateglinide TABLET;ORAL 021204-002 Dec 22, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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