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Last Updated: October 19, 2020

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NATEGLINIDE Drug Profile

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US ANDA Litigation and Generic Entry Outlook for Nateglinide

A generic version of NATEGLINIDE was approved as nateglinide by DR REDDYS LABS LTD on September 9th, 2009.

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Drug patent expirations by year for NATEGLINIDE
Drug Prices for NATEGLINIDE

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Recent Clinical Trials for NATEGLINIDE

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

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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
Alvogen NATEGLINIDE nateglinide TABLET;ORAL 205055-001 Dec 11, 2015 DISCN No No   Start Trial   Start Trial   Start Trial
Par Pharm NATEGLINIDE nateglinide TABLET;ORAL 077463-001 Sep 9, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Cadila Pharms Ltd NATEGLINIDE nateglinide TABLET;ORAL 206432-002 Apr 19, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Watson Labs NATEGLINIDE nateglinide TABLET;ORAL 077462-002 Mar 30, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Par Pharm NATEGLINIDE nateglinide TABLET;ORAL 077463-002 Sep 9, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms NATEGLINIDE nateglinide TABLET;ORAL 205248-002 Jul 6, 2016 AB RX No Yes   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

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