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Last Updated: November 5, 2024

NATEGLINIDE Drug Patent Profile


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DrugPatentWatch® 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
Texas Diabetes InstitutePhase 4
Ministry of Health, KuwaitPhase 4
Dasman Diabetes InstitutePhase 4

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Pharmacology for NATEGLINIDE
Drug ClassGlinide
Mechanism of ActionPotassium Channel Antagonists
Paragraph IV (Patent) Challenges for NATEGLINIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
STARLIX Tablets nateglinide 60 mg and 120 mg 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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rising NATEGLINIDE nateglinide TABLET;ORAL 205544-001 Jun 18, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cadila Pharms Ltd NATEGLINIDE nateglinide TABLET;ORAL 206432-002 Apr 19, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Teva Pharms NATEGLINIDE nateglinide TABLET;ORAL 077467-002 Sep 9, 2009 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Rising NATEGLINIDE nateglinide TABLET;ORAL 205544-002 Jun 18, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms NATEGLINIDE nateglinide TABLET;ORAL 205248-002 Jul 6, 2016 AB RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Watson Labs NATEGLINIDE nateglinide TABLET;ORAL 077462-002 Mar 30, 2011 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for NATEGLINIDE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Novartis Europharm Limited Starlix nateglinide EMEA/H/C/000335
Nateglinide is indicated for combination therapy with metformin in type-2 diabetic patients inadequately controlled despite a maximally tolerated dose of metformin alone.
Withdrawn no no no 2001-04-03
Novartis Europharm Ltd. Trazec nateglinide EMEA/H/C/000383
Nateglinide is indicated for combination therapy with metformin in type 2 diabetic patients inadequately controlled despite a maximally tolerated dose of metformin alone.
Withdrawn no no no 2001-04-03
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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