You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 5, 2024

NATEGLINIDE - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic 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, Rising, Strides Pharma, Teva Pharms, Watson Labs, 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. Eleven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for NATEGLINIDE
Drug Prices for NATEGLINIDE

See drug prices for NATEGLINIDE

Recent Clinical Trials for NATEGLINIDE

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

SponsorPhase
Ministry of Health, KuwaitPhase 4
Dasman Diabetes InstitutePhase 4
Kuwait UniversityPhase 4

See all NATEGLINIDE clinical trials

Generic filers with tentative approvals for NATEGLINIDE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up120MGTABLET;ORAL
⤷  Sign Up⤷  Sign Up60MGTABLET;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 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 205055-002 Dec 11, 2015 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cadila Pharms Ltd NATEGLINIDE nateglinide TABLET;ORAL 206432-001 Apr 19, 2019 AB RX No No ⤷  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
Dr Reddys Labs Ltd NATEGLINIDE nateglinide TABLET;ORAL 077461-002 Sep 9, 2009 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
Novartis STARLIX nateglinide TABLET;ORAL 021204-002 Dec 22, 2000 DISCN Yes 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

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

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.