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Last Updated: November 29, 2022

Nateglinide - Generic Drug Details


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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. Nine 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
Dasman Diabetes InstitutePhase 4
Kuwait UniversityPhase 4
Texas Diabetes InstitutePhase 4

See all nateglinide clinical trials

Generic filers with tentative approvals for NATEGLINIDE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing120MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing60MGTABLET;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 Action Potassium 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
Zydus Pharms NATEGLINIDE nateglinide TABLET;ORAL 205248-002 Jul 6, 2016 AB RX No Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alvogen NATEGLINIDE nateglinide TABLET;ORAL 205055-001 Dec 11, 2015 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva Pharms NATEGLINIDE nateglinide TABLET;ORAL 077467-002 Sep 9, 2009 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Strides Pharma NATEGLINIDE nateglinide TABLET;ORAL 077463-001 Sep 9, 2009 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva Pharms NATEGLINIDE nateglinide TABLET;ORAL 077467-001 Sep 9, 2009 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Novartis STARLIX nateglinide TABLET;ORAL 021204-001 Dec 22, 2000 See Plans and Pricing See Plans and Pricing
Novartis STARLIX nateglinide TABLET;ORAL 021204-002 Dec 22, 2000 See Plans and Pricing See Plans and Pricing
Novartis STARLIX nateglinide TABLET;ORAL 021204-002 Dec 22, 2000 See Plans and Pricing See Plans and Pricing
Novartis STARLIX nateglinide TABLET;ORAL 021204-001 Dec 22, 2000 See Plans and Pricing See Plans and Pricing
>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

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