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Last Updated: August 17, 2022

STARLIX Drug Patent Profile


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Which patents cover Starlix, and what generic alternatives are available?

Starlix is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in STARLIX is nateglinide. There are nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the nateglinide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Starlix

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

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Summary for STARLIX
Drug patent expirations by year for STARLIX
Drug Prices for STARLIX

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Recent Clinical Trials for STARLIX

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

SponsorPhase
Novartis PharmaceuticalsPhase 4
Dr. Reddy's Laboratories LimitedPhase 1

See all STARLIX clinical trials

Paragraph IV (Patent) Challenges for STARLIX
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 STARLIX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis STARLIX nateglinide TABLET;ORAL 021204-001 Dec 22, 2000 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis STARLIX nateglinide TABLET;ORAL 021204-002 Dec 22, 2000 DISCN Yes 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 STARLIX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis STARLIX nateglinide TABLET;ORAL 021204-001 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 021204-001 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 021204-001 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 STARLIX

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

International Patents for STARLIX

See the table below for patents covering STARLIX around the world.

Country Patent Number Title Estimated Expiration
Germany 3683662 See Plans and Pricing
Denmark 0526171 See Plans and Pricing
Canada 2271865 PREPARATION EN COMPRIMES (TABLET COMPOSITION) See Plans and Pricing
Ukraine 92310 КОМПОЗИЦИЯ, КОТОРАЯ ВКЛЮЧАЕТ НАТЕГЛИНИД, САХАР И МИКРОКРИСТАЛЛИЧЕСКУЮ ЦЕЛЛЮЛОЗУ;КОМПОЗИЦІЯ, ЩО ВКЛЮЧАЄ НАТЕГЛІНІД, ЦУКОР ТА МІКРОКРИСТАЛІЧНУ ЦЕЛЮЛОЗУ (COMPOSITION COMPRISING NATEGLINIDE, LACTOSE MONOHYDRATE AND MICROCRYSTALLINE CELLULOSE) See Plans and Pricing
Singapore 127714 Method of treating metabolic disorders, especiallydiabetes, or a disease or condition associated wi th diabetes See Plans and Pricing
Slovakia 3602002 COMBINATION CONTAINING NATEGLINIDE AND PHARMACEUTICAL COMPOSITION COMPRISING SAID COMBINATION FOR TREATING METABOLIC DISORDERS See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for STARLIX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0196222 SPC/GB01/045 United Kingdom See Plans and Pricing PRODUCT NAME: NATEGLINIDE OR SALTS THEREOF; REGISTERED: CH 55401 20000928; CH 55402 20000928; UK EU/1/01/174/001 20010403; UK EU/1/01/174/002 20010403; UK EU/1/01/174/003 20010403; UK EU/1/01/174/004 20010403; UK EU/1/01/174/005 20010403; UK EU/1/01/174/006 20010403; UK EU/1/01/174/019 20010403; UK EU/1/01/174/020 20010403; UK EU/1/01/174/021 20010403; UK EU/1/01/174/013 20010403; UK EU/1/01/174/014 20010403; UK EU/1/01/174/015 20010403; UK EU/1/01/174/016 20010403; UK EU/1/01/174/017 20010403; UK EU/1/01/174/018 20010403; UK EU/1/01/174/007 20010403; UK EU/1/01/174/008 20010403; UK EU/1/01/174/009 20010403; UK EU/1/01/174/010 20010403; UK EU/1/01/174/011 20010403; UK EU/1/01/174/012 2001040
0526171 C300063 Netherlands See Plans and Pricing PRODUCT NAME: NATEGLINIDUM; NAT. REGISTRATION NO/DATE: EU/1/01/174/001EU/1/01/174/002EU/1/01/174/003EU/1/01/174/004EU/1/01/174/005EU/1/01/174/006EU/1/01/174/007EU/1/01/174/008EU/1/01/174/009EU/1/01/174/010EU/1/01/174/011EU/1/01/174/012EU/1/01/174/013EU/1/01/174/014EU/1/01/174/015EU/1/01/174/016EU/1/01/174/017EU/1/01/174/018EU/1/01/174/019EU/1/01/174/020EU/1/01/174/021 2001030403; FIRST REGISTRATION: EU/1/01/174/001EU/1/01/174/002EU/1/01/174/003EU/1/01/174/004EU/1/01/174/005EU/1/01/174/006EU/1/01/174/007EU/1/01/174/008EU/1/01/174/009EU/1/01/174/010EU/1/01/174/011EU/1/01/174/012EU/1/01/174/013EU/1/01/174/014EU/1/01/174/015EU/1/01/174/016EU/1/01/174/017EU/1/01/174/018EU/1/01/174/019EU/1/01/174/
0526171 31/2001 Austria See Plans and Pricing PRODUCT NAME: NATEGLINIDE; NAT. REGISTRATION NO/DATE: EU/1/01/174/001 - EU/1/01/174/021 20010403; FIRST REGISTRATION: LI 55401.01 - 02 20000928
0526171 SPC/GB01/047 United Kingdom See Plans and Pricing PRODUCT NAME: NATEGLINIDE; REGISTERED: CH 55401 01 20000928; CH 55401 02 20000928; UK EU/1/01/174/001 20010403; UK EU/1/01/174/002 20010403; UK EU/1/01/174/003 20010403; UK EU/1/01/174/004 20010403; UK EU/1/01/174/005 20010403; UK EU/1/01/174/006 20010403; UK EU/1/01/174/007 20010403; UK EU/1/01/174/008 20010403; UK EU/1/01/174/009 20010403; UK EU/1/01/174/010 20010403; UK EU/1/01/174/011 20010403; UK EU/1/01/174/012 20010403; UK EU/1/01/174/013 20010403; UK EU/1/01/174/014 20010403; UK EU/1/01/174/015 20010403; UK EU/1/01/174/016 20010403; UK EU/1/01/174/017 20010403; UK EU/1/01/174/018 20010403; UK EU/1/01/174/019 20010403; UK EU/1/01/174/020 20010403; UK EU/1/01/174/021 20010403
0526171 01C0044 France See Plans and Pricing PRODUCT NAME: NATEGLINIDE; NAT. REGISTRATION NO/DATE: EU/1/01/174/001 20010403; FIRST REGISTRATION: LI - 55401 20000928
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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