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Last Updated: July 11, 2020

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STARLIX Drug Profile


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When do Starlix patents expire, 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. Ten suppliers are listed for this compound. Additional details are available on the nateglinide profile page.

US ANDA 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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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

Pharmacology for STARLIX
Drug ClassGlinide
Mechanism of ActionPotassium Channel Antagonists
Paragraph IV (Patent) Challenges for STARLIX
Tradename Dosage Ingredient NDA Submissiondate
STARLIX TABLET;ORAL nateglinide 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   Start Trial   Start Trial   Start Trial
Novartis STARLIX nateglinide TABLET;ORAL 021204-002 Dec 22, 2000 DISCN Yes No   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

Expired US Patents for STARLIX

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

Supplementary Protection Certificates for STARLIX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0196222 SPC/GB01/045 United Kingdom   Start Trial 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   Start Trial 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 SPC/GB01/047 United Kingdom   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Johnson and Johnson
Merck
Harvard Business School
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Dow

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