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Serving leading biopharmaceutical companies globally:

Colorcon
Dow
Healthtrust
Federal Trade Commission
Covington
AstraZeneca
Teva
Express Scripts
Moodys
Argus Health

Generated: January 19, 2018

DrugPatentWatch Database Preview

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. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-five patent family members in thirty-five countries.

The generic ingredient in STARLIX is nateglinide. There are nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the nateglinide profile page.
Summary for STARLIX
Drug patent expirations by year for STARLIX
Pharmacology for STARLIX
Drug ClassGlinide
Mechanism of ActionPotassium Channel Antagonists

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 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis STARLIX nateglinide TABLET;ORAL 021204-002 Dec 22, 2000 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis STARLIX nateglinide TABLET;ORAL 021204-001 Dec 22, 2000 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis STARLIX nateglinide TABLET;ORAL 021204-002 Dec 22, 2000 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis STARLIX nateglinide TABLET;ORAL 021204-001 Dec 22, 2000 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis STARLIX nateglinide TABLET;ORAL 021204-001 Dec 22, 2000 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis STARLIX nateglinide TABLET;ORAL 021204-002 Dec 22, 2000 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Novartis STARLIX nateglinide TABLET;ORAL 021204-002 Dec 22, 2000 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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

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Paragraph IV (Patent) Challenges for STARLIX
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 60 mg and 120 mg ➤ Subscribe 12/22/2004

Premature patent expiration for: STARLIX

Expiration due to failure to pay maintenance fee

Patent Number Tradename Expiration Date
➤ Subscribe STARLIX ➤ Subscribe
➤ Subscribe STARLIX ➤ Subscribe

Non-Orange Book US Patents for STARLIX

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,143,323 Tablet composition ➤ Subscribe
6,296,872 Tablet composition of N-(trans-4-isopropylcyclohexanecarbonyl)-D-phenylalanine ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for STARLIX

Supplementary Protection Certificates for STARLIX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0044 France ➤ Subscribe PRODUCT NAME: NATEGLINIDE; NAT. REGISTRATION NO/DATE: EU/1/01/174/001 20010403; FIRST REGISTRATION: LI - 55401 20000928
C/GB01/047 United Kingdom ➤ Subscribe 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
C/GB01/045 United Kingdom ➤ Subscribe 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
/2001 Austria ➤ Subscribe 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

US Army
Harvard Business School
McKinsey
US Department of Justice
UBS
Julphar
Accenture
Johnson and Johnson
Dow

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