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STARLIX Drug Profile

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Starlix is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge.

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

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.

Summary for Tradename: STARLIX

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list1

Pharmacology for Tradename: STARLIX

Drug ClassGlinide
Mechanism of ActionPotassium Channel Antagonists

Clinical Trials for: STARLIX

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
STARLIX
nateglinide
TABLET;ORAL021204-001Dec 22, 2000RXNo6,559,188<disabled>Y <disabled>
Novartis
STARLIX
nateglinide
TABLET;ORAL021204-002Dec 22, 2000RXYes6,844,008<disabled>Y <disabled>
Novartis
STARLIX
nateglinide
TABLET;ORAL021204-001Dec 22, 2000RXNo6,878,749<disabled>Y <disabled>
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Expired Patents for Tradename: STARLIX

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
STARLIX
nateglinide
TABLET;ORAL021204-001Dec 22, 2000RE34878<disabled>
Novartis
STARLIX
nateglinide
TABLET;ORAL021204-001Dec 22, 20005,463,116<disabled>
Novartis
STARLIX
nateglinide
TABLET;ORAL021204-002Dec 22, 20005,488,150<disabled>
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Paragraph IV activity for: STARLIX

Drugname Dosage Strength RLD Submissiondate
nateglinideTablets60 mg and 120 mgStarlix12/22/2004

Premature patent expiration for: STARLIX

Expiration due to failure to pay maintenance fee

Patent Number Tradename Expiration Date
6,559,188
STARLIX
May 06, 2015
6,878,749
STARLIX
April 12, 2013

Non-Orange Book Patents for Tradename: 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<disabled in preview>
6,296,872 Tablet composition of N-(trans-4-isopropylcyclohexanecarbonyl)-D-phenylalanine<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: STARLIX

Country Document Number Estimated Expiration
Japan2003509457<disabled in preview>
South Africa200202107<disabled in preview>
European Patent Office2277517<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: STARLIX

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB01/045United Kingdom<disabled>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
/2001Austria<disabled>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
C0044France<disabled>PRODUCT NAME: NATEGLINIDE; NAT. REGISTRATION NO/DATE: EU/1/01/174/001 20010403; FIRST REGISTRATION: LI - 55401 20000928
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