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Serving 500+ biopharmaceutical companies globally:

Covington
Harvard Business School
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Medtronic
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US Army
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Generated: July 22, 2017

DrugPatentWatch Database Preview

STARLIX Drug Profile

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What is the patent landscape for Starlix, and what generic Starlix 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-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. Twelve 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
Bulk Api Vendors: see list54
Clinical Trials: see list3
Patent Applications: see list4,623
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:STARLIX at DailyMed

Pharmacology for Tradename: STARLIX

Drug ClassGlinide
Mechanism of ActionPotassium Channel Antagonists
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;ORAL021204-001Dec 22, 2000ABRXYesNo6,878,749► SubscribeY ► Subscribe
Novartis
STARLIX
nateglinide
TABLET;ORAL021204-002Dec 22, 2000ABRXYesYes6,641,841► SubscribeY ► Subscribe
Novartis
STARLIX
nateglinide
TABLET;ORAL021204-001Dec 22, 2000ABRXYesNo6,559,188► SubscribeY ► Subscribe
Novartis
STARLIX
nateglinide
TABLET;ORAL021204-002Dec 22, 2000ABRXYesYes6,559,188► SubscribeY ► Subscribe
Novartis
STARLIX
nateglinide
TABLET;ORAL021204-001Dec 22, 2000ABRXYesNo6,844,008► SubscribeY ► Subscribe
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Expired Patents for Tradename: STARLIX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
STARLIX
nateglinide
TABLET;ORAL021204-001Dec 22, 20005,463,116► Subscribe
Novartis
STARLIX
nateglinide
TABLET;ORAL021204-001Dec 22, 2000RE34878► Subscribe
Novartis
STARLIX
nateglinide
TABLET;ORAL021204-002Dec 22, 2000RE34878► Subscribe
Novartis
STARLIX
nateglinide
TABLET;ORAL021204-001Dec 22, 20005,488,150► Subscribe
Novartis
STARLIX
nateglinide
TABLET;ORAL021204-002Dec 22, 20005,488,150► Subscribe
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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
► Subscribe
STARLIX
► Subscribe
► Subscribe
STARLIX
► Subscribe

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► Subscribe
6,296,872 Tablet composition of N-(trans-4-isopropylcyclohexanecarbonyl)-D-phenylalanine► Subscribe
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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
Japan2006335767► Subscribe
Taiwan200401631► Subscribe
Japan4171091► Subscribe
Austria322260► Subscribe
Singapore127714► Subscribe
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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
/2001Austria► SubscribePRODUCT NAME: NATEGLINIDE; NAT. REGISTRATION NO/DATE: EU/1/01/174/001 - EU/1/01/174/021 20010403; FIRST REGISTRATION: LI 55401.01 - 02 20000928
C/GB01/047United Kingdom► SubscribePRODUCT 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
C0044France► SubscribePRODUCT NAME: NATEGLINIDE; NAT. REGISTRATION NO/DATE: EU/1/01/174/001 20010403; FIRST REGISTRATION: LI - 55401 20000928
C/GB01/045United Kingdom► SubscribePRODUCT 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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Teva
Harvard Business School
Queensland Health
Moodys
Federal Trade Commission
US Army
Daiichi Sankyo
Chinese Patent Office
UBS
McKinsey

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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