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Nateglinide - Generic Drug Details

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Nateglinide is the generic ingredient in two branded drugs marketed by Novartis, Zydus Pharms Usa Inc, Alvogen Malta, Dr Reddys Labs Ltd, Watson Labs, Par Pharm, and Teva Pharms, and is included in seven NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are nine drug master file entries for nateglinide. Nine suppliers are listed for this compound.

Summary for Generic Name: nateglinide

Tradenames:2
Patents:4
Applicants:7
NDAs:7
Drug Master File Entries: see list9
Suppliers / Packaging: see list9
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details

Pharmacology for Ingredient: nateglinide

Drug ClassGlinide
Mechanism of ActionPotassium Channel Antagonists

Clinical Trials for: nateglinide

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zydus Pharms Usa Inc
NATEGLINIDE
nateglinide
TABLET;ORAL205248-002Jul 6, 2016RXNo<disabled><disabled>
Par Pharm
NATEGLINIDE
nateglinide
TABLET;ORAL077463-001Sep 9, 2009RXNo<disabled><disabled>
Novartis
STARLIX
nateglinide
TABLET;ORAL021204-001Dec 22, 2000RXNo6,878,749<disabled>Y <disabled>
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Expired Orange Book Patents for Generic Ingredient: nateglinide

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
STARLIX
nateglinide
TABLET;ORAL021204-002Dec 22, 20005,463,116<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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Non-Orange Book Patents for Generic Ingredient: nateglinide

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
6,296,872 Tablet composition of N-(trans-4-isopropylcyclohexanecarbonyl)-D-phenylalanine<disabled in preview>
6,143,323 Tablet composition<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 Ingredient: nateglinide

Country Document Number Estimated Expiration
Malaysia143051<disabled in preview>
European Patent Office2011507<disabled in preview>
Australia7904400<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: NATEGLINIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0044France<disabled>PRODUCT NAME: NATEGLINIDE; NAT. REGISTRATION NO/DATE: EU/1/01/174/001 20010403; FIRST REGISTRATION: LI - 55401 20000928
C/GB01/047United Kingdom<disabled>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
/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
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