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Serving leading biopharmaceutical companies globally:

Baxter
Express Scripts
US Army
Boehringer Ingelheim
Deloitte
US Department of Justice
Johnson and Johnson
Mallinckrodt
Medtronic
Accenture

Generated: January 16, 2018

DrugPatentWatch Database Preview

Nateglinide - Generic Drug Details

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What are the generic sources for nateglinide and what is the scope of nateglinide freedom to operate?

Nateglinide
is the generic ingredient in two branded drugs marketed by Alvogen Malta, Dr Reddys Labs Ltd, Par Pharm, Teva Pharms, Watson Labs, Zydus Pharms Usa Inc, and Novartis, 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.

Nateglinide has sixty-five patent family members in thirty-five countries and four supplementary protection certificates in three countries.

There are nine drug master file entries for nateglinide. Twelve suppliers are listed for this compound. There is one tentative approval for this compound.
Pharmacology for nateglinide
Drug ClassGlinide
Mechanism of ActionPotassium Channel Antagonists
Tentative approvals for NATEGLINIDE
Applicant Application No. Strength Dosage Form
➤ Subscribe➤ Subscribe60MGTABLET;ORAL
➤ Subscribe➤ Subscribe120MGTABLET;ORAL

US Patents and Regulatory Information for nateglinide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms NATEGLINIDE nateglinide TABLET;ORAL 077467-001 Sep 9, 2009 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Novartis STARLIX nateglinide TABLET;ORAL 021204-001 Dec 22, 2000 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Watson Labs NATEGLINIDE nateglinide TABLET;ORAL 077462-001 Mar 30, 2011 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Novartis STARLIX nateglinide TABLET;ORAL 021204-002 Dec 22, 2000 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Dr Reddys Labs Ltd NATEGLINIDE nateglinide TABLET;ORAL 077461-001 Sep 9, 2009 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Zydus Pharms Usa Inc NATEGLINIDE nateglinide TABLET;ORAL 205248-001 Jul 6, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Par Pharm NATEGLINIDE nateglinide TABLET;ORAL 077463-001 Sep 9, 2009 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Novartis STARLIX nateglinide TABLET;ORAL 021204-002 Dec 22, 2000 AB RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Alvogen Malta NATEGLINIDE nateglinide TABLET;ORAL 205055-002 Dec 11, 2015 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Par Pharm NATEGLINIDE nateglinide TABLET;ORAL 077463-002 Sep 9, 2009 AB RX No No ➤ Subscribe ➤ Subscribe ➤ 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 nateglinide

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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Non-Orange Book US Patents for 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
6,143,323 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 nateglinide

Supplementary Protection Certificates for nateglinide

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

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Serving leading biopharmaceutical companies globally:

McKinsey
Cantor Fitzgerald
Covington
Harvard Business School
Cipla
Johnson and Johnson
Accenture
Fish and Richardson
Teva

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