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Serving 500+ biopharmaceutical companies globally:

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Generated: June 28, 2017

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 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 five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Nateglinide has sixty-three patent family members in thirty-five 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.

Summary for Generic Name: nateglinide

Tradenames:2
Patents:5
Applicants:7
NDAs:7
Drug Master File Entries: see list9
Suppliers / Packagers: see list12
Bulk Api Vendors: see list54
Clinical Trials: see list23
Patent Applications: see list5,552
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:nateglinide at DailyMed

Pharmacology for Ingredient: nateglinide

Drug ClassGlinide
Mechanism of ActionPotassium Channel Antagonists

Tentative approvals for NATEGLINIDE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe60MGTABLET;ORAL
► Subscribe► Subscribe120MGTABLET;ORAL
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;ORAL077467-001Sep 9, 2009DISCNNoNo► Subscribe► Subscribe
Novartis
STARLIX
nateglinide
TABLET;ORAL021204-002Dec 22, 2000ABRXYesYes6,559,188► SubscribeY ► Subscribe
Par Pharm
NATEGLINIDE
nateglinide
TABLET;ORAL077463-001Sep 9, 2009ABRXNoNo► Subscribe► Subscribe
Novartis
STARLIX
nateglinide
TABLET;ORAL021204-001Dec 22, 2000ABRXYesNo6,641,841► SubscribeY ► Subscribe
Novartis
STARLIX
nateglinide
TABLET;ORAL021204-001Dec 22, 2000ABRXYesNo6,559,188► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: nateglinide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
STARLIX
nateglinide
TABLET;ORAL021204-002Dec 22, 20005,488,150► Subscribe
Novartis
STARLIX
nateglinide
TABLET;ORAL021204-002Dec 22, 2000RE34878► Subscribe
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, 20005,463,116► Subscribe
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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
6,143,323 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 Ingredient: nateglinide

Country Document Number Estimated Expiration
New Zealand517280► Subscribe
TaiwanI278312► Subscribe
Portugal965339► Subscribe
ItalyMI20002019► Subscribe
Russian Federation2280447► 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: NATEGLINIDE

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
C0044France► SubscribePRODUCT NAME: NATEGLINIDE; NAT. REGISTRATION NO/DATE: EU/1/01/174/001 20010403; FIRST REGISTRATION: LI - 55401 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
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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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
Novartis
Argus Health
Colorcon
Federal Trade Commission
US Army
Johnson and Johnson
AstraZeneca
Moodys
Baxter

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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