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JANUVIA Drug Profile

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Januvia is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from six suppliers. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-eight patent family members in forty-four countries.

The generic ingredient in JANUVIA is sitagliptin phosphate. There are twenty-five drug master file entries for this compound. Six suppliers are listed for this compound. There are eight tentative approvals for this compound. Additional details are available on the sitagliptin phosphate profile page.

Summary for Tradename: JANUVIA

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list6
Bulk Api Vendors: see list52
Clinical Trials: see list121
Patent Applications: see list2,611
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:JANUVIA at DailyMed

Pharmacology for Tradename: JANUVIA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-001Oct 16, 2006RXYesNo6,699,871► subscribeYY ► subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-001Oct 16, 2006RXYesNo7,459,428► subscribe ► subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-003Oct 16, 2006RXYesYes7,326,708► subscribeYY ► subscribe
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Paragraph IV activity for: JANUVIA

Drugname Dosage Strength RLD Submissiondate
sitagliptin phosphateTablets25 mg, 50 mg and 100 mgJanuvia10/18/2010

Non-Orange Book Patents for Tradename: JANUVIA

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
7,157,429Method of regulating glucose metabolism, and reagents related thereto► subscribe
8,168,637Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of diabetes► subscribe
9,044,424Methods of regulating glucose metabolism, and reagents related thereto► 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: JANUVIA

Country Document Number Estimated Expiration
European Patent Office1654263► subscribe
Slovenia1654263► subscribe
European Patent Office2574336► 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: JANUVIA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3Finland► subscribe
C/GB08/040United Kingdom► subscribePRODUCT NAME: SITAGLIPTIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE MONOPHOSPHATE, PLUS METFORMIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE HYDROCHLORIDE.; REGISTERED: CH 58450 01-03 20080408; UK EU/1/08/455/001 20080716; UK EU/1/08/455/002 20080716; UK EU/1/08/455/003 20080716; UK EU/1/08/455/004 20080716; UK EU/1/08/455/005 20080716; UK EU/1/08/455/006 20080716; UK EU/1/08/455/007 20080716; UK EU/1/08/455/008 20080716; UK EU/1/08/455/009 20080716; UK EU/1/08/455/010 20080716; UK EU/1/08/455/011 20080716; UK EU/1/08/455/012 20080716; UK EU/1/08/455/013 20080716; UK EU/1/08/455/014 20080716
2007006,C1412357Lithuania► subscribePRODUCT NAME: SITAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/383/001-EU/1/07/383/018 20070321
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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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