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JANUVIA Drug Profile

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Which patents cover Januvia, and what substitute generic drugs are available?

Januvia is a drug marketed by Merck Sharp Dohme and is included in one NDA. 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
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-002Oct 16, 2006RXYesNo6,699,871► SubscribeYY ► Subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-003Oct 16, 2006RXYesYes7,125,873► Subscribe ► 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
6,803,357 Method of regulating glucose metabolism, and reagents related thereto► Subscribe
6,890,898 Method of regulating glucose metabolism, and reagents related thereto► 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
Hungary225695► Subscribe
Japan2014144986► Subscribe
MexicoPA04000018► Subscribe
Portugal1654263► Subscribe
South Korea101016569► 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
2008013,C1412357Lithuania► SubscribePRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
C0035France► SubscribePRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE IN FRANCE: EU/1/07/383/001 DU 20070321; REGISTRATION NO/DATE AT EEC: EU/1/07/383/001-018 DU 20070321
C0041France► SubscribePRODUCT NAME: SITAGLIPTINE, EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET EN PARTICULIER LE PHOSPHATE DE SITAGLIPTINE MONOHYDRATE; REGISTRATION NO/DATE: EU/1/07/383/001 20070323
00357Netherlands► SubscribePRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVA ARDBAAR ZOUT, IN HET BIJZONDER HET MONOFOSFAAT, EN METFORMINE DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
0080004 00019Estonia► SubscribePRODUCT NAME: JANUMET - SITAGLIPTIIN / METFORMIINVESINIKKLORIID
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