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Serving leading biopharmaceutical companies globally:

Merck
Covington
Healthtrust
Express Scripts
US Department of Justice
Accenture
Boehringer Ingelheim
Fuji
Novartis
Julphar

Generated: December 12, 2017

DrugPatentWatch Database Preview

JANUVIA Drug Profile

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Which patents cover Januvia, and what generic alternatives are available?

Januvia is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and ninety-six patent family members in forty-seven countries and sixty-eight supplementary protection certificates in fourteen countries.

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

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Merck Sharp DohmeJANUVIAsitagliptin phosphateTABLET;ORAL021995-001Oct 16, 2006RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Merck Sharp DohmeJANUVIAsitagliptin phosphateTABLET;ORAL021995-003Oct 16, 2006RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Merck Sharp DohmeJANUVIAsitagliptin phosphateTABLET;ORAL021995-001Oct 16, 2006RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Merck Sharp DohmeJANUVIAsitagliptin phosphateTABLET;ORAL021995-002Oct 16, 2006RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Merck Sharp DohmeJANUVIAsitagliptin phosphateTABLET;ORAL021995-002Oct 16, 2006RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
Merck Sharp DohmeJANUVIAsitagliptin phosphateTABLET;ORAL021995-003Oct 16, 2006RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Merck Sharp DohmeJANUVIAsitagliptin phosphateTABLET;ORAL021995-002Oct 16, 2006RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Merck Sharp DohmeJANUVIAsitagliptin phosphateTABLET;ORAL021995-002Oct 16, 2006RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Merck Sharp DohmeJANUVIAsitagliptin phosphateTABLET;ORAL021995-003Oct 16, 2006RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Merck Sharp DohmeJANUVIAsitagliptin phosphateTABLET;ORAL021995-003Oct 16, 2006RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Patents for Tradename: JANUVIA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp DohmeJANUVIAsitagliptin phosphateTABLET;ORAL021995-003Oct 16, 2006► Subscribe► Subscribe
Merck Sharp DohmeJANUVIAsitagliptin phosphateTABLET;ORAL021995-001Oct 16, 2006► Subscribe► Subscribe
Merck Sharp DohmeJANUVIAsitagliptin phosphateTABLET;ORAL021995-002Oct 16, 2006► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges 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
8,513,190Method 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
8,318,669Method of regulating glucose metabolism, and reagents related thereto► Subscribe
7,157,429Method of regulating glucose metabolism, and reagents related thereto► Subscribe
7,829,530Method of regulating glucose metabolism, and reagents related thereto► Subscribe
6,803,357 Method of regulating glucose metabolism, and reagents related thereto► Subscribe
8,440,668Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of type 2 diabetes► 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
TaiwanI347185► Subscribe
Morocco27861► Subscribe
Poland367279► Subscribe
Luxembourg92615► Subscribe
South Africa200509933► Subscribe
European Patent Office1625847► Subscribe
South Africa200309294► Subscribe
Peru06542003► Subscribe
Hungary0401104► Subscribe
Luxembourg91470► 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
1084705/02Switzerland► SubscribePRODUCT NAME: VILDAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 57834 30.04.2008
2008013Lithuania► SubscribePRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716
77; 5006-2008Slovakia► SubscribePRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
2014043Lithuania► SubscribePRODUCT NAME: SAXAGLIPTINUM; REGISTRATION NO/DATE: EU/1/09/545/001-015 20091001
/2008Austria► SubscribePRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE ALS MONOPHOSPHAT, UND METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REGISTRATION: CH 58450 01-03 20080408
00707Netherlands► SubscribePRODUCT NAME: SAXAGLIPTIN; REGISTRATION NO/DATE: EU/1/09/545/001-010 20091001
C/GB07/046United Kingdom► SubscribeSUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB07/046 GRANTED TO MERCK SHARP + DOHME CORP. IN RESPECT OF THE PRODUCT SITAGLIPTIN PHOSPHATE MONOHYDRATE, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6212 DATED 11/06/2008 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 22/03/2022.
2014042Lithuania► SubscribePRODUCT NAME: VILDAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/414/001-010, 2007 09 26 EU/1/07/414/018 20070926
2007 00030Denmark► Subscribe
2014045Lithuania► SubscribePRODUCT NAME: ALOGLIPTINUM; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
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Serving leading biopharmaceutical companies globally:

Colorcon
Accenture
Mallinckrodt
Cipla
Julphar
Citi
Dow
Cantor Fitzgerald
Teva
AstraZeneca

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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