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US Army
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Medtronic
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Accenture
Covington
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Generated: October 20, 2017

DrugPatentWatch Database Preview

JANUVIA Drug Profile

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Which patents cover Januvia, and what generic Januvia 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-five patent family members in forty-six 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.

Summary for Tradename: JANUVIA

US Patents:7
Applicants:1
NDAs:1
Suppliers / Packagers: see list4
Bulk Api Vendors: see list52
Clinical Trials: see list138
Patent Applications: see list2,843
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 TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-003Oct 16, 2006RXYesYes► Subscribe► Subscribe ► Subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-003Oct 16, 2006RXYesYes► Subscribe► Subscribe ► Subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-001Oct 16, 2006RXYesNo► Subscribe► SubscribeYY ► Subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-002Oct 16, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-001Oct 16, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-002Oct 16, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-002Oct 16, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-001Oct 16, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-002Oct 16, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-003Oct 16, 2006RXYesYes► 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 Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-001Oct 16, 2006► Subscribe► Subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-003Oct 16, 2006► Subscribe► Subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;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
7,829,530Method 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
6,803,357 Method of regulating glucose metabolism, and reagents related thereto► Subscribe
7,157,429Method of regulating glucose metabolism, and reagents related thereto► Subscribe
8,318,669Method 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
8,513,190Method 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
South Korea20040010842► Subscribe
Germany122010000020► Subscribe
CroatiaP20031098► Subscribe
Iceland2964► Subscribe
Eurasian Patent Organization200600095► Subscribe
Luxembourg92614► Subscribe
European Patent Office1625847► Subscribe
European Patent Office2226324► Subscribe
Morocco27053► Subscribe
Iceland2218► 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
90041-8Sweden► SubscribePRODUCT NAME: SITAGLIPTINFOSFATMONOHYDRAT; REG. NO/DATE: EU/1/07/383/001 20070321
1084705/04Switzerland► SubscribePRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 61893 08.03.2012
2014 00064Denmark► SubscribePRODUCT NAME: VILDAGLIPTIN; REG. NO/DATE: EU/1/07/414/001-017 20070926
/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
1412357/01Switzerland► SubscribeFORMER OWNER: SCHERING CORPORATION, US
0080004 00019Estonia► SubscribePRODUCT NAME: JANUMET - SITAGLIPTIIN / METFORMIINVESINIKKLORIID
2008013,C1412357Lithuania► SubscribePRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
C/GB14/083United Kingdom► SubscribePRODUCT NAME: ALOGLIPTIN; REGISTERED: UK EU/1/13/844 20130923
00709Netherlands► SubscribePRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
1084705/02Switzerland► SubscribePRODUCT NAME: VILDAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 57834 30.04.2008
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Argus Health
QuintilesIMS
Deloitte
Dow
Baxter
Julphar
Harvard Business School
Johnson and Johnson
Fuji
Covington

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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