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Serving leading biopharmaceutical companies globally:

Harvard Business School
Deloitte
UBS
Baxter
Chubb
Accenture
US Army
US Department of Justice
Johnson and Johnson
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Generated: October 20, 2017

DrugPatentWatch Database Preview

JANUMET Drug Profile

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Which patents cover Janumet, and when can generic versions of Janumet launch?

Janumet is a drug marketed by Merck Sharp Dohme and is included in two NDAs. There are ten patents protecting this drug and three Paragraph IV challenges.

This drug has two hundred and four patent family members in forty-six countries and eighty-eight supplementary protection certificates in fourteen countries.

The generic ingredient in JANUMET is metformin hydrochloride; sitagliptin phosphate. There are forty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the metformin hydrochloride; sitagliptin phosphate profile page.

Summary for Tradename: JANUMET

US Patents:8
Applicants:1
NDAs:2
Suppliers / Packagers: see list1
Bulk Api Vendors: see list51
Clinical Trials: see list12
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:JANUMET at DailyMed

Pharmacology for Tradename: JANUMET

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
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-001Feb 2, 2012RXYesNo► Subscribe► SubscribeYY ► Subscribe
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-003Feb 2, 2012RXYesYes► Subscribe► SubscribeYY ► Subscribe
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-001Feb 2, 2012RXYesNo► Subscribe► Subscribe ► Subscribe
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-002Feb 2, 2012RXYesNo► Subscribe► SubscribeY ► Subscribe
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-003Feb 2, 2012RXYesYes► Subscribe► Subscribe ► Subscribe
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-002Feb 2, 2012RXYesNo► Subscribe► SubscribeY ► Subscribe
Merck Sharp Dohme
JANUMET
metformin hydrochloride; sitagliptin phosphate
TABLET;ORAL022044-002Mar 30, 2007RXYesYes► Subscribe► SubscribeYY ► Subscribe
Merck Sharp Dohme
JANUMET
metformin hydrochloride; sitagliptin phosphate
TABLET;ORAL022044-001Mar 30, 2007RXYesNo► Subscribe► Subscribe ► Subscribe
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-002Feb 2, 2012RXYesNo► Subscribe► Subscribe ► Subscribe
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-001Feb 2, 2012RXYesNo► Subscribe► SubscribeYY ► Subscribe
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Expired Patents for Tradename: JANUMET

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
JANUMET
metformin hydrochloride; sitagliptin phosphate
TABLET;ORAL022044-002Mar 30, 2007► Subscribe► Subscribe
Merck Sharp Dohme
JANUMET
metformin hydrochloride; sitagliptin phosphate
TABLET;ORAL022044-001Mar 30, 2007► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges for JANUMET

Drugname Dosage Strength RLD Submissiondate
sitagliptin phosphate and metformin hydrochlorideExtended-release Tablets100 mg/1000 mgJanumet XR10/22/2012
sitagliptin phosphate and metformin hydrochlorideExtended-release Capsules50 mg/500 mg and 50 mg/1000 mgJanumet XR3/16/2012
sitagliptin phosphate and metformin hydrochlorideTablets50 mg/500 mg and 50 mg/1000 mgJanumet10/18/2010

Non-Orange Book Patents for Tradename: JANUMET

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: JANUMET

Country Document Number Estimated Expiration
South Korea20040010842► Subscribe
Germany122010000020► Subscribe
CroatiaP20031098► Subscribe
China101365432► Subscribe
Iceland2964► Subscribe
Eurasian Patent Organization200600095► Subscribe
Japan5165582► Subscribe
Luxembourg92614► Subscribe
European Patent Office1625847► Subscribe
European Patent Office2226324► 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: JANUMET

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
00708Netherlands► SubscribePRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001-011 20111224
2007 00030Denmark► Subscribe
2014 00065Denmark► SubscribePRODUCT NAME: LINAGLIPTIN; REG. NO/DATE: EU/1/11/707/001-011 20110824
/2007Austria► SubscribePRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: EU/1/07/383/001-018 (MITTEILUNG) 20070323
C024/2008Ireland► SubscribeSPC024/2008: 20090921, EXPIRES: 20230407
2008013Lithuania► SubscribePRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716
C/GB14/085United Kingdom► SubscribePRODUCT NAME: SAXAGLIPTIN; REGISTERED: UK EU/1/09/545/001-010 20091005
2008000046Germany► SubscribePRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE SITAGLIPTINPHOSPHAT- MONOHYDRAT, IN KOMBINATION MIT METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 FIRST REGISTRATION: CH/LI 58450 01 58450 02 58450 03 20080408
0287Netherlands► Subscribe300287, 20220705, EXPIRES: 20220320
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Boehringer Ingelheim
Fish and Richardson
Chinese Patent Office
Novartis
Johnson and Johnson
McKesson
Accenture
Chubb
Citi

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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