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JANUMET XR Drug Profile

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

Janumet Xr is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are five patents protecting this drug and two Paragraph IV challenges.

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

The generic ingredient in JANUMET XR is metformin hydrochloride; sitagliptin phosphate. There are forty-seven drug master file entries for this compound. Two suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the metformin hydrochloride; sitagliptin phosphate profile page.

Summary for Tradename: JANUMET XR

Patents:5
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Clinical Trials: see list4
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:JANUMET XR at DailyMed

Pharmacology for Tradename: JANUMET XR

Applicant Tradename Generic Name Dosage NDA Approval Date 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;ORAL202270-002Feb 2, 2012RXYesNo6,699,871► SubscribeYY ► Subscribe
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-003Feb 2, 2012RXYesYes7,125,873► SubscribeY ► Subscribe
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-002Feb 2, 2012RXYesNo6,340,475► SubscribeY ► Subscribe
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-001Feb 2, 2012RXYesNo7,125,873► SubscribeY ► Subscribe
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-003Feb 2, 2012RXYesYes7,326,708► SubscribeYY ► Subscribe
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Expired Patents for Tradename: JANUMET XR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-003Feb 2, 20126,635,280► Subscribe
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-002Feb 2, 20126,340,475► Subscribe
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-001Feb 2, 20126,340,475► Subscribe
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-003Feb 2, 20126,340,475► Subscribe
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-001Feb 2, 20126,635,280► Subscribe
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Paragraph IV activity for: JANUMET XR

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

Non-Orange Book Patents for Tradename: JANUMET XR

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
8,168,637Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of diabetes► 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: JANUMET XR

Country Document Number Estimated Expiration
Spain2248908► Subscribe
BrazilPI0411726► Subscribe
Portugal998271► Subscribe
Hong Kong1095144► Subscribe
Iceland7062► 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 XR

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
2014 00037Denmark► SubscribePRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
07/029Ireland► SubscribePRODUCT NAME: SITAGLIPTIN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
2012022Lithuania► SubscribePRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
C024/2008Ireland► SubscribeSPC024/2008: 20090921, EXPIRES: 20230407
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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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