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JANUMET Drug Profile

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

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

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

The generic ingredient in JANUMET 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

Patents:4
Applicants:1
NDAs:2
Suppliers / Packagers: see list2
Bulk Api Vendors: see list51
Clinical Trials: see list8
Patent Applications: see list2,611
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 Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme
JANUMET
metformin hydrochloride; sitagliptin phosphate
TABLET;ORAL022044-002Mar 30, 2007RXYesYes6,699,871► SubscribeYY ► Subscribe
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-003Feb 2, 2012RXYesYes6,699,871► SubscribeYY ► 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
metformin hydrochloride; sitagliptin phosphate
TABLET;ORAL022044-001Mar 30, 2007RXYesNo6,699,871► SubscribeYY ► Subscribe
Merck Sharp Dohme
JANUMET
metformin hydrochloride; sitagliptin phosphate
TABLET;ORAL022044-001Mar 30, 2007RXYesNo7,326,708► SubscribeYY ► Subscribe
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Paragraph IV activity 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
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

Country Document Number Estimated Expiration
Denmark1654263► Subscribe
South Africa200509933► Subscribe
Costa Rica7235► Subscribe
Portugal1412357► Subscribe
Argentina044705► 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
0080004 00019Estonia► SubscribePRODUCT NAME: JANUMET - SITAGLIPTIIN / METFORMIINVESINIKKLORIID
0677Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
6 4-2007Slovakia► SubscribePRODUCT NAME: SITAGLIPTIN; NAT. REGISTRATION NO/DATE: EU/1/07/383/001 - EU/1/07/383/018 20070321; FIRST REGISTRATION: EU EU/1/07/383/001 - EU/1/07/383/018
90041-8Sweden► SubscribePRODUCT NAME: SITAGLIPTINFOSFATMONOHYDRAT; REG. NO/DATE: EU/1/07/383/001 20070321
2014000070Germany► SubscribePRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116
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