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Serving 500+ biopharmaceutical companies globally:

Argus Health
Citi
Johnson and Johnson
Queensland Health
Medtronic
UBS
Cipla
Cerilliant
Moodys
McKesson

Generated: June 23, 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 one hundred and ninety-one patent family members in forty-six 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. Additional details are available on the metformin hydrochloride; sitagliptin phosphate profile page.

Summary for Tradename: JANUMET

Patents:8
Applicants:1
NDAs:2
Suppliers / Packagers: see list2
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, 2012RXYesNo7,459,428► Subscribe ► Subscribe
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-003Feb 2, 2012RXYesYes7,459,428► Subscribe ► Subscribe
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-001Feb 2, 2012RXYesNo7,326,708► SubscribeYY ► Subscribe
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-002Feb 2, 2012RXYesNo7,125,873► SubscribeY ► Subscribe
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-003Feb 2, 2012RXYesYes6,890,898► Subscribe ► 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, 20076,303,661► Subscribe
Merck Sharp Dohme
JANUMET
metformin hydrochloride; sitagliptin phosphate
TABLET;ORAL022044-001Mar 30, 20076,303,661► 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
7,157,429Method of regulating glucose metabolism, and reagents related thereto► Subscribe
8,318,669Method of regulating glucose metabolism, and reagents related thereto► Subscribe
8,513,190Method of regulating glucose metabolism, and reagents related thereto► Subscribe
8,168,637Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of diabetes► Subscribe
7,829,530Method 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
Japan2010248253► Subscribe
Japan2013047260► Subscribe
Jordan2230► Subscribe
Jordan2625► Subscribe
Dominican RepublicP2004000941► 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
2014 00062Denmark► SubscribePRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SAXAGLIPTIN HYDROCHLORID; REG. NO/DATE: EU/1/09/545/001-015 20091001
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
C0041France► SubscribePRODUCT NAME: SITAGLIPTINE, EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET EN PARTICULIER LE PHOSPHATE DE SITAGLIPTINE MONOHYDRATE; REGISTRATION NO/DATE: EU/1/07/383/001 20070323
2014 00065Denmark► SubscribePRODUCT NAME: LINAGLIPTIN; REG. NO/DATE: EU/1/11/707/001-011 20110824
2013 00001Denmark► SubscribePRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION ENANTIOMERER OG SALTE DERAF - SAERLIGT LINAGLIPTIN - I KOMBINATION MED METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/12/780/001-028 20120720
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Novartis
Fish and Richardson
Express Scripts
McKesson
Citi
Medtronic
Deloitte
Queensland Health
Mallinckrodt
UBS

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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