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JANUMET Drug Profile

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Janumet is a drug marketed by Merck Sharp Dohme and is included in two NDAs. It is available from three suppliers. 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-six drug master file entries for this compound. Three 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:6
Applicants:1
NDAs:2
Suppliers / Packagers: see list3
Formulation / Manufacturing:see details
Drug Prices: :see details

Pharmacology for Tradename: JANUMET

Clinical Trials for: JANUMET

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme
JANUMET
metformin hydrochloride; sitagliptin phosphate
TABLET;ORAL022044-002Mar 30, 2007RXYes6,699,871Jul 26, 2022YY
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-003Feb 2, 2012RXYes6,699,871Jul 26, 2022YY
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-001Feb 2, 2012RXNo7,125,873Jul 26, 2022Y
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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<disabled in preview>
8,440,668Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of type 2 diabetes<disabled in preview>
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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 Africa200509933<disabled in preview>
Japan5165582<disabled in preview>
China1861077<disabled in preview>
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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
00569Netherlands<disabled>PRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720
C024/2008Ireland<disabled>SPC024/2008: 20090921, EXPIRES: 20230407
90041-8Sweden<disabled>PRODUCT NAME: SITAGLIPTINFOSFATMONOHYDRAT; REG. NO/DATE: EU/1/07/383/001 20070321
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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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