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Profile for Tradename: JANUMET

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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 ten patents protecting this drug and three Paragraph IV challenges.

This drug has one hundred and seventy-seven patent family members in forty-six 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:10
Applicants:1
NDAs:2
Suppliers / Packagers: see list15
Formulation / Manufacturing:see details
2013 Sales:$987,663,000

Pharmacology for Tradename: JANUMET

Clinical Trials for: JANUMET

JanUmet Before Insulin Lantus In Eastern Population Evaluation Program (JUBILEE) In Type 2 Diabetic Patients
Status: Not yet recruiting Condition: Type 2 Diabetes Mellitus

Sitagliptin/Metformin (JANUMET) Re-examination Study (0431A-182)
Status: Completed Condition: Type 2 Diabetes Mellitus

Sitagliptin Therapy in Hospitalized Patients With Type 2 Diabetes
Status: Recruiting Condition: Type 2 Diabetes

A Post Marketing Safety Study of Sitagliptin Phosphate/Metformin Hydrochloride (JANUMET®) (MK-0431A-235)
Status: Terminated Condition: Diabetes Mellitus, Type 2

Metformin and Sitagliptin Therapy for Adult Patients With Type 2 Diabetes Admitted to the General Medical Unit
Status: Not yet recruiting Condition: Type 2 Diabetes Mellitus

A Pilot Study to Assess the Glucose Lowering Effect of Metformin and Sitagliptin in Adolescents With Type 1 Diabetes
Status: Recruiting Condition: Type 1 Diabetes

Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination (FDC) Compared to Glimepiride in Participants With Type 2 Diabetes Mellitus (MK-0431A-202)
Status: Completed Condition: Type 2 Diabetes Mellitus

A Double-Blind, Randomized, Active-Comparator (Metformin) Controlled, Clinical Trial to Study the Efficacy and Safety of the Strategy to Start Patients With Type 2 Diabetes Mellitus on Janumet™ Compared to Metformin
Status: Recruiting Condition: Diabetes Type 2

A Study to Assess the Efficacy and Safety of ASP1941 in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and Sitagliptin
Status: Not yet recruiting Condition: Type 2 Diabetes Mellitus

A Study to Evaluate the Efficacy and Safety of the Addition of Canagliflozin in Participants With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin and Sitagliptin
Status: Recruiting Condition: Diabetes Mellitus, Type 2

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-003Feb 2, 2012RXYes7,078,381<disabled><disabled>
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-002Feb 2, 2012RXNo7,078,381<disabled><disabled>
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-001Feb 2, 2012RXNo6,890,898<disabled><disabled>
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-003Feb 2, 2012RXYes6,635,280<disabled>Y<disabled>
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-001Feb 2, 2012RXNo7,078,381<disabled><disabled>
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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
8,318,669Method of regulating glucose metabolism, and reagents related thereto<disabled in preview>
7,829,530Method of regulating glucose metabolism, and reagents related thereto<disabled in preview>
8,168,637Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of diabetes<disabled in preview>
8,513,190Method of regulating glucose metabolism, and reagents related thereto<disabled in preview>
7,157,429Method of regulating glucose metabolism, and reagents related thereto<disabled in preview>
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International Patent Family for Tradename: JANUMET

Country Document Number Publication Date
South Korea20040010842Jan 31, 2004
New Zealand332707Oct 28, 1999
Japan2013047260Mar 07, 2013
Japan2001510442Jul 31, 2001
Germany04029691Nov 08, 2007
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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