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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.

The generic ingredient in JANUMET is metformin hydrochloride; sitagliptin phosphate. There are fourty-six drug master file entries for this compound. Three suppliers are listed 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: see list3
2013 Sales:$987,663,000

Pharmacology for Tradename: JANUMET

Clinical Trials for: JANUMET

Glossary
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;ORAL202270Feb 2, 2012RXNo6,699,871<disabled>YY<disabled>
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270Feb 2, 2012RXNo6,635,280<disabled>Y<disabled>
Merck Sharp Dohme
JANUMET
metformin hydrochloride; sitagliptin phosphate
TABLET;ORAL022044Mar 30, 2007RXNo7,078,381<disabled><disabled>
Merck Sharp Dohme
JANUMET
metformin hydrochloride; sitagliptin phosphate
TABLET;ORAL022044Mar 30, 2007RXNo6,303,661<disabled><disabled>
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270Feb 2, 2012RXYes6,890,898<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
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Preferred citation:

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

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