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Last Updated: June 2, 2020

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JANUMET XR Drug Profile


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Which patents cover Janumet Xr, and when can generic versions of Janumet Xr launch?

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

This drug has one hundred and twenty-three patent family members in forty-five countries.

The generic ingredient in JANUMET XR is metformin hydrochloride; sitagliptin phosphate. There are forty-nine 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.

US ANDA Litigation and Generic Entry Outlook for Janumet Xr

Annual sales in 2017 were $853mm indicating the motivation for generic entry.

There have been fourteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (metformin hydrochloride; sitagliptin phosphate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for JANUMET XR
Drug Prices for JANUMET XR

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Drug Sales Revenue Trends for JANUMET XR

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Recent Clinical Trials for JANUMET XR

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Shahid Beheshti University of Medical SciencesPhase 1/Phase 2
University of DundeeN/A
Population Health Research InstitutePhase 3

See all JANUMET XR clinical trials

Recent Litigation for JANUMET XR

Identify potential future generic entrants

District Court Litigation
Case NameDate
In re: Sitagliptin Phosphate ('708 & '921) Patent Litigation2019-08-08
Merck Sharp & Dohme Corp. v. Mylan Pharmaceuticals Inc.2019-05-02
Merck Sharp & Dohme Corp. v. Torrent Pharmaceuticals Limited2019-02-13

See all JANUMET XR litigation

PTAB Litigation
PetitionerDate
Mylan Pharmaceuticals, Inc.2019-10-30
2014-04-17
2014-01-24

See all JANUMET XR litigation

Pharmacology for JANUMET XR
Paragraph IV (Patent) Challenges for JANUMET XR
Tradename Dosage Ingredient NDA Submissiondate
JANUMET XR TABLET, EXTENDED RELEASE;ORAL metformin hydrochloride; sitagliptin phosphate 202270 2012-10-22
JANUMET XR TABLET, EXTENDED RELEASE;ORAL metformin hydrochloride; sitagliptin phosphate 202270 2012-03-16

US Patents and Regulatory Information for JANUMET XR

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;ORAL 202270-002 Feb 2, 2012 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-003 Feb 2, 2012 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-002 Feb 2, 2012 RX Yes No   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-001 Feb 2, 2012 RX Yes No   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-003 Feb 2, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-002 Feb 2, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-002 Feb 2, 2012 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for JANUMET XR

Supplementary Protection Certificates for JANUMET XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1532149 CA 2013 00001 Denmark   Start Trial PRODUCT 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
1506211 92496 Luxembourg   Start Trial PRODUCT NAME: COMBINAISON DE DAPAGLIFLOZINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DE METFORMINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,TELLE QUE PROTEGEE PAR LE BREVET DE BASE EP1506211 B1
0896538 CA 2007 00061 Denmark   Start Trial
1412357 PA2008013,C1412357 Lithuania   Start Trial PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
1412357 SPC024/2008 Ireland   Start Trial SPC024/2008: 20090921, EXPIRES: 20230407
1412357 2007/029 Ireland   Start Trial PRODUCT NAME: SITAGLIPTIN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
0896538 08C0008 France   Start Trial PRODUCT NAME: VILDAGLIPTINE OU UN DE SES SELS PHARMACETIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/07/414/001 DU 20070926; REGISTRATION NO/DATE AT EEC: EU/1/07/414/001-017 DU 20070926
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
McKesson
Medtronic
Moodys
Johnson and Johnson
Harvard Business School

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