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JANUMET XR Drug Profile
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» See Plans and PricingWhich 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
Summary for JANUMET XR
| International Patents: | 123 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 14 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for JANUMET XR |
| Drug Sales Revenues: | Drug sales revenues for JANUMET XR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for JANUMET XR |
| DailyMed Link: | JANUMET XR at DailyMed |
See drug prices for JANUMET XR
Recent Clinical Trials for JANUMET XR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Shahid Beheshti University of Medical Sciences | Phase 1/Phase 2 |
| University of Dundee | N/A |
| Population Health Research Institute | Phase 3 |
Recent Litigation for JANUMET XR
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| In re: Sitagliptin Phosphate ('708 & '921) Patent Litigation | 2019-08-08 |
| Merck Sharp & Dohme Corp. v. Mylan Pharmaceuticals Inc. | 2019-05-02 |
| Merck Sharp & Dohme Corp. v. Torrent Pharmaceuticals Limited | 2019-02-13 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Mylan Pharmaceuticals, Inc. | 2019-10-30 |
| 2014-04-17 | |
| 2014-01-24 |
Pharmacology for JANUMET XR
| Drug Class | Dipeptidyl Peptidase 4 Inhibitor Biguanide |
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
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
Expired US Patents for JANUMET XR
International Patents for JANUMET XR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Iceland | 2964 | Start Trial |
| Spain | 2158562 | Start Trial |
| Japan | 2001510442 | Start Trial |
| Cyprus | 1106936 | Start Trial |
| South Korea | 20050104428 | Start Trial |
| Germany | 122007000056 | Start Trial |
| Netherlands | 300357 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
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 |
