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Janumet is a drug marketed by Merck Sharp Dohme and is included in two NDAs. There are four patents protecting this drug and three Paragraph IV challenges.
This drug has one hundred and thirty-six patent family members in forty-six countries.
The generic ingredient in JANUMET is metformin hydrochloride; sitagliptin phosphate. There are forty-nine 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.
Janumet was eligible for patent challenges on October 16, 2010.
By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 24, 2027. This may change due to patent challenges or generic licensing.
Annual sales in 2018 were $1.6bn, indicating a strong incentive for generic entry (peak sales were $2.5bn in 2015).
There have been nine 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
|Suppliers / Packagers:||2|
|Bulk Api Vendors:||75|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price information for JANUMET|
|Drug Sales Revenues:||Drug sales revenues for JANUMET|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for JANUMET|
|What excipients (inactive ingredients) are in JANUMET?||JANUMET excipients list|
|DailyMed Link:||JANUMET at DailyMed|
Generic Entry Opportunity Date for JANUMET
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for JANUMET
Identify potential brand extensions & 505(b)(2) entrants
|Shahid Beheshti University of Medical Sciences||Phase 1/Phase 2|
|University of Dundee||N/A|
|Population Health Research Institute||Phase 3|
|Country||Patent Number||Estimated Expiration|
|South Korea||101016569||Start Trial|
|New Zealand||529833||Start Trial|
|European Patent Office||1084705||Start Trial|
|>Country||>Patent Number||>Estimated Expiration|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|1084705||CA 2014 00066||Denmark||Start Trial||PRODUCT NAME: ALOGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER ALOGLIPTIN BENZOATE; REG. NO/DATE: EU/1/13/844/001-027 20130919|
|1412357||DO 77; 5006-2008||Slovakia||Start Trial||PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716|
|1084705||PA2014042||Lithuania||Start Trial||PRODUCT NAME: VILDAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/414/001-010, 2007 09 26 EU/1/07/414/018 20070926|
|1412357||300287||Netherlands||Start Trial||PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER SITAGLIPTINE FOSFAAT MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070323|
|2498758||122020000018||Germany||Start Trial||PRODUCT NAME: METFORMIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; SAXAGLIPTIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; DAPAGLIFLOZIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1401 20191111|
|1412357||PA2007006,C1412357||Lithuania||Start Trial||PRODUCT NAME: SITAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/383/001-EU/1/07/383/018 20070321|
|1084705||CA 2014 00062||Denmark||Start Trial||PRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SAXAGLIPTIN HYDROCHLORID; REG. NO/DATE: EU/1/09/545/001-015 20091001|
|>Patent Number||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration||>SPC Description|