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Last Updated: January 20, 2020

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JANUMET Drug Profile

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

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

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

The generic ingredient in JANUMET is metformin hydrochloride; sitagliptin phosphate. There are forty-nine drug master file entries for this compound. One supplier is 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

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Janumet was eligible for patent challenges on October 16th, 2010.

Annual sales in 2017 were $1.5bn, indicating a strong incentive for generic entry (peak sales were $2.5bn in 2015).

There have been four 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.

Drug patent expirations by year for JANUMET
Drug Prices for JANUMET

See drug prices for JANUMET

Drug Sales Revenue Trends for JANUMET

See drug sales revenues for JANUMET

Recent Clinical Trials for JANUMET

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

SponsorPhase
Population Health Research InstitutePhase 3
University Medical Centre LjubljanaPhase 4
Woman'sPhase 4

See all JANUMET clinical trials

Recent Litigation for JANUMET

Identify potential future generic entrants

District Court Litigation
Case NameDate
Merck Sharp & Dohme Corp. v. Mylan Pharmaceuticals Inc.2019-05-02
Merck Sharp & Dohme Corp. v. Anchen Pharmaceuticals, Inc.2019-02-13
Merck Sharp & Dohme Corp. v. Sandoz Inc.2019-02-13

See all JANUMET litigation

PTAB Litigation
PetitionerDate
Mylan Pharmaceuticals, Inc.2019-10-30

See all JANUMET litigation

Pharmacology for JANUMET
Paragraph IV (Patent) Challenges for JANUMET
Tradename Dosage Ingredient NDA Submissiondate
JANUMET TABLET;ORAL metformin hydrochloride; sitagliptin phosphate 022044 2010-10-18

US Patents and Regulatory Information for JANUMET

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 202270-001 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 202270-003 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 202270-001 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   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

Supplementary Protection Certificates for JANUMET

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1506211 CA 2014 00037 Denmark   Start Trial PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
1261586 15/2012 Austria   Start Trial PRODUCT NAME: KOMBINATIONSPRODUKT VON SAXAGLIPTIN UND METFORMIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND DIE HYDROCHLORIDSALZE VON SAXAGLIPTIN UND METFORMIN; REGISTRATION NO/DATE: EU/1/11/731/001-EU/1/11/731/012 20111124
1412357 122008000046 Germany   Start Trial PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE SITAGLIPTINPHOSPHAT- MONOHYDRAT, IN KOMBINATION MIT METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 FIRST REGISTRATION: CH/LI 58450 01 58450 02 58450 03 20080408
1412357 300287 Netherlands   Start Trial 300287, 20220705, EXPIRES: 20220320
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim
AstraZeneca
McKesson
Express Scripts
Harvard Business School

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