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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

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

Summary for JANUMET

International Patents:	153
US Patents:	7
Applicants:	1
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	75
Clinical Trials:	12
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
DailyMed Link:	JANUMET at DailyMed

See drug prices for JANUMET

See drug sales revenues for JANUMET

Recent Clinical Trials for JANUMET

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

Sponsor	Phase
Population Health Research Institute	Phase 3
University Medical Centre Ljubljana	Phase 4
Woman's	Phase 4

See all JANUMET clinical trials

Recent Litigation for JANUMET

Identify potential future generic entrants

District Court Litigation

Case Name	Date
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

Petitioner	Date
Mylan Pharmaceuticals, Inc.	2019-10-30

See all JANUMET litigation

Pharmacology for JANUMET

Drug Class	Dipeptidyl Peptidase 4 Inhibitor Biguanide
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors

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			Y
Merck Sharp Dohme	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-003	Feb 2, 2012		RX	Yes	Yes
Merck Sharp Dohme	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-001	Feb 2, 2012		RX	Yes	No			Y	Y
Merck Sharp Dohme	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-003	Feb 2, 2012		RX	Yes	Yes

Expired US Patents for JANUMET

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-002	Mar 30, 2007
Merck Sharp Dohme	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-001	Mar 30, 2007
Merck Sharp Dohme	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-001	Mar 30, 2007
Merck Sharp Dohme	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-001	Mar 30, 2007

International Patents for JANUMET

Country	Patent Number	Estimated Expiration
Japan	4463768
Peru	20050696
European Patent Office	1520582
Portugal	1654263

Supplementary Protection Certificates for JANUMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1506211	CA 2014 00037	Denmark		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		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		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		300287, 20220705, EXPIRES: 20220320