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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 four patents protecting this drug and three Paragraph IV challenges.

This drug has one hundred and thirty-two 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. 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

Janumet was eligible for patent challenges on October 16, 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 seven 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

International Patents:	132
US Patents:	4
Applicants:	1
NDAs:	2
Suppliers / Packagers:	2
Bulk Api Vendors:	75
Clinical Trials:	14
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

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	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-002	Mar 30, 2007		RX	Yes	Yes			Y
Merck Sharp Dohme	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-002	Feb 2, 2012		RX	Yes	No
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	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-002	Mar 30, 2007		RX	Yes	Yes
Merck Sharp Dohme	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-003	Feb 2, 2012		RX	Yes	Yes			Y

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	022044-002	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	022044-002	Mar 30, 2007

International Patents for JANUMET

Country	Patent Number	Estimated Expiration
Yugoslavia	100603
Eurasian Patent Organization	200501805
Portugal	1084705
Canada	2450740
Hungary	225695

Supplementary Protection Certificates for JANUMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1412357	C 2007 091	Romania		PRODUCT NAME: (3R)-3-AMINO-1-[9-(TRIFLUOROMETIL)-1,4,7,8-TETRAZABICICLO[4.3.0]NONA-6,8-DIEN-4-IL]-4-(2,4,5-TRIFLUOROFENIL)BUTAN-1-ONA - SITAGLIPTIN; NATIONAL AUTHORISATION NUMBER: RO EU/1/07/383/001 - RO EU/1/07/383/018; DATE OF NATIONAL AUTHORISATION: 20070321; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/07/383/001 - EU/1/07/383/018; DATE OF FIRST AUTHORISATION IN EEA: 20070321
1084705	PA2014041	Lithuania		PRODUCT NAME: SITAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/383/001-024, 2007 03 21 EU/1/07/382/001-024 20070321
1084705	SPC/GB14/085	United Kingdom		PRODUCT NAME: SAXAGLIPTIN; REGISTERED: UK EU/1/09/545/001-010 20091005
1261586	132012902044560	Italy		PRODUCT NAME: SAXAGLIPTIN E METFORMINA(KOMBOGLYZE); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/11/731/001 A EU/1/11/731/014, 20111124
1506211	42/2014	Austria		PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON UND METFORMIN UND EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES DAVON; REGISTRATION NO/DATE: EU/1/13/900 (MITTEILUNG) 20140121