DrugPatentWatch Database Preview

JANUMET XR Drug Profile

« Back to Dashboard

When do Janumet Xr patents expire, and what generic alternatives are available?

Janumet Xr is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are six patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and forty-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. One supplier is listed for this compound. Additional details are available on the metformin hydrochloride; sitagliptin phosphate profile page.

Summary for JANUMET XR

International Patents:	143
US Patents:	6
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Clinical Trials:	12
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

Pharmacology for JANUMET XR

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

US Patents and Regulatory Information for JANUMET XR

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	202270-002	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	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	202270-002	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			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 XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-003	Feb 2, 2012
Merck Sharp Dohme	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-001	Feb 2, 2012
Merck Sharp Dohme	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-001	Feb 2, 2012
Merck Sharp Dohme	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-002	Feb 2, 2012
Merck Sharp Dohme	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-001	Feb 2, 2012
Merck Sharp Dohme	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-002	Feb 2, 2012

Paragraph IV (Patent) Challenges for JANUMET XR

Drugname	Dosage	Strength	RLD	Date
	Extended-release Tablets	100 mg/1000 mg
	Extended-release Capsules	50 mg/500 mg and 50 mg/1000 mg

International Patents for JANUMET XR

Country	Patent Number	Estimated Expiration
Japan	2006516268
Montenegro	P60208
South Korea	101016569
World Intellectual Property Organization (WIPO)	2005003135
Denmark	1654263
Ukraine	86026

Supplementary Protection Certificates for JANUMET XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1412357	DO 77; 5006-2008	Slovakia		PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
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	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/1/07/383/001-018; DATE OF NATIONAL AUTHORISATION: 20070321; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/07/383/001-018; DATE OF FIRST AUTHORISATION IN EEA: 20070321
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	CA 2008 00035	Denmark		PRODUCT NAME: SITAGLIPTIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER MONOPHOSPHAT, METFORMIN VALGFRIT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT, ISAER HYDROCHLORID
1412357	42/2007	Austria		PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: EU/1/07/383/001-018 (MITTEILUNG) 20070323