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JANUMET XR Drug Profile

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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-one patent family members in forty-five countries.

The generic ingredient in JANUMET XR is metformin hydrochloride; sitagliptin phosphate. There are forty-eight 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:	141
US Patents:	6
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Clinical Trials:	12
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JANUMET XR
DailyMed Link:	JANUMET XR at DailyMed

Generic Entry Opportunity Date for JANUMET XR

NDA:

202270

Dosage::

TABLET, EXTENDED RELEASE;ORAL

^*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.

Pharmacology for JANUMET XR

Ingredient-type	Biguanides
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			Y	Y
Merck Sharp Dohme	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-001	Feb 2, 2012		RX	Yes	No
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	202270-002	Feb 2, 2012		RX	Yes	No

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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	202270-003	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

Non-Orange Book US Patents for JANUMET XR

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,829,530	Method of regulating glucose metabolism, and reagents related thereto
8,318,669	Method of regulating glucose metabolism, and reagents related thereto
8,168,637	Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of diabetes
8,513,190	Method of regulating glucose metabolism, and reagents related thereto

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International Patents for JANUMET XR

Country	Document Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	9938501
Serbia	20050947
Canada	2450740
Denmark	1654263

Supplementary Protection Certificates for JANUMET XR

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0080004 00019	Estonia		PRODUCT NAME: JANUMET - SITAGLIPTIIN / METFORMIINVESINIKKLORIID
C0041	France		PRODUCT NAME: SITAGLIPTINE, EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET EN PARTICULIER LE PHOSPHATE DE SITAGLIPTINE MONOHYDRATE; REGISTRATION NO/DATE: EU/1/07/383/001 20070323
2014026,C1506211	Lithuania		PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
00569	Netherlands		PRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720