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JANUMET Drug Profile

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-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. One supplier is listed for this compound. Additional details are available on the metformin hydrochloride; sitagliptin phosphate profile page.

International Patents:	152
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

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

Identify potential future generic entrants

Case Name	Date
Merck Sharp & Dohme Corp. v. Mylan Pharmaceuticals Inc.	2019-05-02
Merck Sharp & Dohme Corp. v. Sandoz Inc.	2019-02-13
Merck Sharp & Dohme Corp. v. Mylan Pharmaceuticals Inc.	2019-02-13

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

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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	See Pricing	See Pricing	Y			See Pricing
Merck Sharp Dohme	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-003	Feb 2, 2012		RX	Yes	Yes	See Pricing	See Pricing				See Pricing
Merck Sharp Dohme	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-001	Feb 2, 2012		RX	Yes	No	See Pricing	See Pricing	Y	Y		See Pricing
Merck Sharp Dohme	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-003	Feb 2, 2012		RX	Yes	Yes	See Pricing	See Pricing				See Pricing
Merck Sharp Dohme	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-002	Mar 30, 2007		RX	Yes	Yes	See Pricing	See Pricing	Y			See Pricing
Merck Sharp Dohme	JANUMET XR	metformin hydrochloride; sitagliptin phosphate	TABLET, EXTENDED RELEASE;ORAL	202270-002	Feb 2, 2012		RX	Yes	No	See Pricing	See Pricing				See Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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

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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1532149	PA2012022	Lithuania	See Pricing	PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
1261586	1290013-0	Sweden	See Pricing	PRODUCT NAME: SAXAGLIPTIN/METFORMIN; REG. NO/DATE: EU/1/11/731/001 20111124
1412357	C01412357/01	Switzerland	See Pricing	FORMER OWNER: SCHERING CORPORATION, US
1532149	C300569	Netherlands	See Pricing	PRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720
1730131	C01730131/02	Switzerland	See Pricing	PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
1506211	C300677	Netherlands	See Pricing	PRODUCT NAME: COMBINATIE VAN DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN METFORMINE OF EEN FARMACEITISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS BESCHERMD DOOR HET BASISOCTROOI EP 1506211B1; REGISTRATION NO/DATE: EU/1/13/900 20140121
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description