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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 patent family members in forty-five countries.

The generic ingredient in JANUMET 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

International Patents:	150
US Patents:	7
Applicants:	1
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	72
Clinical Trials:	12
Patent Applications:	3,147
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JANUMET
DailyMed Link:	JANUMET at DailyMed

Pharmacology for JANUMET

Ingredient-type	Biguanides
Drug Class	Dipeptidyl Peptidase 4 Inhibitor Biguanide
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors

Synonyms for JANUMET

(1R)-3-oxo-3-[3-(trifluoroethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-1-(2,4,5-trifluorobenzyl)propylamine

(2r)-4-oxo-4-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a] pyrazin-7(8h)-yl]-1-(2,4,5-trifluorophenyl)butan-2-amine

(2R)-4-OXO-4-[3-(TRIFLUOROMETHYL)-5,6-DIHYDRO[1,2,4]TRIAZOLO[4,3-A]PYRAZIN-7(8H)-YL]-1-(2,4,5-TRIFLUOROPHENYL)BUTAN-2-AMINE

(2R)-4-oxo-4-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-alpha]pyrazin-7(8H)-yl]-1-(2,4,5-trifluorophenyl)butan-2-amine

(3R)-3-AMINO-1-(3-(TRIFLUOROMETHYL)-5,6,7,8-TETRAHYDRO-1,2,4-TRIAZOLO(4,3-A)PYRAZIN-7-YL)-4-(2,4,5-TRIFLUOROPHENYL)BUTAN-1-ONE

(3R)-3-AMINO-1-[3-(TRIFLUOROMETHYL)-5,6-DIHYDRO[1,2,4]TRIAZOLO[4,3-A]PYRAZIN-7(8H)-YL]-4-(2,4,5-TRIFLUOROPHENYL)-1-BUTANONE

(3R)-3-amino-1-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-4-(2,4,5-trifluorophenyl)butan-1-one

(3R)-3-Amino-1-[3-(trifluoromethyl)-5,6,7,8-tetrahydro-1,2,4-triazolo[4,3-a]pyrazin-7-yl]-4-(2,4,5-trifluorophenyl)butan-1-one

(3R)-3-amino-1-[3-(trifluoromethyl)-5H,6H,7H,8H-[1,2,4]triazolo[3,4-a]pyrazin-7-yl]-4-(2,4,5-trifluorophenyl)butan-1-one hydrochloride

(3R)-3-AMINO-1-[3-(TRIFLUOROMETHYL)-5H,6H,7H,8H-[1,2,4]TRIAZOLO[4,3-A]PYRAZIN-7-YL]-4-(2,4,5-TRIFLUOROPHENYL)BUTAN-1-ONE

(3R)-3-amino-1-[3-(trifluoromethyl)-6,8-dihydro-5H-[1,2,4]triazolo[3,4-c]pyrazin-7-yl]-4-(2,4,5-trifluorophenyl)butan-1-one

(3R)-3-amino-1-[3-(trifluoromethyl)-6,8-dihydro-5H-[1,2,4]triazolo[4,3-a]pyrazin-7-yl]-4-(2,4,5-trifluorophenyl)butan-1-one

(R)-3-AMINO-1-(3-(TRIFLUOROMETHYL)-5,6-DIHYDRO-[1,2,4]TRIAZOLO[4,3-A]PYRAZIN-7(8H)-YL)-4-(2,4,5-TRIFLUOROPHENYL)BUTAN-1-ONE

(R)-4-oxo-4-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]-1-(2,4,5-trifluorophenyl)butan-2-amine

1,2,4-Triazolo(4,3-a)pyrazine, 7-((3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl)-5,6,7,8-tetrahydor-3-(trifluoromethyl)-

1x70

486460-32-6

7-((3R)-3-Amino-1-oxo-4-(2,4,5-trifluorophenyl)buyl)-5,6,7,8-tetrahydro-3-trifluoromethyl)-1,4-triazolo(4,3-a)

7-[(3r)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine

790712-60-6

A25516

AB0006583

AB01563393_01

AB1004599

ABP000233

AC1N9ZYR

ACT02665

AJ-26333

AK172047

AKOS015888724

AMX10120

AN-404

AS-19118

BDBM11162

BRD-K19416115-001-01-2

BSPBio_002262

C16H15F6N5O

CHEBI:40237

CHEMBL1422

CS-2914

D08516

D0P0HH

D0U2JP

DB01261

DTXSID70197572

EC 690-730-1

FT-0650740

FT-0693933

GTPL6286

HMS2093F20

HSDB 7516

HY-13749

Januvia

Januvia (merck & Co.)

Januvia (TN)

KB-60462

LEZ 763

LEZ763

LS-187389

MCULE-2101761133

MFCD09838015

MFFMDFFZMYYVKS-SECBINFHSA-N

MK-0431

MLS006011959

MolPort-003-666-756

NCGC00178734-03

PB17676

PubChem18268

Q-101366

Q-1665

Q-201711

QFP0P1DV7Z

ristaben

RL03803

SBI-0206871.P001

SC-19743

SCHEMBL17783

Sitagliptan

Sitagliptin

Sitagliptin (13)

Sitagliptin (Metformin,MK-0431)

Sitagliptin (Prop.INN)

Sitagliptin [INN:BAN]

sitagliptin monophosphate monohydrate

Sitagliptin phosphate

sitagliptin phosphate anhydrous

Sitagliptin/

Sitagliptin/atovastatin

sitagliptina

sitagliptine

sitagliptinum

SMR002546724

Stotigliptin

Tesavel

Triazolopiperazine Analogue 1

Tube110

UNII-QFP0P1DV7Z

X4663

Xelevia

Z1541638523

ZINC1489478

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

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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

Paragraph IV (Patent) Challenges for JANUMET

Drugname	Dosage	Strength	RLD	Submissiondate
	Extended-release Tablets	100 mg/1000 mg		2012-10-22
	Extended-release Capsules	50 mg/500 mg and 50 mg/1000 mg		2012-03-16
	Tablets	50 mg/500 mg and 50 mg/1000 mg		2010-10-18

Non-Orange Book US Patents for JANUMET

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
7,157,429	Method of regulating glucose metabolism, and reagents related thereto
8,318,669	Method of regulating glucose metabolism, and reagents related thereto
8,513,190	Method of regulating glucose metabolism, and reagents related thereto
8,168,637	Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of diabetes

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International Patents for JANUMET

Country	Document Number	Estimated Expiration
Brazil	PI0210866
China	1524082
Serbia	50737
Japan	5779566

Supplementary Protection Certificates for JANUMET

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2008013	Lithuania		PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REG. NO/DATE: EU/1/08/455/001-014 20080716
2008013,C1412357	Lithuania		PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
2012022	Lithuania		PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
6 4-2007	Slovakia		PRODUCT NAME: SITAGLIPTIN; NAT. REGISTRATION NO/DATE: EU/1/07/383/001 - EU/1/07/383/018 20070321; FIRST REGISTRATION: EU EU/1/07/383/001 - EU/1/07/383/018