JANUMET Drug Patent Profile

Which patents cover Janumet, and when can generic versions of Janumet launch?

Janumet is a drug marketed by Msd Sub Merck and is included in two NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-one patent family members in forty 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.

DrugPatentWatch^® Generic Entry Outlook for Janumet

Janumet was eligible for patent challenges on October 16, 2010.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 24, 2027. This may change due to patent challenges or generic licensing.

Annual sales in 2021 were $2.1bn, indicating a strong incentive for generic entry (peak sales were $2.6bn in 2020).

There have been twenty-eight 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:	61
US Patents:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	8
Clinical Trials:	20
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
What excipients (inactive ingredients) are in JANUMET?	JANUMET excipients list
DailyMed Link:	JANUMET at DailyMed

See drug prices for JANUMET

See drug sales revenues for JANUMET

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for JANUMET

NDA:

022044

Dosage:

TABLET;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.

Recent Clinical Trials for JANUMET

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Galenicum Health	Phase 1
Eva Pharma	Phase 1
Genuine Research Center, Egypt	Phase 1

See all JANUMET clinical trials

Pharmacology for JANUMET

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

Paragraph IV (Patent) Challenges for JANUMET

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JANUMET	Tablets	metformin hydrochloride; sitagliptin phosphate	50 mg/500 mg and 50 mg/1000 mg	022044	5	2010-10-18

US Patents and Regulatory Information for JANUMET

JANUMET is protected by two US patents and two FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting JANUMET

FDA Regulatory Exclusivity protecting JANUMET

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

Expired US Patents for JANUMET

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

International Patents for JANUMET

See the table below for patents covering JANUMET around the world.

Country	Patent Number	Title	Estimated Expiration
Brazil	PI0411726	composto, monoidrato, sal, composição farmacêutica, método para o tratamento de diabetes tipo 2, processo para preparar o composto, uso do composto, e, processo para a preparação do monoidrato cristalino
Peru	20050696	SAL DIHIDROGENOFOSFATO DE 4-OXO-4-[3-(TRIFLUOROMETIL)-5,6-DIHIDRO[1,2,4]TRIAZOLO[4,3-a]PIRAZIN-7(8H)-IL]-1-(2,4,5-TRIFLUOROFENIL)BUTAN-2-AMINA COMO INHIBIDOR DE LA DIPEPTIDIL PEPTIDASA IV
Dominican Republic	P2002000438	INHIBIDORES DE LA DIPETIDIL PEPTIDASA BETA-AMINO HETEROCÍCLICA PARA EL TRATAMIENTO O LA PREVENCIÓN DE LA DIABETES
Croatia	P20070534
China	1524082
Japan	4463768
Croatia	P20031098	BETA-AMINO TETRAHIDROIMIDAZO (1,2-A) PIRAZINI I TETRAHIDROTRIAZOLO (4,3-A) PIRAZINI KAO INHIBITORI DIPEPTIDIL PEPTIDAZE ZA LIJEČENJE ILI PREVENCIJU DIJABETESA (BETA-AMINO TETRAHYDROIMIDAZO (1,2-A) PYRAZINES AND TETRAHYDROTRIOAZOLO (4,3-A) PYRAZINES AS DIPEPTIDYL PEPTIDASE INHIBITORS FOR THE TREATMENT OR PREVENTION OF DIABETES)

Supplementary Protection Certificates for JANUMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1084705	CR 2014 00065	Denmark		PRODUCT NAME: LINAGLIPTIN; REG. NO/DATE: EU/1/11/707/001-011 20110830
1730131	C01730131/02	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
1084705	SPC/GB14/082	United Kingdom		PRODUCT NAME: SITAGLIPTIN; REGISTERED: UK EU/1/07/383/001-018 20070323; UK EU/1/07/382/001-018 20070323
1412357	91360	Luxembourg		PRODUCT NAME: SITAGLIPTIN; AUTHORISATION NUMBER AND DATE: EU/1/07/383/001-018 20070323
1412357	PA2008013,C1412357	Lithuania		PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
1084705	C300707	Netherlands		PRODUCT NAME: SAXAGLIPTIN; REGISTRATION NO/DATE: EU/1/09/545/001-010 20091001
0896538	91334	Luxembourg		CERTIFICATE TITLE: SITAGLIPTIN, OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE, EN PARTICULIER LE SEL PHOSPHATE (JANUVIA); FIRST REGISTRATION: 20070321