JANUMET Drug Patent Profile

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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

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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
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
What excipients (inactive ingredients) are in JANUMET?	JANUMET excipients list
DailyMed Link:	JANUMET at DailyMed

Drug patent expirations by year for JANUMET

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

Generic Entry Date for JANUMET^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
Genuine Research Center, Egypt	Phase 1
Eva Pharma	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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of JANUMET is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
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

Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Pharmaceutical compositions of combinations of dipeptidyl peptidase-4 inhibitors with metformin
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

FDA Regulatory Exclusivity protecting JANUMET

ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING
Exclusivity Expiration: ⤷ Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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

Expired US Patents for JANUMET

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

International Patents for JANUMET

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

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Country	Patent Number	Title	Estimated Expiration
Tunisia	SN05329	PHOSPHORIC ACID SALT OF A DIPEPTIDYL PEPTIDASE -IV INHIBITOR	⤷ Sign Up
Canada	2252576	UTILISATION D'INHIBITEURS DE LA DIPEPTIDYL-PEPTIDASE DE TYPEIV POUR ABAISSER LE NIVEAU DE GLUCOSE DANS LE SANG DES MAMMIFERES (USE OF DIPEPTIDYL PEPTIDASE IV INHIBITORS FOR LOWERING THE BLOOD GLUCOSE LEVEL IN MAMMALS)	⤷ Sign Up
New Zealand	544026	Phosphoric acid salt of 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	⤷ Sign Up
European Patent Office	1084705	Méthode pour diminuer le taux de glucose sanguin des mammifères (Method for lowering blood glucose levels in mammals)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	9740832		⤷ Sign Up
Germany	04029691		⤷ Sign Up
Australia	2493599		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for JANUMET

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1412357	CA 2008 00035	Denmark	⤷ Sign Up	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	DO 77; 5006-2008	Slovakia	⤷ Sign Up	PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
1084705	C01084705/05	Switzerland	⤷ Sign Up	PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 62955 21.11.2013
1084705	C01084705/02	Switzerland	⤷ Sign Up	PRODUCT NAME: VILDAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 57834 30.04.2008
0896538	91334	Luxembourg	⤷ Sign Up	CERTIFICATE TITLE: SITAGLIPTIN, OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE, EN PARTICULIER LE SEL PHOSPHATE (JANUVIA); FIRST REGISTRATION: 20070321
1412357	PA2008013,C1412357	Lithuania	⤷ Sign Up	PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716
1412357	C20080004 00019	Estonia	⤷ Sign Up	PRODUCT NAME: JANUMET - SITAGLIPTIIN / METFORMIINVESINIKKLORIID
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description