JANUMET Drug Patent Profile

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 four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and thirty-six patent family members in forty-six countries.

The generic ingredient in JANUMET is metformin hydrochloride; sitagliptin phosphate. There are forty-nine drug master file entries for this compound. Three 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 2019 were $1.8bn, indicating a strong incentive for generic entry (peak sales were $2.5bn in 2015).

There have been ten 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.

Indicators of Generic Entry

Summary for JANUMET

International Patents:	136
US Patents:	4
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	15
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

See drug prices for JANUMET

See drug sales revenues for JANUMET

DrugPatentWatch^® Estimated Generic Entry Opportunity 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
Shahid Beheshti University of Medical Sciences	Phase 1/Phase 2
University of Dundee	N/A
Population Health Research Institute	Phase 3

See all JANUMET clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for JANUMET

A10BA	Biguanides
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

A10BH	Dipeptidyl peptidase 4 (DPP-4) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

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 four US patents and four 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
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
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	202270-001	Feb 2, 2012		RX	Yes	No					Y
Merck Sharp Dohme	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
Merck Sharp Dohme	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-001	Mar 30, 2007
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	022044-002	Mar 30, 2007
Merck Sharp Dohme	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-001	Mar 30, 2007
Merck Sharp Dohme	JANUMET	metformin hydrochloride; sitagliptin phosphate	TABLET;ORAL	022044-002	Mar 30, 2007

International Patents for JANUMET

When does loss-of-exclusivity occur for JANUMET?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Austria

Brazil

Canada

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Germany

Hong Kong

Iceland

Israel

Japan

Jordan

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Norway

Peru

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

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

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

Country	Patent Number	Title	Estimated Expiration
Montenegro	P60208	SO FOSFORNE KISJELINE I INHIBITORA DIPEPTIDIL PEPTIDAZE-IV (PHOSPHORIC ACID SALT OF A DIPEPTIDYL PEPTIDASE-IV INHIBITOR)
Canada	2755452	PROCEDE DE REGULATION DU METABOLISME DU GLUCOSE ET REACTIFS AFFERENTS (METHOD OF REGULATING GLUCOSE METABOLISM, AND REAGENTS RELATED THERETO)
Cyprus	1106936
Austria	471148
Hong Kong	1019204

Supplementary Protection Certificates for JANUMET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1412357	PA2007006,C1412357	Lithuania		PRODUCT NAME: SITAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/383/001-EU/1/07/383/018 20070321
1261586	15/2012	Austria		PRODUCT NAME: KOMBINATIONSPRODUKT VON SAXAGLIPTIN UND METFORMIN UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON, BEINHALTEND DIE HYDROCHLORIDSALZE VON SAXAGLIPTIN UND METFORMIN; REGISTRATION NO/DATE: EU/1/11/731/001-EU/1/11/731/012 20111124
1506211	122014000070	Germany		PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, WIE DURCH DAS GRUNDPATENT GESCHUETZT; REGISTRATION NO/DATE: EU/1/13/900 20140116
1261586	132012902044560	Italy		PRODUCT NAME: SAXAGLIPTIN E METFORMINA(KOMBOGLYZE); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/11/731/001 A EU/1/11/731/014, 20111124
1412357	DO 77; 5006-2008	Slovakia		PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716