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Last Updated: June 8, 2023

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 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 twenty-seven 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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Drug patent expirations by year for JANUMET
Drug Prices for JANUMET

See drug prices for JANUMET

Drug Sales Revenue Trends for JANUMET

See drug sales revenues for JANUMET

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for JANUMET
Generic Entry Date for JANUMET*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Genuine Research Center, EgyptPhase 1
Eva PharmaPhase 1
Shahid Beheshti University of Medical SciencesPhase 1/Phase 2

See all JANUMET clinical trials

Pharmacology for JANUMET
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.

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

This potential generic entry date is based on patent ⤷  Try a Trial.

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

Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Beta-amino tetrahydroimidazo (1, 2-a) pyrazines and tetrahydrotrioazolo (4, 3-a) pyrazines as dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Pharmaceutical compositions of combinations of dipeptidyl peptidase-4 inhibitors with metformin
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting JANUMET

ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING
Exclusivity Expiration: ⤷  Try a Trial

INFORMATION ADDED TO THE LABELING REGARDING EFFICACY AND SAFETY OF THE CONTINUATION OF SITAGLIPTIN COMPARED WITH THE WITHDRAWAL OF SITAGLIPTIN DURING INITIATION AND TITRATION OF INSULIN GLARGINE IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS
Exclusivity Expiration: ⤷  Try a Trial

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Try a Trial

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-003 Feb 2, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-001 Feb 2, 2012 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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

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

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

Patent: 4705
Estimated Expiration: ⤷  Try a Trial

Patent: 4185
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 04253889
Estimated Expiration: ⤷  Try a Trial

Austria

Patent: 3003
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0411726
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 29400
Estimated Expiration: ⤷  Try a Trial

China

Patent: 32949
Estimated Expiration: ⤷  Try a Trial

Patent: 0430397
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 60266
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 17
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0070534
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 06936
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 54263
Estimated Expiration: ⤷  Try a Trial

Dominican Republic

Patent: 004000941
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 056245
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 9042
Estimated Expiration: ⤷  Try a Trial

Patent: 0600095
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 54263
Estimated Expiration: ⤷  Try a Trial

Georgia, Republic of

Patent: 0084489
Estimated Expiration: ⤷  Try a Trial

Germany

Patent: 2004008938
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 95144
Estimated Expiration: ⤷  Try a Trial

Iceland

Patent: 92
Estimated Expiration: ⤷  Try a Trial

Patent: 83
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 2563
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 63768
Estimated Expiration: ⤷  Try a Trial

Patent: 06516268
Estimated Expiration: ⤷  Try a Trial

Jordan

Patent: 25
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 9595
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 05013931
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 405
Estimated Expiration: ⤷  Try a Trial

Patent: 0208
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 861
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 4026
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 5371
Estimated Expiration: ⤷  Try a Trial

Patent: 060362
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 050696
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 54263
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 54263
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 873
Estimated Expiration: ⤷  Try a Trial

Patent: 050947
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 54263
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0509933
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1013431
Estimated Expiration: ⤷  Try a Trial

Patent: 1016569
Estimated Expiration: ⤷  Try a Trial

Patent: 060026061
Estimated Expiration: ⤷  Try a Trial

Patent: 080022232
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 91907
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 47185
Estimated Expiration: ⤷  Try a Trial

Patent: 0524610
Estimated Expiration: ⤷  Try a Trial

Tunisia

Patent: 05329
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 026
Estimated Expiration: ⤷  Try a Trial

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
Taiwan 200524610 Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor ⤷  Try a Trial
Slovenia 1412357 ⤷  Try a Trial
Eurasian Patent Organization 200501805 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for JANUMET

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1412357 C 2007 091 Romania ⤷  Try a Trial PRODUCT NAME: (3R)-3-AMINO-1-[9-(TRIFLUOROMETIL)-1,4,7,8-TETRAZABICICLO[4.3.0]NONA-6,8-DIEN-4-IL]-4-(2,4,5-TRIFLUOROFENIL)BUTAN-1-ONA - SITAGLIPTIN; NATIONAL AUTHORISATION NUMBER: RO EU/1/07/383/001 - RO EU/1/07/383/018; DATE OF NATIONAL AUTHORISATION: 20070321; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/07/383/001 - EU/1/07/383/018; DATE OF FIRST AUTHORISATION IN EEA: 20070321
1084705 PA2014041 Lithuania ⤷  Try a Trial PRODUCT NAME: SITAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/383/001-024, 2007 03 21 EU/1/07/382/001-024 20070321
1084705 SPC/GB14/085 United Kingdom ⤷  Try a Trial PRODUCT NAME: SAXAGLIPTIN; REGISTERED: UK EU/1/09/545/001-010 20091005
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.