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Last Updated: May 27, 2022

JANUMET XR Drug Patent Profile


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

Janumet Xr is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are three patents protecting this drug and two Paragraph IV challenges.

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

The generic ingredient in JANUMET XR 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 Xr

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 $548mm indicating the motivation for generic entry (peak sales were $1.1bn in 2018).

There have been eighteen 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

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Drug patent expirations by year for JANUMET XR
Drug Prices for JANUMET XR

See drug prices for JANUMET XR

Drug Sales Revenue Trends for JANUMET XR

See drug sales revenues for JANUMET XR

DrugPatentWatch® Estimated Generic Entry Opportunity Date for JANUMET XR
Generic Entry Date for JANUMET XR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, EXTENDED RELEASE;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 XR

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

SponsorPhase
Shahid Beheshti University of Medical SciencesPhase 1/Phase 2
University of DundeeN/A
Population Health Research InstitutePhase 3

See all JANUMET XR clinical trials

Paragraph IV (Patent) Challenges for JANUMET XR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
JANUMET XR Extended-release Tablets metformin hydrochloride; sitagliptin phosphate 100 mg/1000 mg 202270 1 2012-10-22
JANUMET XR Extended-release Tablets metformin hydrochloride; sitagliptin phosphate 50 mg/500 mg and 50 mg/1000 mg 202270 1 2012-03-16

US Patents and Regulatory Information for JANUMET XR

JANUMET XR is protected by three US patents and four FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of JANUMET XR is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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 XR

Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting JANUMET XR

ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING
Exclusivity Expiration: See Plans and Pricing

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: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

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 202270-002 Feb 2, 2012 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-001 Feb 2, 2012 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-002 Feb 2, 2012 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-002 Feb 2, 2012 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-003 Feb 2, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-003 Feb 2, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-001 Feb 2, 2012 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 XR

International Patents for JANUMET XR

When does loss-of-exclusivity occur for JANUMET XR?

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

Argentina

Patent: 4705
Estimated Expiration: See Plans and Pricing

Patent: 4185
Estimated Expiration: See Plans and Pricing

Australia

Patent: 04253889
Estimated Expiration: See Plans and Pricing

Austria

Patent: 3003
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0411726
Estimated Expiration: See Plans and Pricing

Canada

Patent: 29400
Estimated Expiration: See Plans and Pricing

China

Patent: 32949
Estimated Expiration: See Plans and Pricing

Patent: 0430397
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 60266
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 17
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0070534
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 06936
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 54263
Estimated Expiration: See Plans and Pricing

Dominican Republic

Patent: 004000941
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 056245
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 9042
Estimated Expiration: See Plans and Pricing

Patent: 0600095
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 54263
Estimated Expiration: See Plans and Pricing

Georgia, Republic of

Patent: 0084489
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2004008938
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 95144
Estimated Expiration: See Plans and Pricing

Iceland

Patent: 92
Estimated Expiration: See Plans and Pricing

Patent: 83
Estimated Expiration: See Plans and Pricing

Israel

Patent: 2563
Estimated Expiration: See Plans and Pricing

Japan

Patent: 63768
Estimated Expiration: See Plans and Pricing

Patent: 06516268
Estimated Expiration: See Plans and Pricing

Jordan

Patent: 25
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 9595
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 05013931
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 405
Estimated Expiration: See Plans and Pricing

Patent: 0208
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 861
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 4026
Estimated Expiration: See Plans and Pricing

Norway

Patent: 5371
Estimated Expiration: See Plans and Pricing

Patent: 060362
Estimated Expiration: See Plans and Pricing

Peru

Patent: 050696
Estimated Expiration: See Plans and Pricing

Poland

Patent: 54263
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 54263
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 873
Estimated Expiration: See Plans and Pricing

Patent: 050947
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 54263
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0509933
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1013431
Estimated Expiration: See Plans and Pricing

Patent: 1016569
Estimated Expiration: See Plans and Pricing

Patent: 060026061
Estimated Expiration: See Plans and Pricing

Patent: 080022232
Estimated Expiration: See Plans and Pricing

Spain

Patent: 91907
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 47185
Estimated Expiration: See Plans and Pricing

Patent: 0524610
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 05329
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 026
Estimated Expiration: See Plans and Pricing

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 XR 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 See Plans and Pricing
Japan 3762407 See Plans and Pricing
Australia 8138698 See Plans and Pricing
Iceland 8183 Fosfórsýru salt af dípeptídýl peptíðasa-IV hindra See Plans and Pricing
Hong Kong 1019204 See Plans and Pricing
Croatia P20070534 See Plans and Pricing
Jordan 2230 مثبطات انزيم داي ببتيديل المحتوي على حلقه غير متجانسه من حلقات البيتا امينو للعلاج او للوقايه من مرض السكري (BETA AMINO HETEROCYCLIC DIPEPTIDYL PEPTIDASE INHIBITORS FOR THE TREATMETN OR PREVENTION OF DIABETES) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for JANUMET XR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1412357 PA2007006,C1412357 Lithuania See Plans and Pricing PRODUCT NAME: SITAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/383/001-EU/1/07/383/018 20070321
1261586 15/2012 Austria See Plans and Pricing 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 See Plans and Pricing 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 See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
1084705 PA2014041 Lithuania See Plans and Pricing PRODUCT NAME: SITAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/383/001-024, 2007 03 21 EU/1/07/382/001-024 20070321
1532149 CA 2013 00001 Denmark See Plans and Pricing PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION ENANTIOMERER OG SALTE DERAF - SAERLIGT LINAGLIPTIN - I KOMBINATION MED METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/12/780/001-028 20120720
>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.