JANUMET XR Drug Patent Profile
✉ Email this page to a colleague
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
Summary for JANUMET XR
International Patents: | 127 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 4 |
Clinical Trials: | 15 |
Patent Applications: | 63 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for JANUMET XR |
Drug Sales Revenues: | Drug sales revenues for JANUMET XR |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for JANUMET XR |
DailyMed Link: | JANUMET XR at DailyMed |


See drug prices 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
Sponsor | Phase |
---|---|
Shahid Beheshti University of Medical Sciences | Phase 1/Phase 2 |
University of Dundee | N/A |
Population Health Research Institute | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for JANUMET XR
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
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 |