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
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: | 16 |
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 |



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
Sponsor | Phase |
---|---|
Genuine Research Center, Egypt | Phase 1 |
Eva Pharma | Phase 1 |
Shahid Beheshti University of Medical Sciences | Phase 1/Phase 2 |
Pharmacology for JANUMET
Drug Class | Biguanide Dipeptidyl Peptidase 4 Inhibitor |
Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes 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 |