Janumet Drug Patent Profile
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Which patents cover Janumet, and what generic alternatives are available?
Janumet is a drug marketed by Msd Sub Merck and is included in two NDAs. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has sixty-one patent family members in forty countries.
The generic ingredient in JANUMET is metformin hydrochloride; sitagliptin phosphate. There are forty-nine drug master file entries for this compound. Two 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 2021 were $2.1bn, indicating a strong incentive for generic entry (peak sales were $2.6bn in 2020).
There have been twenty-eight 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: | 61 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 8 |
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 two US patents and two 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
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
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Try a Trial
Expired US Patents for Janumet
International Patents for Janumet
See the table below for patents covering Janumet around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
World Intellectual Property Organization (WIPO) | 9740832 | ⤷ Try a Trial | |
Luxembourg | 92613 | ⤷ Try a Trial | |
Japan | 2014144986 | METHODS OF REGULATING GLUCOSE METABOLISM, AND REAGENTS RELATED THERETO | ⤷ Try a Trial |
Bulgaria | 108493 | ⤷ Try a Trial | |
European Patent Office | 2289513 | ⤷ Try a Trial | |
European Patent Office | 1412357 | BETA-AMINO-TETRAHYDROIMIDAZO(1, 2-A)PYRAZINES ET BETA-AMINO-TETRAHYDROTRIOAZOLO(4, 3-A)PYRAZINES UTILISEES EN TANT QU'INHIBITEURS DE LA DIPEPTIDYL PEPTIDASE DANS LE TRAITEMENT OU LA PREVENTION DU DIABETE (BETA-AMINO TETRAHYDROIMIDAZO(1,2-A)PYRAZINES AND TETRAHYDROTRIAZOLO(4,3-A)PYRAZINES AS DIPEPTIDYL PEPTIDASE INHIBITORS FOR THE TREATMENT OR PREVENTION OF DIABETES) | ⤷ 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 |
---|---|---|---|---|
1084705 | C01084705/05 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 62955 21.11.2013 |
1084705 | C300709 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919 |
1506211 | PA2014026,C1506211 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116 |
1532149 | PA2012022 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720 |
1412357 | C 2008 016 | Romania | ⤷ Try a Trial | PRODUCT NAME: SITAGLIPTIN OPTIONAL SUB FORMA DE SARE ACCEPTABILAFARMACEUTIC IN SPECIAL MONOFOSFAT + METFORMIN OPTIONAL SUB FORMA DE SARE ACCEPTABILA FARMACEUTIC IN SPECIALCLORHIDRAT; NATIONAL AUTHORISATION NUMBER: RO EU/1/08/455/001 - RO EU/1/08/455/014; DATE OF NATIONAL AUTHORISATION: 20080716; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): CH 58450 01, CH 58450 02, CH 58450 03; DATE OF FIRST AUTHORISATION IN EEA: 20080408 |
1084705 | SPC/GB14/084 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: LINAGLIPTIN; REGISTERED: UK EU/1/11/707/001-011 20110830 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |