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 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
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Questions you can ask:
- What is the 5 year forecast for JANUMET?
- What are the global sales for JANUMET?
- What is Average Wholesale Price for JANUMET?
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: | 20 |
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 |
---|---|
Galenicum Health | Phase 1 |
Genuine Research Center, Egypt | Phase 1 |
Eva Pharma | Phase 1 |
Pharmacology for JANUMET
Drug Class | Biguanide Dipeptidyl Peptidase 4 Inhibitor |
Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
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.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of JANUMET is ⤷ Try for Free.
This potential generic entry date is based on patent 7,326,708.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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) | 03015775 | ⤷ Try for Free | |
Japan | 2001510442 | ⤷ Try for Free | |
South Korea | 20080022232 | CRYSTALLINE MONOHYDRATE OF A PHOSPHORIC ACID SALT OF A DIPEPTIDYL PEPTIDASE-IV INHIBITOR | ⤷ Try for Free |
European Patent Office | 2289513 | ⤷ Try for Free | |
Argentina | 044705 | SAL DE ACIDO FOSFORICO DE UN INHIBIDOR DE LA DIPEPTIDIL PEPTIDASA -IV | ⤷ Try for Free |
Ecuador | SP056245 | SAL DE ÁCIDO FOSFÓRICO DE UN INHIBIDOR DE LA DIPEPTIDIL PEPTIDASA-IV. | ⤷ Try for Free |
European Patent Office | 1520582 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for JANUMET
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1084705 | C01084705/01 | Switzerland | ⤷ Try for Free | PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 57863 18.04.2007 |
1084705 | CA 2014 00062 | Denmark | ⤷ Try for Free | PRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SAXAGLIPTIN HYDROCHLORID; REG. NO/DATE: EU/1/09/545/001-015 20091001 |
1506211 | 92496 | Luxembourg | ⤷ Try for Free | PRODUCT NAME: COMBINAISON DE DAPAGLIFLOZINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DE METFORMINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,TELLE QUE PROTEGEE PAR LE BREVET DE BASE EP1506211 B1 |
1506211 | CR 2014 00037 | Denmark | ⤷ Try for Free | PRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116 |
1532149 | PA2012022 | Lithuania | ⤷ Try for Free | PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720 |
1532149 | C300569 | Netherlands | ⤷ Try for Free | PRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720 |
1412357 | C20070004 00113 | Estonia | ⤷ Try for Free | PRODUCT NAME: SITAGLIPTIIN;REG NO/DATE: K(2007)1362 23.03.2007 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for JANUMET
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