JANUMET Drug Patent Profile
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When do Janumet patents expire, 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 |
---|---|
Eva Pharma | Phase 1 |
Genuine Research Center, Egypt | 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Msd Sub Merck | JANUMET | metformin hydrochloride; sitagliptin phosphate | TABLET;ORAL | 022044-002 | Mar 30, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Msd Sub Merck | JANUMET | metformin hydrochloride; sitagliptin phosphate | TABLET;ORAL | 022044-002 | Mar 30, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Msd Sub Merck | JANUMET | metformin hydrochloride; sitagliptin phosphate | TABLET;ORAL | 022044-001 | Mar 30, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Msd Sub Merck | JANUMET | metformin hydrochloride; sitagliptin phosphate | TABLET;ORAL | 022044-001 | Mar 30, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Msd Sub Merck | 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
See the table below for patents covering JANUMET around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 2493599 | ⤷ Try a Trial | |
China | 1132578 | ⤷ Try a Trial | |
Japan | 2012092136 | USE OF DIPEPTIDYL PEPTIDASE IV EFFECTOR FOR LOWERING BLOOD GLUCOSE LEVEL IN MAMMAL | ⤷ Try a Trial |
Japan | 5165582 | ⤷ Try a Trial | |
Norway | 321999 | ⤷ 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 | C20080004 00019 | Estonia | ⤷ Try a Trial | PRODUCT NAME: JANUMET - SITAGLIPTIIN / METFORMIINVESINIKKLORIID |
0896538 | 300280 | Netherlands | ⤷ Try a Trial | 300280, 20170424, EXPIRES: 20220320 |
1261586 | C300524 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE VAN SAXAGLIPTINE EN METFORMINE, DESGEWENST IN DE VORM VAN FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN; NAT. REGISTRATION NO/DATE: EU/1/11/731/001-012 20111124; FIRST REGISTRATION: |
0896538 | CA 2007 00061 | Denmark | ⤷ Try a Trial | |
1532149 | 132013902118390 | Italy | ⤷ Try a Trial | PRODUCT NAME: LINAGLIPTIN + METFORMINA CLORIDRATO(JENTADUETO); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/12/780/001 A EU/1/12/780/027, 20120720 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |