JANUVIA Drug Patent Profile
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Which patents cover Januvia, and when can generic versions of Januvia launch?
Januvia is a drug marketed by Merck Sharp Dohme and is included in one NDA. There is one patent protecting this drug and four Paragraph IV challenges.
This drug has fifty-two patent family members in forty countries.
The generic ingredient in JANUVIA is sitagliptin phosphate. There are thirty-five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the sitagliptin phosphate profile page.
DrugPatentWatch® Generic Entry Outlook for Januvia
Januvia 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 $8.9bn, indicating a strong incentive for generic entry (peak sales were $9.2bn in 2020).
There have been twenty-six 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 are thirteen tentative approvals for the generic drug (sitagliptin phosphate), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for JANUVIA
International Patents: | 52 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 82 |
Clinical Trials: | 161 |
Patent Applications: | 34 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for JANUVIA |
Drug Sales Revenues: | Drug sales revenues for JANUVIA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for JANUVIA |
What excipients (inactive ingredients) are in JANUVIA? | JANUVIA excipients list |
DailyMed Link: | JANUVIA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for JANUVIA
Generic Entry Date for JANUVIA*:
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 JANUVIA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Hospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro Social | Phase 4 |
National Polytechnic Institute, Mexico | Phase 4 |
Peking University People's Hospital | Phase 2 |
Pharmacology for JANUVIA
Drug Class | Dipeptidyl Peptidase 4 Inhibitor |
Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for JANUVIA
Paragraph IV (Patent) Challenges for JANUVIA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
JANUVIA | Tablets | sitagliptin phosphate | 50 mg/10 mg 50 mg/20 mg 50 mg/40 mg | 021995 | 1 | 2012-11-06 |
JANUVIA | Tablets | sitagliptin phosphate | 100 mg/20 mg | 021995 | 1 | 2012-06-25 |
JANUVIA | Tablets | sitagliptin phosphate | 100 mg/10 mg and 100 mg/40 mg | 021995 | 1 | 2012-06-19 |
JANUVIA | Tablets | sitagliptin phosphate | 25 mg, 50 mg and 100 mg | 021995 | 6 | 2010-10-18 |
US Patents and Regulatory Information for JANUVIA
JANUVIA is protected by one US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of JANUVIA 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 JANUVIA
Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting JANUVIA
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 JANUVIA
International Patents for JANUVIA
See the table below for patents covering JANUVIA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2423025 | ⤷ Try a Trial | |
Japan | 2006516268 | ⤷ Try a Trial | |
Hong Kong | 1019204 | ⤷ Try a Trial | |
South Korea | 20120014064 | ⤷ Try a Trial | |
Japan | 2001510442 | ⤷ Try a Trial | |
Dominican Republic | P2002000438 | INHIBIDORES DE LA DIPETIDIL PEPTIDASA BETA-AMINO HETEROCÍCLICA PARA EL TRATAMIENTO O LA PREVENCIÓN DE LA DIABETES | ⤷ Try a Trial |
Spain | 2259713 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for JANUVIA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1412357 | C20080004 00019 | Estonia | ⤷ Try a Trial | PRODUCT NAME: JANUMET - SITAGLIPTIIN / METFORMIINVESINIKKLORIID |
0896538 | 08C0008 | France | ⤷ Try a Trial | PRODUCT NAME: VILDAGLIPTINE OU UN DE SES SELS PHARMACETIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/07/414/001 DU 20070926; REGISTRATION NO/DATE AT EEC: EU/1/07/414/001-017 DU 20070926 |
1084705 | PA2014042 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: VILDAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/414/001-010, 2007 09 26 EU/1/07/414/018 20070926 |
1084705 | C300705 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: SITAGLIPTINE; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321 |
1412357 | SPC/GB08/040 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: SITAGLIPTIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE MONOPHOSPHATE, PLUS METFORMIN OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR THE HYDROCHLORIDE.; REGISTERED: CH 58450 01-03 20080408; UK EU/1/08/455/001 20080716; UK EU/1/08/455/002 20080716; UK EU/1/08/455/003 20080716; UK EU/1/08/455/004 20080716; UK EU/1/08/455/005 20080716; UK EU/1/08/455/006 20080716; UK EU/1/08/455/007 20080716; UK EU/1/08/455/008 20080716; UK EU/1/08/455/009 20080716; UK EU/1/08/455/010 20080716; UK EU/1/08/455/011 20080716; UK EU/1/08/455/012 20080716; UK EU/1/08/455/013 20080716; UK EU/1/08/455/014 20080716 |
1084705 | SPC/GB14/084 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: LINAGLIPTIN; REGISTERED: UK EU/1/11/707/001-011 20110830 |
1412357 | C300357 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVA ARDBAAR ZOUT, IN HET BIJZONDER HET MONOFOSFAAT, EN METFORMINE DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |