JANUVIA Drug Patent Profile
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Which patents cover Januvia, and what generic alternatives are available?
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
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Questions you can ask:
- What is the 5 year forecast for JANUVIA?
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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 |
![JANUVIA drug patent expirations Drug patent expirations by year for JANUVIA](/p/graph/s/t/JANUVIA-patent-expirations.png)
![Drug Prices for JANUVIA](/p/graph/drug-price/JANUVIA.png)
![Drug Sales Revenue Trends for JANUVIA](/p/graph/drug-sales-revenues/JANUVIA.png)
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 |
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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting JANUVIA
ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING
Exclusivity Expiration: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
Expired US Patents for JANUVIA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Merck Sharp Dohme | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-001 | Oct 16, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Merck Sharp Dohme | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-003 | Oct 16, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Merck Sharp Dohme | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-001 | Oct 16, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Merck Sharp Dohme | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-003 | Oct 16, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Merck Sharp Dohme | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-002 | Oct 16, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Merck Sharp Dohme | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-001 | Oct 16, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Merck Sharp Dohme | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-002 | Oct 16, 2006 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for JANUVIA
See the table below for patents covering JANUVIA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 100606871 | ⤷ Sign Up | |
Netherlands | 300280 | ⤷ Sign Up | |
Australia | 3023397 | ⤷ Sign Up | |
Ukraine | 74912 | BETA-AMINOTETRAHYDROIMIDAZO-(1,2-A)-PYRAZINES AND TETRATRIAZOLO-(4,3-A)-PYRAZINES AS INHIBITORS OF DIPEPTYLPEPTIDASE FOR THE TREATMENT OR PREVENTION OF DIABETES | ⤷ Sign Up |
Hong Kong | 1019204 | ⤷ Sign Up | |
Morocco | 27053 | ⤷ Sign Up | |
Iceland | 2792 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for JANUVIA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1084705 | C01084705/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 57863 18.04.2007 |
1412357 | SPC/GB07/046 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: SITAGLIPTIN PHOSPHATE MONOHYDRATE; REGISTERED: UK EU/1/07/383/001 20070323; UK EU/1/07/383/002 20070323; UK EU/1/07/383/003 20070323; UK EU/1/07/383/004 20070323; UK EU/1/07/383/005 20070323; UK EU/1/07/383/006 20070323; UK EU/1/07/383/007 20070323; UK EU/1/07/383/008 20070323; UK EU/1/07/383/009 20070323; UK EU/1/07/383/010 20070323; UK EU/1/07/383/011 20070323; UK EU/1/07/383/012 20070323; UK EU/1/07/383/013 20070323; UK EU/1/07/383/014 20070323; UK EU/1/07/383/015 20070323; UK EU/1/07/383/016 20070323; UK EU/1/07/383/017 20070323; UK EU/1/07/383/018 20070323 |
0896538 | 08C0008 | France | ⤷ Sign Up | 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 |
0896538 | 07C0035 | France | ⤷ Sign Up | PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE IN FRANCE: EU/1/07/383/001 DU 20070321; REGISTRATION NO/DATE AT EEC: EU/1/07/383/001-018 DU 20070321 |
1084705 | SPC/GB14/086 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: VILDAGLIPTIN; REGISTERED: UK EU/1/07/414/001-017 20070928 |
1084705 | C01084705/03 | Switzerland | ⤷ Sign Up | PRODUCT NAME: SAXAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 59390 05.02.2010 |
1412357 | C 2008 016 | Romania | ⤷ Sign Up | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |