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
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 |
---|---|
National Polytechnic Institute, Mexico | Phase 4 |
Hospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro Social | 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Merck Sharp Dohme | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-003 | Oct 16, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Merck Sharp Dohme | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-001 | Oct 16, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Merck Sharp Dohme | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-003 | Oct 16, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Merck Sharp Dohme | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-001 | Oct 16, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Merck Sharp Dohme | JANUVIA | sitagliptin phosphate | TABLET;ORAL | 021995-002 | Oct 16, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
Germany | 60236767 | ⤷ Try a Trial | |
Spain | 2158562 | ⤷ Try a Trial | |
Jordan | 2230 | مثبطات انزيم داي ببتيديل المحتوي على حلقه غير متجانسه من حلقات البيتا امينو للعلاج او للوقايه من مرض السكري (BETA AMINO HETEROCYCLIC DIPEPTIDYL PEPTIDASE INHIBITORS FOR THE TREATMETN OR PREVENTION OF DIABETES) | ⤷ Try a Trial |
Russian Federation | 2189233 | ПРИМЕНЕНИЕ СНИЖАЮЩИХ АКТИВНОСТЬ ЭФФЕКТОРОВ ДИПЕПТИДИЛ ПЕПТИДАЗЫ (DP IV) И СООТВЕТСТВЕННО ЭНЗИМА DP IV С АНАЛОГИЧНОЙ АКТИВНОСТЬЮ ДЛЯ СНИЖЕНИЯ УРОВНЯ САХАРА В КРОВИ (USE OF EFFECTORS DECREASING ACTIVITY OF DIPEPTIDYL-PEPTIDASE (DP IV) AND ENZYME DP IV RESPECTIVELY WITH SIMILAR ACTIVITY FOR DECREASE OF BLOOD GLUCOSE LEVEL) | ⤷ Try a Trial |
Mexico | PA04000018 | BETA-AMINO TETRAHIDROIMIDAZO (1,2-A) PIRAZINAS Y TETRAHIDROTRIOAZOLO (4,3-A) PIRAZINAS COMO INHIBIDORES DE LA DIPEPTIDIL PEPTIDASA PARA EL TRATAMIENTO O PREVENCION DE DIABETES. (BETA-AMINO TETRAHYDROIMIDAZO (1, 2-A) PYRAZINES AND TETRAHYDROTRIOAZOLO (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 JANUVIA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0896538 | 91382 | Luxembourg | ⤷ Try a Trial | 91382, EXPIRES: 20220424 |
1084705 | CR 2014 00066 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ALOGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER ALOGLIPTIN BENZOATE; REG. NO/DATE: EU/1/13/844/001-027 20130923 |
1412357 | 91360 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: SITAGLIPTIN; AUTHORISATION NUMBER AND DATE: EU/1/07/383/001-018 20070323 |
1412357 | 50/2008 | Austria | ⤷ Try a Trial | PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE ALS MONOPHOSPHAT, UND METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REGISTRATION: CH 58450 01-03 20080408 |
1412357 | C300287 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER SITAGLIPTINE FOSFAAT MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |