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Last Updated: March 28, 2024

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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.

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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Drug patent expirations by year for JANUVIA
Drug Prices for JANUVIA

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Drug Sales Revenue Trends for JANUVIA

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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

SponsorPhase
Hospital de Especialidades, Centro Medico Nacional "La Raza", Instituto Mexicano del Seguro SocialPhase 4
National Polytechnic Institute, MexicoPhase 4
Peking University People's HospitalPhase 2

See all JANUVIA clinical trials

Pharmacology 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 one FDA Regulatory Exclusivity.

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

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-001 Oct 16, 2006 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-002 Oct 16, 2006 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-001 Oct 16, 2006 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-002 Oct 16, 2006 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-003 Oct 16, 2006 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-003 Oct 16, 2006 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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
Taiwan I347185 ⤷  Try a Trial
Spain 2158562 ⤷  Try a Trial
Germany 122008000046 ⤷  Try a Trial
Spain 2291907 ⤷  Try a Trial
European Patent Office 1412357 BETA-AMINO-TETRAHYDROIMIDAZO(1, 2-A)PYRAZINES ET BETA-AMINO-TETRAHYDROTRIOAZOLO(4, 3-A)PYRAZINES UTILISEES EN TANT QU'INHIBITEURS DE LA DIPEPTIDYL PEPTIDASE DANS LE TRAITEMENT OU LA PREVENTION DU DIABETE (BETA-AMINO TETRAHYDROIMIDAZO(1,2-A)PYRAZINES AND TETRAHYDROTRIAZOLO(4,3-A)PYRAZINES AS DIPEPTIDYL PEPTIDASE INHIBITORS FOR THE TREATMENT OR PREVENTION OF DIABETES) ⤷  Try a Trial
China 1861077 ⤷  Try a Trial
Netherlands 300280 ⤷  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
0896538 91334 Luxembourg ⤷  Try a Trial CERTIFICATE TITLE: SITAGLIPTIN, OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE, EN PARTICULIER LE SEL PHOSPHATE (JANUVIA); FIRST REGISTRATION: 20070321
1084705 C01084705/01 Switzerland ⤷  Try a Trial PRODUCT NAME: SITAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 57863 18.04.2007
0896538 CA 2007 00030 Denmark ⤷  Try a Trial
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
1412357 C 2008 016 Romania ⤷  Try a Trial 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
1084705 SPC/GB14/084 United Kingdom ⤷  Try a Trial PRODUCT NAME: LINAGLIPTIN; REGISTERED: UK EU/1/11/707/001-011 20110830
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.