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Last Updated: September 25, 2022

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 are three patents protecting this drug and four Paragraph IV challenges.

This drug has one hundred and twenty-seven patent family members in forty-six 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 2019 were $6.9bn, indicating a strong incentive for generic entry (peak sales were $7.2bn in 2018).

There have been twenty-four 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 twelve 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

See drug sales revenues for JANUVIA

DrugPatentWatch® Estimated Generic Entry Opportunity 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
Peking University People's HospitalPhase 2
Rabin Medical CenterPhase 2
University of PennsylvaniaPhase 4

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 three US patents and four FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of JANUVIA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Beta-amino tetrahydroimidazo (1, 2-a) pyrazines and tetrahydrotrioazolo (4, 3-a) pyrazines as dipeptidyl peptidase inhibitors for the treatment or prevention of diabetes
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting JANUVIA

INFORMATION ADDED TO THE LABELING REGARDING EFFICACY AND SAFETY OF THE CONTINUATION OF SITAGLIPTIN COMPARED WITH THE WITHDRAWAL OF SITAGLIPTIN DURING INITIATION AND TITRATION OF INSULIN GLARGINE IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS
Exclusivity Expiration: See Plans and Pricing

ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-003 Oct 16, 2006 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-001 Oct 16, 2006 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-001 Oct 16, 2006 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-002 Oct 16, 2006 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-003 Oct 16, 2006 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

When does loss-of-exclusivity occur for JANUVIA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 4705
Estimated Expiration: See Plans and Pricing

Patent: 4185
Estimated Expiration: See Plans and Pricing

Australia

Patent: 04253889
Estimated Expiration: See Plans and Pricing

Austria

Patent: 3003
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0411726
Estimated Expiration: See Plans and Pricing

Canada

Patent: 29400
Estimated Expiration: See Plans and Pricing

China

Patent: 32949
Estimated Expiration: See Plans and Pricing

Patent: 0430397
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 60266
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 17
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0070534
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 06936
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 54263
Estimated Expiration: See Plans and Pricing

Dominican Republic

Patent: 004000941
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 056245
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 9042
Estimated Expiration: See Plans and Pricing

Patent: 0600095
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 54263
Estimated Expiration: See Plans and Pricing

Georgia, Republic of

Patent: 0084489
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2004008938
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 95144
Estimated Expiration: See Plans and Pricing

Iceland

Patent: 92
Estimated Expiration: See Plans and Pricing

Patent: 83
Estimated Expiration: See Plans and Pricing

Israel

Patent: 2563
Estimated Expiration: See Plans and Pricing

Japan

Patent: 63768
Estimated Expiration: See Plans and Pricing

Patent: 06516268
Estimated Expiration: See Plans and Pricing

Jordan

Patent: 25
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 9595
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 05013931
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 405
Estimated Expiration: See Plans and Pricing

Patent: 0208
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 861
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 4026
Estimated Expiration: See Plans and Pricing

Norway

Patent: 5371
Estimated Expiration: See Plans and Pricing

Patent: 060362
Estimated Expiration: See Plans and Pricing

Peru

Patent: 050696
Estimated Expiration: See Plans and Pricing

Poland

Patent: 54263
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 54263
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 873
Estimated Expiration: See Plans and Pricing

Patent: 050947
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 54263
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0509933
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1013431
Estimated Expiration: See Plans and Pricing

Patent: 1016569
Estimated Expiration: See Plans and Pricing

Patent: 060026061
Estimated Expiration: See Plans and Pricing

Patent: 080022232
Estimated Expiration: See Plans and Pricing

Spain

Patent: 91907
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 47185
Estimated Expiration: See Plans and Pricing

Patent: 0524610
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 05329
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 026
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering JANUVIA around the world.

Country Patent Number Title Estimated Expiration
South Korea 20040010842 See Plans and Pricing
Russian Federation 2305553 НОВЫЕ ИНГИБИТОРЫ ДИПЕПТИДИЛПЕПТИДАЗЫ IV И ИХ ПРИМЕНЕНИЕ ДЛЯ ПОНИЖЕНИЯ КРОВЯНОГО ДАВЛЕНИЯ (NEW DIPEPTIDYL PEPTIDASE IV INHIBITORS AND USES THEREOF AS HYPOTENSIVE AGENT) See Plans and Pricing
China 1861077 See Plans and Pricing
Germany 602004008938 See Plans and Pricing
Hong Kong 1068882 See Plans and Pricing
Iceland 2792 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for JANUVIA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1084705 CR 2014 00064 Denmark See Plans and Pricing PRODUCT NAME: VILDAGLIPTIN; REG. NO/DATE: EU/1/07/414/001-017 20070928
1412357 C200700039 Spain See Plans and Pricing PRODUCT NAME: SITAGLIPTINA; NATIONAL AUTHORISATION NUMBER: EU/1/07/383/001-018; DATE OF AUTHORISATION: 20070321; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/07/383/001-018; DATE OF FIRST AUTHORISATION IN EEA: 20070321
1412357 CA 2007 00040 Denmark See Plans and Pricing
1412357 C20070004 00113 Estonia See Plans and Pricing PRODUCT NAME: SITAGLIPTIIN;REG NO/DATE: K(2007)1362 23.03.2007
1084705 SPC/GB14/083 United Kingdom See Plans and Pricing PRODUCT NAME: ALOGLIPTIN; REGISTERED: UK EU/1/13/844 20130923
1412357 50/2008 Austria See Plans and Pricing 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
>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.