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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

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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

Drug patent expirations by year for JANUVIA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for JANUVIA

Generic Entry Date for JANUVIA^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial NDA: 021995 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

See all JANUVIA clinical trials

Pharmacology for JANUVIA

Drug Class	Dipeptidyl Peptidase 4 Inhibitor
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for JANUVIA

A10BH	Dipeptidyl peptidase 4 (DPP-4) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

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

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Glossary

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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	021995-003	Oct 16, 2006		RX	Yes	Yes	⤷ 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			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	021995-001	Oct 16, 2006		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-001	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				⤷ 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

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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	⤷ 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	021995-001	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	021995-003	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	021995-002	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.

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Country	Patent Number	Title	Estimated Expiration
Australia	2493599		⤷ Try a Trial
China	1132578		⤷ Try a Trial
Japan	2012092136	USE OF DIPEPTIDYL PEPTIDASE IV EFFECTOR FOR LOWERING BLOOD GLUCOSE LEVEL IN MAMMAL	⤷ Try a Trial
Norway	321999		⤷ Try a Trial
Japan	2010248253	METHOD FOR REGULATING GLUCOSE METABOLISM AND REAGENT RELATED THERETO	⤷ Try a Trial
Taiwan	I347185		⤷ 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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1412357	300357	Netherlands	⤷ Try a Trial	300357, 20220705, EXPIRES: 20230715
1084705	CA 2014 00063	Denmark	⤷ Try a Trial	PRODUCT NAME: SITAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SITAGLIPTIN PHOSPHAT MONOHYDRAT; REG. NO/DATE: EU/1/07/383/001-024 AND EU/1/07/382/001-024 20070321
1412357	07C0041	France	⤷ Try a Trial	PRODUCT NAME: SITAGLIPTINE, EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET EN PARTICULIER LE PHOSPHATE DE SITAGLIPTINE MONOHYDRATE; REGISTRATION NO/DATE: EU/1/07/383/001 20070323
1084705	CA 2014 00062	Denmark	⤷ Try a Trial	PRODUCT NAME: SAXAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SAXAGLIPTIN HYDROCHLORID; REG. NO/DATE: EU/1/09/545/001-015 20091001
1084705	PA2014041	Lithuania	⤷ Try a Trial	PRODUCT NAME: SITAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/383/001-024, 2007 03 21 EU/1/07/382/001-024 20070321
1412357	C20070004 00113	Estonia	⤷ Try a Trial	PRODUCT NAME: SITAGLIPTIIN;REG NO/DATE: K(2007)1362 23.03.2007
1084705	SPC/GB14/083	United Kingdom	⤷ Try a Trial	PRODUCT NAME: ALOGLIPTIN; REGISTERED: UK EU/1/13/844 20130923
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description