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JANUVIA Drug Patent Profile

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

See drug prices for JANUVIA

See drug sales revenues for JANUVIA

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

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.

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

FDA Regulatory Exclusivity protecting JANUVIA

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

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
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-001	Oct 16, 2006
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-001	Oct 16, 2006
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-003	Oct 16, 2006
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-003	Oct 16, 2006
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-003	Oct 16, 2006
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-002	Oct 16, 2006

International Patents for JANUVIA

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

Country	Patent Number	Title	Estimated Expiration
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)
Japan	2010248252	METHOD FOR REGULATING GLUCOSE METABOLISM AND REAGENT RELATED THERETO
China	1535681
New Zealand	332707	USE OF DIPEPTIDYL PEPTIDASE IV INHIBITORS (DPIV) FOR LOWERING THE BLOOD GLUCOSE LEVEL IN MAMMALS
World Intellectual Property Organization (WIPO)	03004498
Croatia	P20031098	BETA-AMINO TETRAHIDROIMIDAZO (1,2-A) PIRAZINI I TETRAHIDROTRIAZOLO (4,3-A) PIRAZINI KAO INHIBITORI DIPEPTIDIL PEPTIDAZE ZA LIJEČENJE ILI PREVENCIJU DIJABETESA (BETA-AMINO TETRAHYDROIMIDAZO (1,2-A) PYRAZINES AND TETRAHYDROTRIOAZOLO (4,3-A) PYRAZINES AS DIPEPTIDYL PEPTIDASE INHIBITORS FOR THE TREATMENT OR PREVENTION OF DIABETES)
Israel	159109	DIPEPTIDYL PEPTIDASE INHIBITING 7-(3-AMINO-4-ARYLBUTANOYL)TETRAHYDROIMIDAZO (1,2-A) PYRAZINE AND TETRAHYDROTRIAZOLO (4,3-A) PYRAZINE DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM

Supplementary Protection Certificates for JANUVIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1412357	SPC024/2008	Ireland		SPC024/2008: 20090921, EXPIRES: 20230407
1084705	SPC/GB14/082	United Kingdom		PRODUCT NAME: SITAGLIPTIN; REGISTERED: UK EU/1/07/383/001-018 20070323; UK EU/1/07/382/001-018 20070323
1084705	C300708	Netherlands		PRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: EU/1/11/707/001-011 20111224
1084705	CR 2014 00064	Denmark		PRODUCT NAME: VILDAGLIPTIN; REG. NO/DATE: EU/1/07/414/001-017 20070928
0896538	91382	Luxembourg		91382, EXPIRES: 20220424
1412357	DO 77; 5006-2008	Slovakia		PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
1084705	SPC/GB14/083	United Kingdom		PRODUCT NAME: ALOGLIPTIN; REGISTERED: UK EU/1/13/844 20130923