Details for New Drug Application (NDA): 021995

NDA 021995 describes JANUVIA, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from three suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the JANUVIA profile page.

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.

Summary for 021995

Tradename:	JANUVIA
Applicant:	Merck Sharp Dohme
Ingredient:	sitagliptin phosphate
Patents:	1

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 021995

Constraining patent/regulatory exclusivity:

7,326,708*PED

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.

Pharmacology for NDA: 021995

Mechanism of Action

Dipeptidyl Peptidase 4 Inhibitors

Medical Subject Heading (MeSH) Categories for 021995

Dipeptidyl-Peptidase IV Inhibitors

Hypoglycemic Agents

Incretins

Suppliers and Packaging for NDA: 021995

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995	NDA	Merck Sharp & Dohme LLC	0006-0112	0006-0112-28	100 BLISTER PACK in 1 CARTON (0006-0112-28) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0006-0112-01)
JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995	NDA	Merck Sharp & Dohme LLC	0006-0112	0006-0112-31	30 TABLET, FILM COATED in 1 BOTTLE (0006-0112-31)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 25MG BASE
Approval Date:	Oct 16, 2006	TE:		RLD:	Yes
Patent:	7,326,708*PED	Patent Expiration:	May 24, 2027	Product Flag?		Substance Flag?		Delist Request?	Y

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 50MG BASE
Approval Date:	Oct 16, 2006	TE:		RLD:	Yes
Patent:	7,326,708*PED	Patent Expiration:	May 24, 2027	Product Flag?		Substance Flag?		Delist Request?	Y

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 100MG BASE
Approval Date:	Oct 16, 2006	TE:		RLD:	Yes
Patent:	7,326,708*PED	Patent Expiration:	May 24, 2027	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 021995

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	6,890,898
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-002	Oct 16, 2006	6,303,661
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-003	Oct 16, 2006	6,303,661
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-001	Oct 16, 2006	6,303,661
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-002	Oct 16, 2006	7,078,381
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-003	Oct 16, 2006	7,078,381
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-002	Oct 16, 2006	6,890,898

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