Details for New Drug Application (NDA): 021995

✉ Email this page to a colleague

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

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:	AB	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:	AB	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:	AB	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

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-002	Oct 16, 2006	7,459,428	⤷ Get Started Free
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-001	Oct 16, 2006	6,303,661	⤷ Get Started Free
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-002	Oct 16, 2006	6,303,661	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.