Details for New Drug Application (NDA): 022145

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NDA 022145 describes ISENTRESS HD, which is a drug marketed by Msd Sub Merck and is included in one NDA. It is available from seven suppliers. There are four patents protecting this drug. Additional details are available on the ISENTRESS HD profile page.

The generic ingredient in ISENTRESS HD is raltegravir potassium. There are five drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the raltegravir potassium profile page.

Summary for 022145

Tradename:	ISENTRESS HD
Applicant:	Msd Sub Merck
Ingredient:	raltegravir potassium
Patents:	5

Pharmacology for NDA: 022145

Mechanism of Action	HIV Integrase Inhibitors

Medical Subject Heading (MeSH) Categories for 022145

Anti-HIV Agents
HIV Integrase Inhibitors

Suppliers and Packaging for NDA: 022145

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ISENTRESS	raltegravir potassium	TABLET;ORAL	022145	NDA	Merck Sharp & Dohme LLC	0006-0227	0006-0227-61	60 TABLET, FILM COATED in 1 BOTTLE (0006-0227-61)
ISENTRESS	raltegravir potassium	TABLET;ORAL	022145	NDA	Merck Sharp & Dohme LLC	0006-3080	0006-3080-01	60 TABLET, FILM COATED in 1 BOTTLE (0006-3080-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 400MG BASE
Approval Date:	Oct 12, 2007	TE:		RLD:	Yes
Patent:	⤷ Try for Free	Patent Expiration:	Sep 11, 2029	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Try for Free	Patent Expiration:	Jun 2, 2030	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	TREATMENT OF HIV INFECTION
Patent:	⤷ Try for Free	Patent Expiration:	Jan 28, 2028	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	TREATMENT OF HIV INFECTION

Expired US Patents for NDA 022145

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET;ORAL	022145-001	Oct 12, 2007	⤷ Try for Free	⤷ Try for Free
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET;ORAL	022145-001	Oct 12, 2007	⤷ Try for Free	⤷ Try for Free
Msd Sub Merck	ISENTRESS HD	raltegravir potassium	TABLET;ORAL	022145-002	May 26, 2017	⤷ Try for Free	⤷ Try for Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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