Details for New Drug Application (NDA): 203045

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NDA 203045 describes ISENTRESS, which is a drug marketed by Msd Sub Merck and is included in three NDAs. It is available from seven suppliers. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ISENTRESS profile page.

The generic ingredient in ISENTRESS 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 203045

Tradename:	ISENTRESS
Applicant:	Msd Sub Merck
Ingredient:	raltegravir potassium
Patents:	2

Pharmacology for NDA: 203045

Mechanism of Action	HIV Integrase Inhibitors

Medical Subject Heading (MeSH) Categories for 203045

Anti-HIV Agents
HIV Integrase Inhibitors

Suppliers and Packaging for NDA: 203045

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045	NDA	Merck Sharp & Dohme LLC	0006-0473	0006-0473-61	60 TABLET, CHEWABLE in 1 BOTTLE (0006-0473-61)
ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045	NDA	Merck Sharp & Dohme LLC	0006-0477	0006-0477-61	60 TABLET, CHEWABLE in 1 BOTTLE (0006-0477-61)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, CHEWABLE;ORAL			Strength	EQ 25MG BASE
Approval Date:	Dec 21, 2011	TE:		RLD:	Yes
Patent:	7,754,731*PED	Patent Expiration:	Sep 11, 2029	Product Flag?		Substance Flag?		Delist Request?	Y

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, CHEWABLE;ORAL			Strength	EQ 100MG BASE
Approval Date:	Dec 21, 2011	TE:		RLD:	Yes
Patent:	7,754,731*PED	Patent Expiration:	Sep 11, 2029	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	8,771,733	Patent Expiration:	Jun 2, 2030	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	TREATMENT OF HIV INFECTION

Expired US Patents for NDA 203045

Show entries

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045-001	Dec 21, 2011	7,169,780*PED	⤷ Try for Free
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045-002	Dec 21, 2011	7,435,734*PED	⤷ Try for Free
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045-002	Dec 21, 2011	7,169,780*PED	⤷ Try for Free
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045-001	Dec 21, 2011	7,217,713*PED	⤷ Try for Free
Msd Sub Merck	ISENTRESS	raltegravir potassium	TABLET, CHEWABLE;ORAL	203045-002	Dec 21, 2011	7,217,713*PED	⤷ Try for Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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