DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020685

« Back to Dashboard

NDA 020685 describes CRIXIVAN, 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. Additional details are available on the CRIXIVAN profile page.

The generic ingredient in CRIXIVAN is indinavir sulfate. There are two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the indinavir sulfate profile page.

Summary for 020685

Tradename:	CRIXIVAN
Applicant:	Merck Sharp Dohme
Ingredient:	indinavir sulfate
Patents:	1
Formulation / Manufacturing:	see details

Generic Entry Opportunity Date for 020685

Dosage:

CAPSULE;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: 020685

Mechanism of Action

HIV Protease Inhibitors Cytochrome P450 3A4 Inhibitors

Medical Subject Heading (MeSH) Categories for 020685

HIV Protease Inhibitors

Suppliers and Packaging for NDA: 020685

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685	NDA	Merck Sharp & Dohme Corp.	0006-0571	0006-0571-43	360 CAPSULE in 1 BOTTLE (0006-0571-43)
CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685	NDA	Merck Sharp & Dohme Corp.	0006-0573	0006-0573-62	180 CAPSULE in 1 BOTTLE (0006-0573-62)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 400MG BASE
Approval Date:	Mar 13, 1996	TE:		RLD:	Yes
Patent:		Patent Expiration:	Feb 10, 2021	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATING HIV INFECTION WITH INDINAVIR SULFATE IN COMBINATION WITH ANTIRETROVIRAL AGENTS

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	EQ 200MG BASE
Approval Date:	Mar 13, 1996	TE:		RLD:	Yes
Patent:		Patent Expiration:	Feb 10, 2021	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATING HIV INFECTION WITH INDINAVIR SULFATE IN COMBINATION WITH ANTIRETROVIRAL AGENTS

Profile for product number 005

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	EQ 333MG BASE
Approval Date:	Dec 17, 1998	TE:		RLD:	No
Patent:		Patent Expiration:	Feb 10, 2021	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATING HIV INFECTION WITH INDINAVIR SULFATE IN COMBINATION WITH ANTIRETROVIRAL AGENTS

Expired US Patents for NDA 020685

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685-003	Mar 13, 1996
Merck Sharp Dohme	CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685-003	Mar 13, 1996
Merck Sharp Dohme	CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685-005	Dec 17, 1998
Merck Sharp Dohme	CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685-006	Apr 19, 2000
Merck Sharp Dohme	CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685-005	Dec 17, 1998
Merck Sharp Dohme	CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685-001	Mar 13, 1996

Complete Access Available with Subscription