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Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020685

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NDA 020685 describes CRIXIVAN, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from one supplier. There are two patents 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. One supplier is 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:	2
Therapeutic Class:	Antivirals
Formulation / Manufacturing:	see details

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	N	0006-0571-43
CRIXIVAN	indinavir sulfate	CAPSULE;ORAL	020685	NDA	Merck Sharp & Dohme Corp.	0006-0573	N	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:	➤ Sign Up	Patent Expiration:	Mar 4, 2018	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	➤ Sign Up	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:	➤ Sign Up	Patent Expiration:	Mar 4, 2018	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 020685

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

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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. thinkBiotech performs no independent verifification 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.