Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 18, 2019

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 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. 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:1
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 020685
Generic Entry Date for 020685*:
Constraining patent/regulatory exclusivity:
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
Medical Subject Heading (MeSH) Categories for 020685
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:RXDosage:CAPSULE;ORALStrengthEQ 400MG BASE
Approval Date:Mar 13, 1996TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Feb 10, 2021Product 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:RXDosage:CAPSULE;ORALStrengthEQ 200MG BASE
Approval Date:Mar 13, 1996TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Feb 10, 2021Product 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:DISCNDosage:CAPSULE;ORALStrengthEQ 333MG BASE
Approval Date:Dec 17, 1998TE:RLD:No
Patent:  Start TrialPatent Expiration:Feb 10, 2021Product 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 020685-006 Apr 19, 2000   Start Trial   Start Trial
Merck Sharp Dohme CRIXIVAN indinavir sulfate CAPSULE;ORAL 020685-003 Mar 13, 1996   Start Trial   Start Trial
Merck Sharp Dohme CRIXIVAN indinavir sulfate CAPSULE;ORAL 020685-005 Dec 17, 1998   Start Trial   Start Trial
Merck Sharp Dohme CRIXIVAN indinavir sulfate CAPSULE;ORAL 020685-001 Mar 13, 1996   Start Trial   Start Trial
>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.