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US Department of Justice
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Farmers Insurance
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Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021976

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NDA 021976 describes PREZISTA, which is a drug marketed by Janssen Prods and is included in two NDAs. It is available from six suppliers. There are four patents protecting this drug and two Paragraph IV challenges. Additional details are available on the PREZISTA profile page.

The generic ingredient in PREZISTA is darunavir ethanolate. There are twenty-five drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the darunavir ethanolate profile page.
Summary for 021976
Applicant:Janssen Prods
Ingredient:darunavir ethanolate
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021976
Suppliers and Packaging for NDA: 021976
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREZISTA darunavir ethanolate TABLET;ORAL 021976 NDA A-S Medication Solutions 50090-1327 N 50090-1327-0
PREZISTA darunavir ethanolate TABLET;ORAL 021976 NDA A-S Medication Solutions 50090-1491 N 50090-1491-0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jun 23, 2006TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Dec 23, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Try a Free TrialPatent Expiration:Jun 26, 2027Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Try a Free TrialPatent Expiration:Aug 16, 2024Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021976

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