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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Farmers Insurance
Chinese Patent Office
Fish and Richardson
Teva
McKinsey
US Department of Justice
McKesson
Citi

Generated: April 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205395

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NDA 205395 describes PREZCOBIX, which is a drug marketed by Janssen Prods and is included in one NDA. It is available from two suppliers. There are six patents protecting this drug. Additional details are available on the PREZCOBIX profile page.

The generic ingredient in PREZCOBIX is cobicistat; darunavir ethanolate. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cobicistat; darunavir ethanolate profile page.
Summary for 205395
Tradename:PREZCOBIX
Applicant:Janssen Prods
Ingredient:cobicistat; darunavir ethanolate
Patents:6
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 205395
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREZCOBIX cobicistat; darunavir ethanolate TABLET;ORAL 205395 NDA Janssen Products LP 59676-575 N 59676-575-30
PREZCOBIX cobicistat; darunavir ethanolate TABLET;ORAL 205395 NDA REMEDYREPACK INC. 70518-0714 N 70518-0714-0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG;EQ 800MG BASE
Approval Date:Jan 29, 2015TE: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:Sep 3, 2029Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF HIV-1 INFECTION IN ADULTS WITH NO DARUNAVIR RESISTANCE-ASSOCIATED SUBSTITUTIONS

Expired US Patents for NDA 205395

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Prods PREZCOBIX cobicistat; darunavir ethanolate TABLET;ORAL 205395-001 Jan 29, 2015 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Prods PREZCOBIX cobicistat; darunavir ethanolate TABLET;ORAL 205395-001 Jan 29, 2015 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Prods PREZCOBIX cobicistat; darunavir ethanolate TABLET;ORAL 205395-001 Jan 29, 2015 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Prods PREZCOBIX cobicistat; darunavir ethanolate TABLET;ORAL 205395-001 Jan 29, 2015 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Chinese Patent Office
McKesson
QuintilesIMS
Merck
Harvard Business School
Mallinckrodt
Cipla
Medtronic

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