.

BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Cerilliant
Daiichi Sankyo
McKinsey
Queensland Health
Novartis
Farmers Insurance
Boehringer Ingelheim
UBS
Johnson and Johnson
Argus Health

Generated: December 13, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205395

« Back to Dashboard

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 eight 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:1
Applicant:1
Ingredient:1
Patents:8
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 59676-575-30 30 TABLET, FILM COATED in 1 BOTTLE (59676-575-30)
PREZCOBIX cobicistat; darunavir ethanolate TABLET;ORAL 205395 NDA REMEDYREPACK INC. 70518-0714 70518-0714-0 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0714-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG;EQ 800MG BASE
Approval Date:Jan 29, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 27, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:► SubscribePatent Expiration:Dec 23, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:► SubscribePatent Expiration:Jun 26, 2027Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 205395

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen ProdsPREZCOBIXcobicistat; darunavir ethanolateTABLET;ORAL205395-001Jan 29, 2015► Subscribe► Subscribe
Janssen ProdsPREZCOBIXcobicistat; darunavir ethanolateTABLET;ORAL205395-001Jan 29, 2015► Subscribe► Subscribe
Janssen ProdsPREZCOBIXcobicistat; darunavir ethanolateTABLET;ORAL205395-001Jan 29, 2015► Subscribe► Subscribe
Janssen ProdsPREZCOBIXcobicistat; darunavir ethanolateTABLET;ORAL205395-001Jan 29, 2015► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.



Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Colorcon
US Department of Justice
McKinsey
Argus Health
QuintilesIMS
Teva
Farmers Insurance
Chubb
Cantor Fitzgerald

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot