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Serving leading biopharmaceutical companies globally:

Fuji
Colorcon
Chubb
US Army
QuintilesIMS
Mallinckrodt
Julphar
Queensland Health
Baxter
Cantor Fitzgerald

Generated: October 19, 2017

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 three 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. Three suppliers are listed for this compound. Additional details are available on the cobicistat; darunavir ethanolate profile page.

Summary for NDA: 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 A-S Medication Solutions 50090-1723 50090-1723-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-1723-0)
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)

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 Prods
PREZCOBIX
cobicistat; darunavir ethanolate
TABLET;ORAL205395-001Jan 29, 2015► Subscribe► Subscribe
Janssen Prods
PREZCOBIX
cobicistat; darunavir ethanolate
TABLET;ORAL205395-001Jan 29, 2015► Subscribe► Subscribe
Janssen Prods
PREZCOBIX
cobicistat; darunavir ethanolate
TABLET;ORAL205395-001Jan 29, 2015► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson
Mallinckrodt
Dow
Novartis
Fuji
Baxter
Julphar
McKinsey
Farmers Insurance

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.

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