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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 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.

Suppliers and Packaging for NDA: 205395

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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)
cobicistat; darunavir ethanolate
TABLET;ORAL 205395 NDA A-S Medication Solutions 54569-6594 54569-6594-0 30 TABLET, FILM COATED in 1 BOTTLE (54569-6594-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG;EQ 800MG BASE
Approval Date:Jan 29, 2015TE:RLD:Yes
Patent:7,470,506*PEDPatent Expiration:Dec 23, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:7,700,645*PEDPatent Expiration:Jun 26, 2027Product Flag?Substance Flag?Delist Request?Y
Patent:8,518,987*PEDPatent Expiration:Aug 16, 2024Product 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
cobicistat; darunavir ethanolate
TABLET;ORAL205395-001Jan 29, 20155,843,946*PED► subscribe
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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.