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Last Updated: July 8, 2020

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PREZCOBIX Drug Profile


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When do Prezcobix patents expire, and when can generic versions of Prezcobix launch?

Prezcobix is a drug marketed by Janssen Prods and is included in one NDA. There are four patents protecting this drug.

This drug has three hundred and eighteen patent family members in thirty-nine countries.

The generic ingredient in PREZCOBIX is cobicistat; darunavir. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cobicistat; darunavir profile page.

US ANDA Litigation and Generic Entry Outlook for Prezcobix

Prezcobix was eligible for patent challenges on August 27, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 4, 2032. This may change due to patent challenges or generic licensing.

There have been eleven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for PREZCOBIX
Drug Prices for PREZCOBIX

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Generic Entry Opportunity Date for PREZCOBIX
Generic Entry Date for PREZCOBIX*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for PREZCOBIX

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Janssen Pharmaceutical K.K.Phase 4
Stanford UniversityPhase 2/Phase 3
Janssen Scientific Affairs, LLCPhase 2/Phase 3

See all PREZCOBIX clinical trials

US Patents and Regulatory Information for PREZCOBIX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Prods PREZCOBIX cobicistat; darunavir TABLET;ORAL 205395-001 Jan 29, 2015 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Janssen Prods PREZCOBIX cobicistat; darunavir TABLET;ORAL 205395-001 Jan 29, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Janssen Prods PREZCOBIX cobicistat; darunavir TABLET;ORAL 205395-001 Jan 29, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for PREZCOBIX

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

Supplementary Protection Certificates for PREZCOBIX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0810209 CA 2007 00017 Denmark   Start Trial PRODUCT NAME: DARUNAVIR OG ET FARMACEUTISK ACCEPTABELT SALT DERAF
2487166 1790001-0 Sweden   Start Trial PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND TENOFOVIR ALAFENAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REG. NO/DATE: EU/1/15/1061 20151123
2487163 2017002 Norway   Start Trial PRODUCT NAME: KOBICISTAT ELLER FARMASOEYTISK; REG. NO/DATE: EU/1/15/1025 20150810
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
Medtronic
McKinsey
McKesson
Dow
Mallinckrodt

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 verification 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.