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Last Updated: November 18, 2019

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PREZCOBIX Drug Profile

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Which patents cover Prezcobix, and what generic alternatives are available?

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

This drug has three hundred and thirty-two patent family members in forty-one countries.

The generic ingredient in PREZCOBIX is cobicistat; darunavir. 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 profile page.

Drug patent expirations by year for PREZCOBIX
Drug Prices for PREZCOBIX

See drug prices for PREZCOBIX

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

Recent Litigation for PREZCOBIX

Identify potential future generic entrants

District Court Litigation
Case NameDate
JANSSEN PRODUCTS, L.P. v. AMNEAL PHARMACEUTICALS, LLC2018-12-26
JANSSEN PRODUCTS, L.P. v. DR. REDDY'S LABORATORIES, INC.2018-05-24
JANSSEN PRODUCTS, L.P. v. AUROBINDO PHARMA LTD.2017-09-07

See all PREZCOBIX litigation

PTAB Litigation
PetitionerDate
Lupin Limited2015-04-09

See all PREZCOBIX litigation

Synonyms for PREZCOBIX
Cobicistat / darunavir
Cobicistat and darunavir
Cobicistat mixture with darunavir
Darunavir / Cobicistat
S900006400

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   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
Janssen Prods PREZCOBIX cobicistat; darunavir TABLET;ORAL 205395-001 Jan 29, 2015 RX Yes Yes   Start Trial   Start Trial   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
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
2487162 CA 2017 00002 Denmark   Start Trial PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF OG DARUNAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, ISAER DARUNAVIRETHANOLAT; REG. NO/DATE: EU/1/14/967/001 20141121
2487166 59/2016 Austria   Start Trial PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON UND TENOFOVIR ALAFENAMID ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE TENOFOVIR ALAFENAMID FUMARAT; REGISTRATION NO/DATE: EU/1/15/1061 (MITTEILUNG) 20151123
2487162 61/2016 Austria   Start Trial PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON UND DARUNAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON, INSVBESONDERE DARUNAVIR-ETHANOLAT; REGISTRATION NO/DATE: EU/1/14/967 (MITTEILUNG) 20141121
2487163 93353 Luxembourg   Start Trial PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI ET ATAZANAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE SULFATE D'ATAZANAVIR; AUTHORISATION NUMBER AND DATE: EU/1/15/1025
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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