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Last Updated: August 4, 2021

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Cobicistat; darunavir - Generic Drug Details

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What are the generic sources for cobicistat; darunavir and what is the scope of freedom to operate?

Cobicistat; darunavir is the generic ingredient in two branded drugs marketed by Janssen Prods and is included in two NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Cobicistat; darunavir has three hundred and thirty patent family members in thirty-nine countries.

There are five drug master file entries for cobicistat; darunavir. One supplier is listed for this compound.

Summary for cobicistat; darunavir
International Patents:330
US Patents:12
Tradenames:2
Applicants:1
NDAs:2
Drug Master File Entries: 5
Finished Product Suppliers / Packagers: 1
Clinical Trials: 53
DailyMed Link:cobicistat; darunavir at DailyMed
Recent Clinical Trials for cobicistat; darunavir

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

SponsorPhase
The Crofoot Research Center, Inc.Phase 4
University of ParmaPhase 2
Azienda Ospedaliero-Universitaria di ParmaPhase 2

See all cobicistat; darunavir clinical trials

Paragraph IV (Patent) Challenges for COBICISTAT; DARUNAVIR
Tradename Dosage Ingredient NDA Submissiondate
PREZCOBIX TABLET;ORAL cobicistat; darunavir 205395 2020-07-24

US Patents and Regulatory Information for cobicistat; darunavir

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Prods SYMTUZA cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Janssen Prods SYMTUZA cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Janssen Prods SYMTUZA cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Janssen Prods SYMTUZA cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Janssen Prods PREZCOBIX cobicistat; darunavir TABLET;ORAL 205395-001 Jan 29, 2015 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever 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 cobicistat; darunavir

Supplementary Protection Certificates for cobicistat; darunavir

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2049506 CR 2015 00060 Denmark ⤷  Free Forever Trial PRODUCT NAME: COBICISTAT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/830/001-002 20130527
2487163 2017002 Norway ⤷  Free Forever Trial PRODUCT NAME: KOBICISTAT ELLER FARMASOEYTISK; REG. NO/DATE: EU/1/15/1025 20150810
2487166 1790001-0 Sweden ⤷  Free Forever 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
2487162 122016000103 Germany ⤷  Free Forever Trial PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ ODER SOLVAT DAVON UND DARUNAVIR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ ODER SOLVAT DAVON, INSBESONDERE DARUNAVIRETHANOLAT; REGISTRATION NO/DATE: EU/1/14/967 20141119
2049506 2015C/058 Belgium ⤷  Free Forever Trial PRODUCT NAME: COBICISTAT; AUTHORISATION NUMBER AND DATE: EU/1/13/830/001
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Johnson and Johnson
McKesson
Baxter
Harvard Business School
Mallinckrodt

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