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Last Updated: March 29, 2024

Cobicistat - Generic Drug Details


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

Cobicistat is the generic ingredient in six branded drugs marketed by Mylan Labs Ltd, Gilead Sciences Inc, and Janssen Prods, and is included in six NDAs. There are twenty-four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Cobicistat has two hundred and eighty-seven patent family members in thirty-nine countries.

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

Recent Clinical Trials for cobicistat

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

SponsorPhase
Maastricht University Medical CenterPhase 4
Food and Drug Administration (FDA)Phase 1
Spaulding Clinical Research LLCPhase 1

See all cobicistat clinical trials

Medical Subject Heading (MeSH) Categories for cobicistat
Paragraph IV (Patent) Challenges for COBICISTAT
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TYBOST Tablets cobicistat 150 mg 203094 1 2016-11-14

US Patents and Regulatory Information for cobicistat

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead Sciences Inc GENVOYA cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 207561-001 Nov 5, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Gilead Sciences Inc GENVOYA cobicistat; elvitegravir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 207561-001 Nov 5, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Janssen Prods SYMTUZA cobicistat; darunavir; emtricitabine; tenofovir alafenamide fumarate TABLET;ORAL 210455-001 Jul 17, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Gilead Sciences Inc STRIBILD cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203100-001 Aug 27, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Janssen Prods PREZCOBIX cobicistat; darunavir TABLET;ORAL 205395-001 Jan 29, 2015 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for cobicistat

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Gilead Sciences Ireland UC Tybost cobicistat EMEA/H/C/002572
Tybost is indicated as a pharmacokinetic enhancer of atazanavir 300 mg once daily or darunavir 800 mg once daily as part of antiretroviral combination therapy in human immunodeficiency virus-1 (HIV-1) infected adults and adolescents aged 12 years and older:weighing at least 35 kg co‑administered with atazanavir orweighing at least 40 kg co‑administered with darunavir.
Authorised no no no 2013-09-19
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for cobicistat

Country Patent Number Title Estimated Expiration
Australia 2017201473 Tablets for combination therapy ⤷  Try a Trial
Denmark 2393485 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2008010921 ⤷  Try a Trial
Hungary E025565 ⤷  Try a Trial
Canada 2720856 UTILISATION DE PARTICULES SUPPORTS SOLIDES POUR AMELIORER L'APTITUDE AU TRAITEMENT D'UN AGENT PHARMACEUTIQUE (THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE PROCESSABILITY OF A PHARMACEUTICAL AGENT) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for cobicistat

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2049506 PA2015040,C2049506 Lithuania ⤷  Try a Trial PRODUCT NAME: KOBICISTATAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/13/830/001 - 002 20130524
2487166 1790001-0 Sweden ⤷  Try a Trial PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND TENOFOVIR ALAFENAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR ALAFENAMIDE FUMARATE; FIRST MARKETING AITHORIZATION NUMBER SE: EU/1/15/1061, 2015-11-23
2487163 122016000120 Germany ⤷  Try a Trial PRODUCT NAME: COBICISTAT ODER EIN PHARMAZEUTISCHES AKZEPTABLES SALZ DAVON UND ATAZANAVIR ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1025 20150713
2487162 1790003-6 Sweden ⤷  Try a Trial PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND DARUNAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR DARUNAVIR ETHANOLATE FIRST REG.NO: EU/1/14/967, 2014-11-21
2487166 PA2016038 Lithuania ⤷  Try a Trial PRODUCT NAME: ELVITEGRAVIRAS + KOBICISTATAS + EMTRICITABINAS + TENOFOVIRALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061 20151119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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