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Last Updated: November 24, 2024

COBICISTAT Drug Patent Profile


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When do Cobicistat patents expire, and what generic alternatives are available?

Cobicistat is a drug marketed by Mylan Labs Ltd and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Cobicistat

A generic version of COBICISTAT was approved as cobicistat by MYLAN LABS LTD on February 7th, 2024.

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Drug patent expirations by year for COBICISTAT
Recent Clinical Trials for COBICISTAT

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SponsorPhase
Center for Primary Care and Public Health (Unisante), University of Lausanne, SwitzerlandPhase 4
Insel Gruppe AG, University Hospital BernPhase 4
University of BernPhase 4

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
Mylan Labs Ltd COBICISTAT cobicistat TABLET;ORAL 209986-001 Feb 7, 2024 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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

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