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Last Updated: March 30, 2023

Etravirine - Generic Drug Details


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

Etravirine is the generic ingredient in two branded drugs marketed by Amneal, Carnegie, and Janssen R And D, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for etravirine. Five suppliers are listed for this compound.

Summary for etravirine
Recent Clinical Trials for etravirine

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

SponsorPhase
Fundacion Clinic per a la Recerca Biom├ędicaPhase 4
Jean-Pierre RoutyN/A
Orlando Immunology CenterPhase 4

See all etravirine clinical trials

US Patents and Regulatory Information for etravirine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal ETRAVIRINE etravirine TABLET;ORAL 214196-001 Jun 14, 2021 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Janssen R And D INTELENCE etravirine TABLET;ORAL 022187-002 Dec 22, 2010 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Janssen R And D INTELENCE etravirine TABLET;ORAL 022187-003 Mar 26, 2012 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Carnegie ETRAVIRINE etravirine TABLET;ORAL 215402-001 Apr 13, 2022 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

Expired US Patents for etravirine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen R And D INTELENCE etravirine TABLET;ORAL 022187-002 Dec 22, 2010 ⤷  Sign Up ⤷  Sign Up
Janssen R And D INTELENCE etravirine TABLET;ORAL 022187-003 Mar 26, 2012 ⤷  Sign Up ⤷  Sign Up
Janssen R And D INTELENCE etravirine TABLET;ORAL 022187-002 Dec 22, 2010 ⤷  Sign Up ⤷  Sign Up
Janssen R And D INTELENCE etravirine TABLET;ORAL 022187-001 Jan 18, 2008 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for etravirine

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Janssen-Cilag International NV Intelence etravirine EMEA/H/C/000900
Intelence, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is indicated for the treatment of human-immunodeficiency-virus-type-1 (HIV-1) infection in antiretroviral-treatment-experienced adult patients and in antiretroviral-treatment-experienced paediatric patients from six years of age.This indication is based on week-48 analyses from two phase-III trials in highly pretreated patients where Intelence was investigated in combination with an optimised background regimen (OBR) which included darunavir/ritonavir. The indication in paediatric patients is based on 48-week analyses of a single-arm, phase-II trial in antiretroviral-treatment-experienced paediatric patients.
Authorised no no no 2008-08-28
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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