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Last Updated: March 29, 2024

ETRAVIRINE Drug Patent Profile


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

Etravirine is a drug marketed by Amneal and Carnegie and is included in two NDAs.

The generic ingredient in ETRAVIRINE is etravirine. There are five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the etravirine profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Etravirine

A generic version of ETRAVIRINE was approved as etravirine by AMNEAL on June 14th, 2021.

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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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Carnegie ETRAVIRINE etravirine TABLET;ORAL 215402-001 Apr 13, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal ETRAVIRINE etravirine TABLET;ORAL 214196-002 Jun 14, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  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 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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