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Last Updated: March 19, 2024

INTELENCE Drug Patent Profile


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

Intelence is a drug marketed by Janssen R And D and is included in one NDA.

The generic ingredient in INTELENCE 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 Intelence

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

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Drug patent expirations by year for INTELENCE
Drug Prices for INTELENCE

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Recent Clinical Trials for INTELENCE

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

SponsorPhase
University of Rome Tor VergataPhase 2
IRCCS Eugenio MedeaPhase 2
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la CienciaPhase 1

See all INTELENCE clinical trials

US Patents and Regulatory Information for INTELENCE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen R And D INTELENCE etravirine TABLET;ORAL 022187-003 Mar 26, 2012 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen R And D INTELENCE etravirine TABLET;ORAL 022187-001 Jan 18, 2008 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Janssen R And D INTELENCE etravirine TABLET;ORAL 022187-002 Dec 22, 2010 AB RX Yes Yes ⤷  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

Expired US Patents for INTELENCE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen R And D INTELENCE etravirine TABLET;ORAL 022187-001 Jan 18, 2008 ⤷  Try a Trial ⤷  Try a Trial
Janssen R And D INTELENCE etravirine TABLET;ORAL 022187-003 Mar 26, 2012 ⤷  Try a Trial ⤷  Try a Trial
Janssen R And D INTELENCE etravirine TABLET;ORAL 022187-001 Jan 18, 2008 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for INTELENCE

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

Supplementary Protection Certificates for INTELENCE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1002795 337 Finland ⤷  Try a Trial
1002795 C01002795/01 Switzerland ⤷  Try a Trial PRODUCT NAME: ETRAVIRIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58483 13.05.2008
1002795 SPC/GB09/003 United Kingdom ⤷  Try a Trial SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB09/003 GRANTED TO JANSSEN PHARMACEUTICA NV IN RESPECT OF THE PRODUCT ETRAVIRINE OPTIONALLY IN A FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6342 DATED 08 DECEMBER 2010 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 31 AUGUST 2023.
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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