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Last Updated: August 12, 2020

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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 one branded drug marketed by Janssen R And D and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Etravirine has fifty-eight patent family members in thirty-five countries.

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

Summary for ETRAVIRINE
Recent Clinical Trials for ETRAVIRINE

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

SponsorPhase
Clinique du Quartier LatinPhase 4
Merck Frosst Canada Ltd.Phase 4
University of Rome Tor VergataPhase 2

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

Supplementary Protection Certificates for ETRAVIRINE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1002795 SPC033/2008 Ireland   Start Trial SPC033/2008: 20090914, EXPIRES: 20230827
1002795 PA2008016 Lithuania   Start Trial PRODUCT NAME: ETRAVIRINUM; REG. NO/DATE: EU/1/08/468/001 20080828
1002795 C01002795/01 Switzerland   Start Trial PRODUCT NAME: ETRAVIRIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58483 13.05.2008
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Baxter
McKesson
Dow
Johnson and Johnson
Mallinckrodt

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