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Last Updated: December 5, 2021

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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 two branded drugs marketed by Amneal and Janssen R And D, and is included in two NDAs. There is one patent 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. Two suppliers are listed for this compound.

Summary for etravirine
International Patents:58
US Patents:1
Tradenames:2
Applicants:2
NDAs:2
Drug Master File Entries: 5
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 106
Clinical Trials: 51
Patent Applications: 6,630
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in etravirine?etravirine excipients list
DailyMed Link:etravirine at DailyMed
Recent Clinical Trials for etravirine

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

SponsorPhase
IRCCS Eugenio MedeaPhase 2
University of Rome Tor VergataPhase 2
Merck Frosst Canada Ltd.Phase 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
Janssen R And D INTELENCE etravirine TABLET;ORAL 022187-002 Dec 22, 2010 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Janssen R And D INTELENCE etravirine TABLET;ORAL 022187-002 Dec 22, 2010 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Janssen R And D INTELENCE etravirine TABLET;ORAL 022187-003 Mar 26, 2012 RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Janssen R And D INTELENCE etravirine TABLET;ORAL 022187-003 Mar 26, 2012 RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Amneal ETRAVIRINE etravirine TABLET;ORAL 214196-002 Jun 14, 2021 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 ⤷  Try it Free ⤷  Try it Free
Janssen R And D INTELENCE etravirine TABLET;ORAL 022187-001 Jan 18, 2008 ⤷  Try it Free ⤷  Try it Free
Janssen R And D INTELENCE etravirine TABLET;ORAL 022187-003 Mar 26, 2012 ⤷  Try it Free ⤷  Try it Free
Janssen R And D INTELENCE etravirine TABLET;ORAL 022187-001 Jan 18, 2008 ⤷  Try it Free ⤷  Try it Free
Janssen R And D INTELENCE etravirine TABLET;ORAL 022187-002 Dec 22, 2010 ⤷  Try it Free ⤷  Try it Free
>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 337 Finland ⤷  Try it Free
1002795 122009000003 Germany ⤷  Try it Free PRODUCT NAME: ETRAVIRIN UND DESSEN ADDITIONSSALZE; REGISTRATION NO/DATE: EU/1/08/468/001 20080828
1002795 SPC033/2008 Ireland ⤷  Try it Free SPC033/2008: 20090914, EXPIRES: 20230827
1002795 91528 Luxembourg ⤷  Try it Free 91528, EXPIRES: 20230828
1002795 CA 2009 00004 Denmark ⤷  Try it Free
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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