➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Merck
Medtronic
Mallinckrodt
AstraZeneca
Express Scripts
Harvard Business School

Last Updated: January 24, 2021

DrugPatentWatch Database Preview

Etravirine - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

What are the generic drug 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
Merck Frosst Canada Ltd.Phase 4
Clinique du Quartier LatinPhase 4
IRCCS Eugenio MedeaPhase 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 022187-002 Dec 22, 2010 RX Yes Yes   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
Janssen R And D INTELENCE etravirine TABLET;ORAL 022187-002 Dec 22, 2010 RX Yes Yes   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 Y   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 022187-003 Mar 26, 2012   Start Trial   Start Trial
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 022187-001 Jan 18, 2008   Start Trial   Start Trial
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 022187-001 Jan 18, 2008   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 122009000003 Germany   Start Trial PRODUCT NAME: ETRAVIRIN UND DESSEN ADDITIONSSALZE; REGISTRATION NO/DATE: EU/1/08/468/001 20080828
1002795 300373 Netherlands   Start Trial 300373, 20191101, EXPIRES: 20230827
1002795 337 Finland   Start Trial
1002795 CA 2009 00004 Denmark   Start Trial
1002795 SPC033/2008 Ireland   Start Trial SPC033/2008: 20090914, EXPIRES: 20230827
1002795 SPC/GB09/003 United Kingdom   Start 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Moodys
Merck
Mallinckrodt
Colorcon
Express Scripts
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.