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Last Updated: January 20, 2021

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INTELENCE Drug 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. There are three patents protecting this drug.

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

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

US ANDA Litigation and Generic Entry Outlook for Intelence

Intelence was eligible for patent challenges on January 18, 2012.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 16, 2021. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Drug patent expirations by year for INTELENCE
Drug Prices for INTELENCE

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Generic Entry Opportunity Date for INTELENCE
Generic Entry Date for INTELENCE*:
Constraining patent/regulatory exclusivity:
FDA exclusivity
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for INTELENCE

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

SponsorPhase
University of Rome Tor VergataPhase 2
IRCCS Eugenio MedeaPhase 2
Fundacio Lluita Contra la SIDAPhase 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   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 Y   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 022187-002 Dec 22, 2010 RX Yes Yes   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
Janssen R And D INTELENCE etravirine TABLET;ORAL 022187-002 Dec 22, 2010 RX Yes Yes   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 INTELENCE

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 INTELENCE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1002795 337 Finland   Start Trial
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.
1002795 300373 Netherlands   Start Trial 300373, 20191101, EXPIRES: 20230827
1002795 SZ 5/2009 Austria   Start Trial PRODUCT NAME: ETRAVIRIN UND DESSEN ADDITIONSSALZE
1002795 09C0004 France   Start Trial PRODUCT NAME: ETRAVIRINE AINSI QUE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/08/468/001 DU 20080828; REGISTRATION NO/DATE AT EEC: EU/1/08/468/001 DU 20080828
1002795 CA 2009 00004 Denmark   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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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.