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Serving leading biopharmaceutical companies globally:

Merck
Deloitte
UBS
Daiichi Sankyo
Healthtrust
QuintilesIMS
Novartis
Covington
Baxter
Fish and Richardson

Generated: November 21, 2017

DrugPatentWatch Database Preview

Etravirine - Generic Drug Details

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What are the generic drug sources for etravirine and what is the scope of etravirine 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 four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Etravirine has one hundred and forty-three patent family members in thirty-nine countries and twelve supplementary protection certificates in eleven countries.

There are five drug master file entries for etravirine. Three suppliers are listed for this compound.
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;ORAL022187-001Jan 18, 2008RXYesNo► Subscribe► Subscribe ► Subscribe
Janssen R And D
INTELENCE
etravirine
TABLET;ORAL022187-003Mar 26, 2012RXYesNo► Subscribe► Subscribe ► Subscribe
Janssen R And D
INTELENCE
etravirine
TABLET;ORAL022187-003Mar 26, 2012RXYesNo► Subscribe► SubscribeYY ► Subscribe
Janssen R And D
INTELENCE
etravirine
TABLET;ORAL022187-001Jan 18, 2008RXYesNo► Subscribe► SubscribeYY ► Subscribe
Janssen R And D
INTELENCE
etravirine
TABLET;ORAL022187-001Jan 18, 2008RXYesNo► Subscribe► SubscribeYY ► Subscribe
Janssen R And D
INTELENCE
etravirine
TABLET;ORAL022187-002Dec 22, 2010RXYesYes► Subscribe► Subscribe ► Subscribe
Janssen R And D
INTELENCE
etravirine
TABLET;ORAL022187-002Dec 22, 2010RXYesYes► Subscribe► SubscribeY ► Subscribe
Janssen R And D
INTELENCE
etravirine
TABLET;ORAL022187-002Dec 22, 2010RXYesYes► Subscribe► SubscribeYY ► Subscribe
Janssen R And D
INTELENCE
etravirine
TABLET;ORAL022187-003Mar 26, 2012RXYesNo► Subscribe► SubscribeYY ► Subscribe
Janssen R And D
INTELENCE
etravirine
TABLET;ORAL022187-002Dec 22, 2010RXYesYes► Subscribe► SubscribeYY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: etravirine

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,530,655HIV replication inhibiting pyrimidines► Subscribe
7,241,458Antiviral compositions► Subscribe
7,015,2212,4-disubstituted triazine derivatives► Subscribe
6,638,932 2,4-disubstituted triazine derivatives► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: etravirine

Country Document Number Estimated Expiration
Germany69905683► Subscribe
South Korea100820605► Subscribe
Eurasian Patent Organization005423► Subscribe
Denmark1129079► Subscribe
Indonesia28376► Subscribe
Australia764472► Subscribe
European Patent Office1225874► Subscribe
South Korea20070036805► Subscribe
New Zealand517025► Subscribe
Israel143024► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ETRAVIRINE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0004France► SubscribePRODUCT 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
2008016Lithuania► SubscribePRODUCT NAME: ETRAVIRINUM; REG. NO/DATE: EU/1/08/468/001 20080828
C/GB09/003United Kingdom► SubscribeSUPPLEMENTARY 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.
2008016,C1002795Lithuania► SubscribePRODUCT NAME: ETRAVIRINUM; REGISTRATION NO/DATE: EU/1/08/468/001 20080828
7Finland► Subscribe
0373Netherlands► Subscribe300373, 20191101, EXPIRES: 20230827
528Luxembourg► Subscribe91528, EXPIRES: 20230828
5/2009Austria► SubscribePRODUCT NAME: ETRAVIRIN UND DESSEN ADDITIONSSALZE
2009000003Germany► SubscribePRODUCT NAME: ETRAVIRIN UND DESSEN ADDITIONSSALZE; REGISTRATION NO/DATE: EU/1/08/468/001 20080828
C033/2008Ireland► SubscribeSPC033/2008: 20090914, EXPIRES: 20230827
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Queensland Health
Deloitte
Express Scripts
Daiichi Sankyo
Moodys
Colorcon
Merck
Accenture
Mallinckrodt
Harvard Business School

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 verifification 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.

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