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INTELENCE Drug Profile

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Intelence is a drug marketed by Janssen R And D and is included in one NDA. It is available from four suppliers. There are four patents protecting this drug.

This drug has one hundred and thirty-one patent family members in thirty-nine countries.

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

Summary for Tradename: INTELENCE

Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list4
Bulk Api Vendors: see list71
Clinical Trials: see list9
Patent Applications: see list1,008
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:INTELENCE at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen R And D
INTELENCE
etravirine
TABLET;ORAL022187-003Mar 26, 2012RXYesNo6,878,717► subscribe ► subscribe
Janssen R And D
INTELENCE
etravirine
TABLET;ORAL022187-002Dec 22, 2010RXYesYes7,037,917► subscribeYY ► subscribe
Janssen R And D
INTELENCE
etravirine
TABLET;ORAL022187-001Jan 18, 2008RXYesNo6,878,717► subscribe ► subscribe
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Non-Orange Book Patents for Tradename: INTELENCE

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
7,015,2212,4-disubstituted triazine derivatives► subscribe
7,241,458Antiviral compositions► 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 Tradename: INTELENCE

Country Document Number Estimated Expiration
Spain2193664► subscribe
Ukraine74797► subscribe
Czech Republic300712► 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: INTELENCE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2008016,C1002795Lithuania► subscribePRODUCT NAME: ETRAVIRINUM; REGISTRATION NO/DATE: EU/1/08/468/001 20080828
0373Netherlands► subscribe300373, 20191101, EXPIRES: 20230827
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.
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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 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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