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Last Updated: July 6, 2020

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Rilpivirine hydrochloride - Generic Drug Details

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What are the generic drug sources for rilpivirine hydrochloride and what is the scope of freedom to operate?

Rilpivirine hydrochloride is the generic ingredient in one branded drug marketed by Janssen Prods and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Rilpivirine hydrochloride has two hundred and twenty-two patent family members in forty-one countries.

There are seven drug master file entries for rilpivirine hydrochloride. One supplier is listed for this compound.

Recent Clinical Trials for rilpivirine hydrochloride

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

SponsorPhase
Augusta UniversityPhase 4
Janssen Research & Development, LLCPhase 2
Janssen, LPPhase 1

See all rilpivirine hydrochloride clinical trials

Medical Subject Heading (MeSH) Categories for rilpivirine hydrochloride

US Patents and Regulatory Information for rilpivirine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Prods EDURANT rilpivirine hydrochloride TABLET;ORAL 202022-001 May 20, 2011 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Janssen Prods EDURANT rilpivirine hydrochloride TABLET;ORAL 202022-001 May 20, 2011 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Janssen Prods EDURANT rilpivirine hydrochloride TABLET;ORAL 202022-001 May 20, 2011 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Janssen Prods EDURANT rilpivirine hydrochloride TABLET;ORAL 202022-001 May 20, 2011 RX Yes Yes   Start Trial   Start Trial   Start Trial
Janssen Prods EDURANT rilpivirine hydrochloride TABLET;ORAL 202022-001 May 20, 2011 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Janssen Prods EDURANT rilpivirine hydrochloride TABLET;ORAL 202022-001 May 20, 2011 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for rilpivirine hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1419152 2012C/020 Belgium   Start Trial PRODUCT NAME: RILPIVIRINE; AUTHORISATION NUMBER AND DATE: EU/1/11/736/001 20111130
1419152 C01419152/02 Switzerland   Start Trial PRODUCT NAME: RILPIVIRIN UND TENOFOVIR; REGISTRATION NO/DATE: SWISSMEDIC 62155 12.03.2013
1663240 CA 2016 00064 Denmark   Start Trial PRODUCT NAME: RILPIVIRINHYDROCHLORID, EMTRICITABIN OG TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623
1663240 1690062-3 Sweden   Start Trial PRODUCT NAME: A COMBINATION OF: RILPIVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OF RILPIVIRINE, INCLUDING THE HYDROCHLORIDE SALT OF RILPIVIRINE; EMTRICITABINE; AND TENOFOVIR ALAFENAMIDE, OR A PHARMCEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING TENOFOVIR ALAFENAMIDE FUMARATE.; REG. NO/DATE: EU/1/16/1112 20160623
1419152 PA2012009 Lithuania   Start Trial PRODUCT NAME: EMTRICITABINUM + RILPIVIRINUM + TENOFOVIRUM DISOPROXILUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28 EU/1/11/737/002 20111128
1419152 92001 Luxembourg   Start Trial 92001, EXPIRES: 20261128
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Colorcon
McKinsey
Moodys
McKesson
Harvard Business School

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