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Serving leading biopharmaceutical companies globally:

Teva
Farmers Insurance
QuintilesIMS
Cipla
Harvard Business School
US Army
Colorcon
Daiichi Sankyo
Dow
Chubb

Generated: December 14, 2017

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Rilpivirine hydrochloride - Generic Drug Details

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

Rilpivirine hydrochloride has two hundred and twelve patent family members in thirty-nine countries and sixty-six supplementary protection certificates in twelve countries.

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

Medical Subject Heading (MeSH) Categories for rilpivirine hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Janssen ProdsEDURANTrilpivirine hydrochlorideTABLET;ORAL202022-001May 20, 2011RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Janssen ProdsEDURANTrilpivirine hydrochlorideTABLET;ORAL202022-001May 20, 2011RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Janssen ProdsEDURANTrilpivirine hydrochlorideTABLET;ORAL202022-001May 20, 2011RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Janssen ProdsEDURANTrilpivirine hydrochlorideTABLET;ORAL202022-001May 20, 2011RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Janssen ProdsEDURANTrilpivirine hydrochlorideTABLET;ORAL202022-001May 20, 2011RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Janssen ProdsEDURANTrilpivirine hydrochlorideTABLET;ORAL202022-001May 20, 2011RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Janssen ProdsEDURANTrilpivirine hydrochlorideTABLET;ORAL202022-001May 20, 2011RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Non-Orange Book Patents for Generic Ingredient: rilpivirine hydrochloride

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
7,956,063Salt of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl- ]amino]benzonitrile► Subscribe
9,580,392HIV replication inhibiting pyrimidines► Subscribe
8,841,310Combinations of a pyrimidine containing NNRTI with RT inhibitors► 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: rilpivirine hydrochloride

Country Document Number Estimated Expiration
South Korea101276571► Subscribe
European Patent Office1278735► Subscribe
Slovenia1419152► Subscribe
New Zealand553323► Subscribe
European Patent Office1789139► Subscribe
Australia2016210733► Subscribe
World Intellectual Property Organization (WIPO)03016306► Subscribe
LithuaniaPA2016042► Subscribe
Brazil0211909► Subscribe
Norway2014030► 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: RILPIVIRINE HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90017-1Sweden► SubscribePRODUCT NAME: RILPIVIRIN OCH FARMACEUTISKT GODTAGBARA ADDITIONSSALTER DAERAV, INBEGRIPET VAETEKLORSYRASALTET AV RILPIVIRIN; REG. NO/DATE: EU/1/11/736/001 20111128
2012 00019Denmark► SubscribePRODUCT NAME: RILPIVIRIN OG FARMACEUTISK ACCEPTABLE ADDITIONSSALTE DERAF, HERUNDER HYDROGENCHLORIDSALTET AF RILPIVIRIN; REG. NO/DATE: EU/1/11/736/001 20111128
2 5010-2012Slovakia► SubscribePRODUCT NAME: RILPIVIRINHYDROCHLORID/TENOFOVIRDIZOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001 - EU/1/11/737/002 20111128
0150039 00166Estonia► SubscribePRODUCT NAME: RILPIVIRIINI (VESINIKKLORIIDSOOLANA) JA EMTRITSITABIINI;REG NO/DATE: EU/1/11/737/001-002 28.11.2011
0851Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN: - RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE; - EMTRICITABINE; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623
2012008,C1419152Lithuania► SubscribePRODUCT NAME: RILPIVIRINUM; REGISTRATION NO/DATE: EU/1/11/736/001 20111128
0150041 00168Estonia► SubscribePRODUCT NAME: RILPIVIRIINI (VESINIKKLORIIDSOOLANA) JA TENOFOVIIR-;REG NO/DATE: EU/1/11/737/001-002 28.11.2011
2012000035Germany► SubscribePRODUCT NAME: RILPIVIRIN UND DESSEN STEREOCHEMISCH ISOMERE FORMEN, SOWIE DESSEN PHARMAZEUTISCH UNBEDENKLICHE ADDITIONSSALZE, EINSCHLIESSLICH DES CHLORWASSERSTOFFSAEURESALZES VON RILPIVIRIN; REGISTRATION NO/DATE: EU/1/11/736/001 20111128
C0036France► SubscribePRODUCT NAME: COMBINAISON DE RILPIVIRINE ET TOUTES SES FORMES THERAPEUTIQUEMENT EQUIVALENTES PROTEGEES PAR LE BREVET DE BASE, TELLES QUE LES SELS D'ADDITION PHARMACEUTIQUEMENT ACCEPTABLES DE RILPIVIRINE, Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE ET DE TENOFOVIR, EN PARTICULIER LE TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/11/737/001 20111128
2012 00021Denmark► SubscribePRODUCT NAME: KOMBINATION AF RILPIVIRIN ELLER ET FARMACEUTISK ACCEPTABELT ADDITIONSSALT AF RILPIVIRIN, HERUNDER HYDROCHLORID ADDITIONSSALTET AF RILPIVIRIN, OG TENOFOVIR, NAVNLIG TENOFOVIRDISOPROXILFUMARAT; REG. NO/DATE: EU/1/11/737/001-002 20111128
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Serving leading biopharmaceutical companies globally:

Fuji
Cantor Fitzgerald
Argus Health
Queensland Health
Johnson and Johnson
QuintilesIMS
Merck
Chubb
Daiichi Sankyo
McKesson

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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