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Serving leading biopharmaceutical companies globally:

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Generated: October 19, 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 sixteen 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.

Summary for Generic Name: rilpivirine hydrochloride

US Patents:6
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: see list7
Suppliers / Packagers: see list1
Bulk Api Vendors: see list4
Clinical Trials: see list2,335
Patent Applications: see list13
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:rilpivirine hydrochloride at DailyMed
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;ORAL202022-001May 20, 2011RXYesYes► Subscribe► Subscribe► Subscribe
Janssen Prods
EDURANT
rilpivirine hydrochloride
TABLET;ORAL202022-001May 20, 2011RXYesYes► Subscribe► SubscribeYY ► Subscribe
Janssen Prods
EDURANT
rilpivirine hydrochloride
TABLET;ORAL202022-001May 20, 2011RXYesYes► Subscribe► SubscribeYY ► Subscribe
Janssen Prods
EDURANT
rilpivirine hydrochloride
TABLET;ORAL202022-001May 20, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
Janssen Prods
EDURANT
rilpivirine hydrochloride
TABLET;ORAL202022-001May 20, 2011RXYesYes► Subscribe► SubscribeYY ► Subscribe
Janssen Prods
EDURANT
rilpivirine hydrochloride
TABLET;ORAL202022-001May 20, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
Janssen Prods
EDURANT
rilpivirine hydrochloride
TABLET;ORAL202022-001May 20, 2011RXYesYes► Subscribe► SubscribeYY ► 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
Spain2368996► Subscribe
CroatiaP20120499► Subscribe
Norway20024126► Subscribe
Denmark1632232► Subscribe
South Africa200206192► Subscribe
African Regional IP Organization (ARIPO)2109► Subscribe
South Korea100855258► Subscribe
Cyprus1116565► Subscribe
South Africa200401159► Subscribe
Argentina036387► 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
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
C0035France► SubscribePRODUCT NAME: RILPIVIRINE AINSI QUE SES FORMES THERAPEUTIQUEMENT PROTEGEES PAR LE BREVET DE BASE, TELLES QUE LES SELS D'ADDITION DE RILPIVIRINE PHARMACEUTIQUEMENT ACCEPTABLES, Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE; REGISTRATION 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
2015 00054Denmark► SubscribePRODUCT NAME: KOMBINATION AF RILPIVIRIN ELLER ETN TERAPEUTISK AEKVIVALENT FORM DERAF, SOM ER BESKYTTET AF GRUNDPATENTET, SASOM ET FARMACEUTISK ACCEPTABELT SALT AF RILPIVIRIN, HERUNDER HYDROCHLORIDSALTET AF RILPIVIRIN, OG EMTRICITABIN; REG. NO/DATE: EU/1/11/737/001-002 20111128
2012008Lithuania► SubscribePRODUCT NAME: RILPIVIRINUM; REGISTRATION NO/DATE: EU/1/11/736/001 20111128
2016042Lithuania► SubscribePRODUCT NAME: RILPIVIRINO HIDROCHLORIDAS + EMTRICITABINAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621
0120010 00057Estonia► SubscribePRODUCT NAME: EDURANT - RILPIVIRIIN;REG NO/DATE: C(2011)8955 FINAL 28.11.2011
3 5021-2015Slovakia► SubscribePRODUCT NAME: EMTRICITABIN/RILPIVIRINHYDROCHLORID/TENOFOVIRDIZOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001 - EU/1/11/737/002 20111128
2015000085Germany► SubscribePRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN FORM DAVON, DIE DURCH DAS GRUNDPATENT GESCHUETZT IST, WIE Z.B EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, UND EMTRICITABIN; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
2015000088Germany► SubscribePRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN FORM DAVON, DIE DURCH DAS GRUNDPATENT GESCHUETZT IST, WIE Z.B EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN, TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT, UND EMTRICITABIN; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Chinese Patent Office
Citi
AstraZeneca
Merck
Express Scripts
Farmers Insurance
McKesson
Covington
Johnson and Johnson

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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