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Serving leading biopharmaceutical companies globally:

Deloitte
Moodys
Covington
Cipla
Citi
Farmers Insurance
Daiichi Sankyo
US Army
Accenture
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Generated: October 23, 2017

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EDURANT Drug Profile

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What is the patent landscape for Edurant, and what generic Edurant alternatives are available?

Edurant is a drug marketed by Janssen Prods and is included in one NDA. There are six patents protecting this drug.

This drug has two hundred and sixteen patent family members in thirty-nine countries and sixty-six supplementary protection certificates in twelve countries.

The generic ingredient in EDURANT is rilpivirine hydrochloride. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the rilpivirine hydrochloride profile page.

Summary for Tradename: EDURANT

US Patents:6
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list60
Clinical Trials: see list9
Patent Applications: see list7
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:EDURANT 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► 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► 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► 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► Subscribe► Subscribe
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Non-Orange Book Patents for Tradename: EDURANT

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 Tradename: EDURANT

Country Document Number Estimated Expiration
HungaryS1500053► Subscribe
Japan2008511592► Subscribe
Hong Kong1145449► Subscribe
China101056673► Subscribe
Norway339788► Subscribe
Hong Kong1070066► Subscribe
Austria472537► Subscribe
China1220684► Subscribe
South Korea101284361► Subscribe
Spain2371442► 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: EDURANT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
2015035Lithuania► SubscribePRODUCT NAME: RIPALVIRINUM + EMTRICITABINUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28 EU/1/11/737/002 20111128
2015 00055Denmark► SubscribePRODUCT NAME: KOMBINATION AF RILPIVIRIN ELLER EN TERAPEUTISK AEKVIVALENT FORM DERAF, SOM ER BESKYTTET AF GRUNDPATENTET, SASOM ET FARMECEUTISK ACCEPTABELT SALT AF RILPIVIRIN, HERUNDER HYDROCHLORIDSALTET AF RILPIVIRIN, TENOFOVIR, NAVNLIG TENOFOVIRDISOPROXILFUMARAT; REG. NO/DATE: EU/1/11/737/001-002 20111128
001Luxembourg► Subscribe92001, EXPIRES: 20261128
2012008Lithuania► SubscribePRODUCT NAME: RILPIVIRINUM; REGISTRATION NO/DATE: EU/1/11/736/001 20111128
0150040 00167Estonia► SubscribePRODUCT NAME: RILPIVIRIINI (VESINIKKLORIIDSOOLANA), TENOFOVIIR-;REG NO/DATE: EU/1/11/737/001-002 28.11.2011
2016044Lithuania► SubscribePRODUCT NAME: RILPIVIRINAS + EMTRICITABINAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621
C0073France► SubscribePRODUCT NAME: COMBINAISON DE RILPIVIRINE OU SES FORMES THERAPEUTIQUEMENT EQUIVALENTES PROTEGEES PAR LE BREVET DE BASE TELLES QUE LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE RILPIVIRINE Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE DE TENOFOVIR EN PARTICULIER LE TENOFOVIR DISOPROXIL FUMARATE AINSI QUE D'EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
0768Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN DIE BESCHERMD WORDT DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE. TENOFOVIR, IN HET BIJZONDER TENOFOVIRDISOPROXILFUMARAAT. EN EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
2012000038Germany► SubscribePRODUCT NAME: KOMBINATION AUS RILPIVIRIN ODER EINER STEREOCHEMISCH ISOMEREN FORM ODER EINEM PHARMAZEUTISCH UNBEDENKLICHEN ADDITIONSSALZ DESSELBEN, EINSCHLIESSLICH DES CHLORWASSERSTOFFSAEURESALZES VON RILPIVIRIN, UND TENOFOVIR, INSBESONDERE TENOFOVIRDISOPROXILFUMARAT.; REGISTRATION NO/DATE: EU/1/11/737/001 20111128
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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Deloitte
UBS
Argus Health
Dow
Mallinckrodt
Moodys
Colorcon
Chubb
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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