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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
McKinsey
Julphar
Farmers Insurance
Cantor Fitzgerald
Merck
Fuji
Fish and Richardson
Teva

Generated: August 15, 2018

DrugPatentWatch Database Preview

EDURANT Drug Profile

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When do Edurant patents expire, and what generic 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 thirteen patent family members in thirty-nine 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.

Drug patent expirations by year for EDURANT
Generic Entry Opportunity Date for EDURANT
Generic Entry Date for EDURANT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Medical Subject Heading (MeSH) Categories for EDURANT
Synonyms for EDURANT
(E)-4-((4-((4-(2-cyanovinyl)-2,6-dimethylphenyl)amino)pyrimidin-2-yl)amino)benzonitrile
(E)-4-(4-(4-(2-cyanovinyl)-2,6-dimethylphenylamino)pyrimidin-2-ylamino)benzonitrile
212WAX8KDD
4-((4-((4-((1E)-2-Cyanoethenyl)-2,6-dimethylphenyl)amino)-2-pyrimidinyl)amino)benzonitrile
4-((4-((4-((1E)-2-Cyanoethenyl)-2,6-dimethylphenyl)amino)pyrimidin-2- yl)amino)benzonitrile
4-[[4-[[4-(2-Cyanoethenyl)-2,6-dimethylphenyl]amino]pyrimidine-2-yl]amino]benzonitrile
4-[[4-[[4-[(E)-2-cyanoethenyl]-2,6-dimethyl-phenyl]amino]pyrimidin-2-yl]amino]benzenecarbonitrile
4-[[4-[[4-[(E)-2-Cyanoethenyl]-2,6-dimethyl-phenyl]amino]pyrimidin-2-yl]amino]benzonitrile
4-[[4-[4-[(E)-2-cyanoethenyl]-2,6-dimethylanilino]-2-pyrimidinyl]amino]benzonitrile
4-[[4-[4-[(E)-2-cyanoethenyl]-2,6-dimethylanilino]pyrimidin-2-yl]amino]benzonitrile
4-[[4-[4-[(E)-2-cyanoethenyl]-2,6-dimethylanilino]pyrimidin-2-yl]amino]benzonitrile;hydrochloride
4-[[4-[4-[(E)-2-cyanovinyl]-2,6-dimethyl-anilino]pyrimidin-2-yl]amino]benzonitrile
4-{[4-({4-[(E)-2-Cyanoethenyl]-2,6-Dimethylphenyl}amino)pyrimidin-2-Yl]amino}benzonitrile
4-{[4-({4-[(E)-2-cyanoethenyl]-2,6-dimethylphenyl}amino)pyrimidin-2-yl]amino}benzonitrile hydrochloride
4-{[4-({4-[(E)-2-cyanovinyl]-2,6-dimethylphenyl}amino)pyrimidin-2-yl]amino}benzonitrile
4-{[4-({4-[(E)-2-cyanovinyl]-2,6-dimethylphenyl}amino)pyrimidin-2-yl]amino}benzonitrile hydrochloride
4-{4-[4-((E)-2-Cyano-vinyl)-2,6-dimethyl-phenylamino]-pyrimidin-2-ylamino}-benzonitrile
500287-72-9
700361-47-3
A827939
AB0027978
AC1O52UT
ACM1312424262
AK402677
AKOS015901680
AKOS025149454
AN-551
AOB87760
API0008127
BC228661
BC677097
BCP0726000192
BCP9000016
BDBM222178
Benzonitrile, 4-((4-((4-((1E)-2-cyanoethenyl)-2,6-dimethylphenyl)amino)-2- pyrimidinyl)amino)-, hydrochloride (1:1)
Benzonitrile, 4-((4-((4-((1E)-2-cyanoethenyl)-2,6-dimethylphenyl)amino)-2-pyrimidinyl)amino)-
Benzonitrile, 4-((4-((4-((1e)-2-cyanoethenyl)-2,6-dimethylphenyl)amino)-2-pyrimidinyl)amino)-, hydrochloride (1:1)
Benzonitrile,4-[[4-[[4-[(1E)-2-cyanoethenyl]-2,6-dimethylphenyl]amino]-2-pyrimidinyl]amino]-
cc-93
CHEBI:68602
CHEBI:68606
CHEMBL1628504
CHEMBL175691
CS-0440
D09720
D09958
D09KSE
D0T6WN
DB08864
DTXSID10198189
DTXSID80220320
Edurant (TN)
Edurant(TM)
Endurant
EX-A245
FI96A8X663
GP3165
HE064867
HE345770
HSDB 8153
HY-10574
I14-14208
KE-0036
KZVVGZKAVZUACK-BJILWQEISA-N
MFCD11046372
MolPort-006-170-051
Mu O-conotoxin
R 278474
R-278474
R278474
Rilpivirine
Rilpivirine (USAN/INN)
Rilpivirine [USAN:INN]
Rilpivirine HCl
Rilpivirine hydrochloride
Rilpivirine hydrochloride (JAN/USAN)
Rilpivirine hydrochloride [USAN]
rilpivirine monohydrochloride
Rilpivirine(R 278474 TMC 278)
RILPIVIRINEHCL
RPV
s7303
SC-44776
SCHEMBL1831067
SCHEMBL384696
SCHEMBL385113
STL484047
TMC 278
TMC-278
TMC-278-LA
TMC278
TMC278 hydrochloride
TMC278-HYDROCHLORIDE
UNII-212WAX8KDD
UNII-FI96A8X663
W-202888
W-5469
W9902
YIBOMRUWOWDFLG-ONEGZZNKSA-N
ZINC1554274

US Patents and Regulatory Information for EDURANT

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

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Non-Orange Book US Patents for 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
7,956,063 Salt of 4-[[4-[[4-(2-cyanoethenyl)-2,6-dimethylphenyl]amino]-2-pyrimidinyl- ]amino]benzonitrile ➤ Try a Free Trial
9,580,392 HIV replication inhibiting pyrimidines ➤ Try a Free Trial
8,841,310 Combinations of a pyrimidine containing NNRTI with RT inhibitors ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for EDURANT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2016 00064 Denmark ➤ Try a Free Trial PRODUCT NAME: RILPIVIRINHYDROCHLORID, EMTRICITABIN OG TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623
C0073 France ➤ Try a Free Trial PRODUCT 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
2015035 Lithuania ➤ Try a Free Trial PRODUCT NAME: RIPALVIRINUM + EMTRICITABINUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28 EU/1/11/737/002 20111128
2015 00056 Denmark ➤ Try a Free Trial PRODUCT NAME: CERTIFIKAT; REG. NO/DATE: EU/1/11/737/001-002 20111128
0767 Netherlands ➤ Try a Free Trial PRODUCT 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, EN TENOFOVIR, IN HET BIJZONDER TENOFOVIRDISOPROXILFUMARAAT; REGISTRATION NO/DATE: EU/1/11/737/001 20111128
2016000111 Germany ➤ Try a Free Trial PRODUCT NAME: KOMBINATION VON RILPIVIRINHYDROCHLORID ODER EINER THERAPEUTISCH AEQUIVALENTEN, DURCH DAS GRUNDPATENT GESCHUETZTEN FORM DAVON, EMTRICITABIN UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621
2016042 Lithuania ➤ Try a Free Trial PRODUCT NAME: RILPIVIRINO HIDROCHLORIDAS + EMTRICITABINAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Fish and Richardson
McKinsey
Moodys
Boehringer Ingelheim
Teva
UBS
Farmers Insurance
Harvard Business School

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