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Last Updated: October 23, 2019

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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 seventeen patent family members in forty 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
Drug Prices for EDURANT

See drug prices 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.

Recent Clinical Trials for EDURANT

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

SponsorPhase
National Institute of Allergy and Infectious Diseases (NIAID)Phase 1/Phase 2
Johnson & Johnson Pte LtdPhase 3
University of NebraskaPhase 2

See all EDURANT clinical trials

Recent Litigation for EDURANT

Identify potential future generic entrants

District Court Litigation
Case NameDate
Janssen Pharmaceutica, N v. v. Mylan Pharmaceuticals, Inc.2015-09-02
Janssen Pharmaceutica, N v. v. Mylan Pharmaceuticals, Inc.2015-08-31

See all EDURANT litigation

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
BCP03563
BCP0726000192
BCP13350
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
DB08864
DTXSID10198189
DTXSID80220320
Edurant (TN)
Edurant(TM)
Endurant
EX-A245
FI96A8X663
GP3165
HSDB 8153
HY-10574
I14-14208
KE-0036
KZVVGZKAVZUACK-BJILWQEISA-N
MolPort-006-170-051
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)
RPV
s7303
SB19133
SB19134
SC-44776
SCHEMBL1831067
SCHEMBL384696
SCHEMBL385113
STL484047
SW220232-1
T27
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   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 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 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 EDURANT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1419152 12C0036 France   Start Trial PRODUCT 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
1663240 PA2015035 Lithuania   Start Trial PRODUCT NAME: RIPALVIRINUM + EMTRICITABINUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28 EU/1/11/737/002 20111128
1663240 CA 2015 00055 Denmark   Start Trial PRODUCT 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
1419152 92001 Luxembourg   Start Trial 92001, EXPIRES: 20261128
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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