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INTELENCE Drug Profile

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When do Intelence patents expire, and what generic alternatives are available?

Intelence is a drug marketed by Janssen R And D and is included in one NDA. There are four patents protecting this drug.

This drug has one hundred and forty-three patent family members in thirty-nine countries.

The generic ingredient in INTELENCE is etravirine. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the etravirine profile page.

Summary for INTELENCE

International Patents:	143
US Patents:	4
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	80
Clinical Trials:	12
Patent Applications:	1,288
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for INTELENCE
DailyMed Link:	INTELENCE at DailyMed

Generic Entry Opportunity Date for INTELENCE

NDA:

022187

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.

Pharmacology for INTELENCE

Ingredient-type	Non-Nucleoside Analog
Drug Class	Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Non-Nucleoside Reverse Transcriptase Inhibitors

Synonyms for INTELENCE

0C50HW4FO1

1142096-06-7

269055-15-4

394729-17-0

3m8p

4-((6-amino-5-bromo-2-((4-cyanophenyl) amino) pyrimidin-4-yl) oxy)-3, 5-dimethylbenzonitrile

4-((6-amino-5-bromo-2-((4-cyanophenyl)amino)-4-pyrimidinyl)oxy)-3,5-dimethyl-benzonitrile

4-((6-Amino-5-bromo-2-((4-cyanophenyl)amino)pyrimidin-4-yl)oxy)-3,5-dimethylbenzonitrile

4-({6-AMINO-5-BROMO-2-[(4-CYANOPHENYL)AMINO]PYRIMIDIN-4-YL}OXY)-3,5-DIMETHYLBENZONITRILE

4-(6-amino-5-bromo-2-(4-cyanophenylamino)pyrimidin-4-ylamino)-3,5-dimethylbenzonitrile

4-(6-amino-5-bromo-2-(4-cyanophenylamino)pyrimidin-4-yloxy)-3,5-dimethylbenzonitrile

4-[[4-amino 5-bromo-6-(4-cyano-2,6-dimethylphenyloxy)-2-pyrimidinyl]amino]benzonitrile

4-[[4-amino-5-bromo-6-(4-cyano-2,6-dimethylphenyloxy)-2-pyrimidinyl]-amino]benzonitrile

4-[[4-amino-5-bromo-6-(4-cyano-2,6-dimethylphenyloxy)-2-pyrimidinyl]amino]-benzonitrile

4-[[4-amino-5-bromo-6-(4-cyano-2,6-dimethylphenyloxy)-2-pyrimidinyl]amino]-benzonitrile;

4-[[4-amino-5-bromo-6-(4-cyano-2,6-dimethylphenyloxy)-2-pyrimidinyl]amino]benzonitrile

4-[[6-amino-5-bromo-2-(4-cyanoanilino)-4-pyrimidinyl]oxy]-3,5-dimethylbenzonitrile

4-[[6-amino-5-bromo-2-[(4-cyanophenyl)amino]-4-pyrimidinyl]oxy]-3, 5 Cdimethylbenzonitrile

4-[[6-amino-5-bromo-2-[(4-cyanophenyl)amino]-4-pyrimidinyl]oxy]-3,5-dimethyl benzonitrile

4-[[6-AMINO-5-BROMO-2-[(4-CYANOPHENYL)AMINO]-4-PYRIMIDINYL]OXY]-3,5-DIMETHYLBENZONITRILE

4-[6-amino-5-bromo-2-(4-cyano-phenylamino)-pyrimidin-4-yloxy]-3,5-dimethyl-benzonitrile

4-[6-amino-5-bromo-2-(4-cyanoanilino)pyrimidin-4-yl]oxy-3,5-dimethyl-benzonitrile

4-[6-amino-5-bromo-2-(4-cyanoanilino)pyrimidin-4-yl]oxy-3,5-dimethylbenzonitrile

4-[6-amino-5-bromo-2-[ amino]pyrimidin-4-yl]oxy-3,5-dimethyl-benzonitrile

4-[6-AMINO-5-BROMO-2-[(4-CYANOPHENYL)AMINO]PYRIMIDIN-4-YL]OXY-3,5-DIMETHYL-BENZONITRILE

4-[6-azanyl-5-bromanyl-2-[(4-cyanophenyl)amino]pyrimidin-4-yl]oxy-3,5-dimethyl-benzenecarbonitrile

4CA-0516

65B

A818671

AB0030712

AB01566873_01

ABP001081

AC-8503

AC1L4XC5

ACM1142096067

ACM1189671484

AK172046

AKOS015896355

AM20080899

AN-6704

API0007220

B-1795

BC004800

BC228657

BCP0726000193

BCP9000006

BDBM50103642

Benzonitrile, 4-((6-amino-5-bromo-2-((4-cyanophenyl)amino)-4-pyrimidinyl)oxy)-3,5-dimethyl-

Benzonitrile, 4-[[6-amino-5-bromo-2-[(4-cyanophenyl)amino]-4-pyrimidinyl]oxy]-3,5-dimethyl-

C20H15BrN6O

cc-89

CHEBI:63589

CHEMBL308954

CM14420

CS-0435

CTK4I1392

D04112

D0BP9C

DAPY deriv

DB-067700

DB06414

Diaminopyrimidine deriv

DTXSID30181412

EBD13985

etravirin

Etravirine

Etravirine (JAN/USAN/INN)

Etravirine (TMC125)

Etravirine-d8

etravirine;

FT-0658058

HE-0088

HE068441

HE330415

HMS3651P20

HY-90005

I06-1887

Intelence (TN)

Intelence(TM)

J-513179

KB-51834

MFCD09837879

MolPort-009-194-145

PB32778

PL052624

PubChem22565

PYGWGZALEOIKDF-UHFFFAOYSA-N

R 165335

R-165335

R165335

R165335-TMC125

R165335;

R165355;

RP17742

RTX-010809

s3080

SC-44935

SCHEMBL52691

SR-01000944895

SR-01000944895-1

ST1251359

ST51053273

TMC 125

TMC 125;

TMC-125

TMC-125;

TMC-125/R-165335

TMC125

UNII-0C50HW4FO1

X2931

ZINC602632

US Patents and Regulatory Information for INTELENCE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-003	Mar 26, 2012		RX	Yes	No					Y
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-001	Jan 18, 2008		RX	Yes	No					Y
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-003	Mar 26, 2012		RX	Yes	No					Y

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Non-Orange Book US Patents for INTELENCE

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
8,530,655	HIV replication inhibiting pyrimidines
6,638,932	2,4-disubstituted triazine derivatives
7,015,221	2,4-disubstituted triazine derivatives

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International Patents for INTELENCE

Country	Document Number	Estimated Expiration
Australia	1046200
Croatia	P20010161
Taiwan	541305

Supplementary Protection Certificates for INTELENCE

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2009 00004	Denmark
2008016,C1002795	Lithuania		PRODUCT NAME: ETRAVIRINUM; REGISTRATION NO/DATE: EU/1/08/468/001 20080828
528	Luxembourg		91528, EXPIRES: 20230828