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INTELENCE Drug Profile

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Which patents cover Intelence, and what generic alternatives are available?

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

This drug has fifty-eight patent family members in thirty-five countries.

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

US ANDA Litigation and Generic Entry Outlook for Intelence

Intelence was eligible for patent challenges on January 18, 2012.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 16, 2021. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for INTELENCE

International Patents:	58
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	98
Clinical Trials:	13
Patent Applications:	1,587
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for INTELENCE
DailyMed Link:	INTELENCE at DailyMed

See drug prices for INTELENCE

Generic Entry Opportunity Date for INTELENCE

Constraining patent/regulatory exclusivity:

NEW PATIENT POPULATION

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.

Recent Clinical Trials for INTELENCE

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

Sponsor	Phase
University of Rome Tor Vergata	Phase 2
IRCCS Eugenio Medea	Phase 2
Fundacio Lluita Contra la SIDA	Phase 1

See all INTELENCE clinical trials

Pharmacology for INTELENCE

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

Synonyms for INTELENCE

0C50HW4FO1

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-

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

4-(6-Amino-5-bromo-2-(4-cyanoanilino)pyrimidin-4-yloxy)-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-dimethylphenoxy)pyrimidin-2-yl]amino]-2,3,5,6-tetradeuteriobenzonitrile

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-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

ACM1142096067

ACM1189671484

AK172046

AKOS015896355

AM20080899

API0007220

B-1795

BC004800

BCP03562

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-

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

cyanophenyl)amino]pyrimidin-4-yl}oxy)-3,5-

D04112

DAPY deriv

DB-067700

DB06414

Diaminopyrimidine deriv

DTXSID30181412

EBD13985

Etravine; Etravirine

Etravirine

Etravirine (JAN/USAN/INN)

Etravirine (TMC125)

Etravirine [USAN:INN:BAN:JAN]

Etravirine-d8

etravirine-tmc125

etravirine;

FT-0658058

HE-0088

HMS3651P20

HY-90005

Intelence (TN)

Intelence(TM)

J-513179

MFCD09837879

PB32778

PubChem22565

PYGWGZALEOIKDF-UHFFFAOYSA-N

Q414762

R 165335

R-165335

R165335

R165335-TMC125

R165335;

R165355;

RTX-010809

s3080

SC-44935

SCHEMBL52691

SR-01000944895

SR-01000944895-1

ST1251359

SW219570-1

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
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
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-002	Dec 22, 2010		RX	Yes	Yes					Y
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-001	Jan 18, 2008		RX	Yes	No
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-002	Dec 22, 2010		RX	Yes	Yes

Expired US Patents for INTELENCE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-003	Mar 26, 2012
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-003	Mar 26, 2012
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-001	Jan 18, 2008
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-002	Dec 22, 2010
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-001	Jan 18, 2008
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-003	Mar 26, 2012

International Patents for INTELENCE

Country	Patent Number	Estimated Expiration
Indonesia	28545
Czech Republic	300712
Austria	315031
Germany	122009000003
Argentina	021137
Estonia	200200151

Supplementary Protection Certificates for INTELENCE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1002795	SPC/GB09/003	United Kingdom		SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB09/003 GRANTED TO JANSSEN PHARMACEUTICA NV IN RESPECT OF THE PRODUCT ETRAVIRINE OPTIONALLY IN A FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6342 DATED 08 DECEMBER 2010 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 31 AUGUST 2023.
1002795	91528	Luxembourg		91528, EXPIRES: 20230828
1002795	09C0004	France		PRODUCT NAME: ETRAVIRINE AINSI QUE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/08/468/001 DU 20080828; REGISTRATION NO/DATE AT EEC: EU/1/08/468/001 DU 20080828
1002795	PA2008016	Lithuania		PRODUCT NAME: ETRAVIRINUM; REG. NO/DATE: EU/1/08/468/001 20080828
1002795	PA2008016,C1002795	Lithuania		PRODUCT NAME: ETRAVIRINUM; REGISTRATION NO/DATE: EU/1/08/468/001 20080828
1002795	SPC033/2008	Ireland		SPC033/2008: 20090914, EXPIRES: 20230827