INTELENCE Drug Patent Profile

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.

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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Intelence

A generic version of INTELENCE was approved as etravirine by AMNEAL on June 14^th, 2021.

Summary for INTELENCE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	14
Patent Applications:	1,995
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for INTELENCE
What excipients (inactive ingredients) are in INTELENCE?	INTELENCE excipients list
DailyMed Link:	INTELENCE at DailyMed

See drug prices for INTELENCE

Recent Clinical Trials for INTELENCE

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

Sponsor	Phase
IRCCS Eugenio Medea	Phase 2
University of Rome Tor Vergata	Phase 2
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia	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

Anatomical Therapeutic Chemical (ATC) Classes for INTELENCE

J05AG	Non-nucleoside reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for INTELENCE

INTELENCE is protected by zero US patents and one FDA Regulatory Exclusivity.

FDA Regulatory Exclusivity protecting 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	AB	RX	Yes	No
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-002	Dec 22, 2010	AB	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	022187-002	Dec 22, 2010
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	022187-003	Mar 26, 2012
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-001	Jan 18, 2008
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-003	Mar 26, 2012
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-002	Dec 22, 2010

International Patents for INTELENCE

See the table below for patents covering INTELENCE around the world.

Country	Patent Number	Title	Estimated Expiration
Netherlands	300373
Poland	348145
Portugal	1129079
Czech Republic	20011533
African Intellectual Property Organization (OAPI)	11674	HIV Replication inhibiting pyrimidines.
Taiwan	541305
Eurasian Patent Organization	200100536

Supplementary Protection Certificates for INTELENCE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1002795	300373	Netherlands		300373, 20191101, EXPIRES: 20230827
1002795	PA2008016,C1002795	Lithuania		PRODUCT NAME: ETRAVIRINUM; REGISTRATION NO/DATE: EU/1/08/468/001 20080828
1002795	CA 2009 00004	Denmark
1002795	C01002795/01	Switzerland		PRODUCT NAME: ETRAVIRIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58483 13.05.2008
1002795	SZ 5/2009	Austria		PRODUCT NAME: ETRAVIRIN UND DESSEN ADDITIONSSALZE
1002795	337	Finland
1002795	91528	Luxembourg		91528, EXPIRES: 20230828