INTELENCE Drug Patent Profile

When do Intelence patents expire, and when can generic versions of Intelence launch?

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. Five 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:	120
Clinical Trials:	14
Patent Applications:	4,021
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
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	Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C9 Inhibitors Cytochrome P450 3A Inducers Non-Nucleoside Reverse Transcriptase Inhibitors P-Glycoprotein 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

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	022187-003	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	022187-003	Mar 26, 2012
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-002	Dec 22, 2010

EU/EMA Drug Approvals for INTELENCE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Janssen-Cilag International NV	Intelence	etravirine	EMEA/H/C/000900 Intelence, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is indicated for the treatment of human-immunodeficiency-virus-type-1 (HIV-1) infection in antiretroviral-treatment-experienced adult patients and in antiretroviral-treatment-experienced paediatric patients from six years of age.This indication is based on week-48 analyses from two phase-III trials in highly pretreated patients where Intelence was investigated in combination with an optimised background regimen (OBR) which included darunavir/ritonavir. The indication in paediatric patients is based on 48-week analyses of a single-arm, phase-II trial in antiretroviral-treatment-experienced paediatric patients.	Authorised	no	no	no	2008-08-28

International Patents for INTELENCE

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

Country	Patent Number	Title	Estimated Expiration
Bulgaria	106521
Croatia	P20080359	PIRIMIDINI KOJI INHIBIRAJU REPLIKACIJU HIV-a (HIV REPLICATION INHIBITING PYRIMIDINES)
African Intellectual Property Organization (OAPI)	11675	2,4-Disubstituted triazine derivatives.
Norway	319788
Israel	143024

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	PA2008016	Lithuania		PRODUCT NAME: ETRAVIRINUM; REG. NO/DATE: EU/1/08/468/001 20080828
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	C01002795/01	Switzerland		PRODUCT NAME: ETRAVIRIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58483 13.05.2008
1002795	337	Finland