Details for New Drug Application (NDA): 022187

NDA 022187 describes INTELENCE, which is a drug marketed by Janssen R And D and is included in one NDA. It is available from two suppliers. Additional details are available on the INTELENCE profile page.

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

Summary for 022187

Tradename:	INTELENCE
Applicant:	Janssen R And D
Ingredient:	etravirine
Patents:	0

Pharmacology for NDA: 022187

Mechanism of Action

Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C9 Inhibitors Cytochrome P450 3A Inducers Non-Nucleoside Reverse Transcriptase Inhibitors P-Glycoprotein Inhibitors

Suppliers and Packaging for NDA: 022187

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
INTELENCE	etravirine	TABLET;ORAL	022187	NDA	Patriot Pharmaceuticals	10147-0570	10147-0570-1	120 TABLET in 1 BOTTLE, PLASTIC (10147-0570-1)
INTELENCE	etravirine	TABLET;ORAL	022187	NDA	Patriot Pharmaceuticals	10147-0571	10147-0571-1	60 TABLET in 1 BOTTLE, PLASTIC (10147-0571-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Jan 18, 2008	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Dec 22, 2010	TE:	AB	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	25MG
Approval Date:	Mar 26, 2012	TE:		RLD:	Yes

Expired US Patents for NDA 022187

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	022187-001	Jan 18, 2008
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-002	Dec 22, 2010
Janssen R And D	INTELENCE	etravirine	TABLET;ORAL	022187-003	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

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