Details for New Drug Application (NDA): 021976

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NDA 021976 describes PREZISTA, which is a drug marketed by Janssen Prods and is included in two NDAs. It is available from one supplier. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the PREZISTA profile page.

The generic ingredient in PREZISTA is darunavir. There are twenty-five drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the darunavir profile page.

Summary for 021976

Tradename:	PREZISTA
Applicant:	Janssen Prods
Ingredient:	darunavir
Patents:	2

Pharmacology for NDA: 021976

Mechanism of Action	Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors HIV Protease Inhibitors

Suppliers and Packaging for NDA: 021976

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PREZISTA	darunavir	TABLET;ORAL	021976	NDA	Janssen Products LP	59676-562	59676-562-01	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59676-562-01)
PREZISTA	darunavir	TABLET;ORAL	021976	NDA	Janssen Products LP	59676-563	59676-563-01	480 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (59676-563-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jun 23, 2006	TE:		RLD:	Yes
Patent:	⤷ Subscribe	Patent Expiration:	Jun 26, 2027	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Subscribe	Patent Expiration:	Aug 16, 2024	Product Flag?		Substance Flag?		Delist Request?	Y

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	600MG
Approval Date:	Feb 25, 2008	TE:	AB	RLD:	Yes
Patent:	⤷ Subscribe	Patent Expiration:	Jun 26, 2027	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 021976

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-003	Oct 21, 2008	⤷ Subscribe	⤷ Subscribe
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-002	Feb 25, 2008	⤷ Subscribe	⤷ Subscribe
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-001	Jun 23, 2006	⤷ Subscribe	⤷ Subscribe
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-005	Dec 18, 2008	⤷ Subscribe	⤷ Subscribe
Janssen Prods	PREZISTA	darunavir	TABLET;ORAL	021976-002	Feb 25, 2008	⤷ Subscribe	⤷ Subscribe
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