Details for New Drug Application (NDA): 202895

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NDA 202895 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 202895

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

Pharmacology for NDA: 202895

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

Suppliers and Packaging for NDA: 202895

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PREZISTA	darunavir	SUSPENSION;ORAL	202895	NDA	Janssen Products LP	59676-565	59676-565-01	1 BOTTLE, GLASS in 1 CARTON (59676-565-01) / 200 mL in 1 BOTTLE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION;ORAL			Strength	100MG/ML
Approval Date:	Dec 16, 2011	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Jun 26, 2027	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	⤷ Sign Up	Patent Expiration:	Aug 16, 2024	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 202895

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	PREZISTA	darunavir	SUSPENSION;ORAL	202895-001	Dec 16, 2011	⤷ Sign Up	⤷ Sign Up
Janssen Prods	PREZISTA	darunavir	SUSPENSION;ORAL	202895-001	Dec 16, 2011	⤷ Sign Up	⤷ Sign Up
Janssen Prods	PREZISTA	darunavir	SUSPENSION;ORAL	202895-001	Dec 16, 2011	⤷ Sign Up	⤷ Sign Up
Janssen Prods	PREZISTA	darunavir	SUSPENSION;ORAL	202895-001	Dec 16, 2011	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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