Details for New Drug Application (NDA): 202895

✉ Email this page to a colleague

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:	7,700,645*PED	Patent Expiration:	Jun 26, 2027	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	8,518,987*PED	Patent Expiration:	Aug 16, 2024	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 202895

Subscribe to access the full database, or Subscribe
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Prods	PREZISTA	darunavir	SUSPENSION;ORAL	202895-001	Dec 16, 2011	RE43596*PED	⤷ Subscribe
Janssen Prods	PREZISTA	darunavir	SUSPENSION;ORAL	202895-001	Dec 16, 2011	6,703,403*PED	⤷ Subscribe
Janssen Prods	PREZISTA	darunavir	SUSPENSION;ORAL	202895-001	Dec 16, 2011	RE42889*PED	⤷ Subscribe
Janssen Prods	PREZISTA	darunavir	SUSPENSION;ORAL	202895-001	Dec 16, 2011	5,843,946*PED	⤷ Subscribe
Janssen Prods	PREZISTA	darunavir	SUSPENSION;ORAL	202895-001	Dec 16, 2011	8,518,987*PED	⤷ Subscribe
Janssen Prods	PREZISTA	darunavir	SUSPENSION;ORAL	202895-001	Dec 16, 2011	RE43802*PED	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.