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Last Updated: July 3, 2020

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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 two suppliers. 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. Two 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
Formulation / Manufacturing:see details
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)
Paragraph IV (Patent) Challenges for 021976
Tradename Dosage Ingredient NDA Submissiondate
PREZISTA TABLET;ORAL darunavir 021976 2013-05-14
PREZISTA TABLET;ORAL darunavir 021976 2010-06-23

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jun 23, 2006TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jun 26, 2027Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:Aug 16, 2024Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Feb 25, 2008TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Jun 26, 2027Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 021976

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-001 Jun 23, 2006   Start Trial   Start Trial
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-005 Dec 18, 2008   Start Trial   Start Trial
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-005 Dec 18, 2008   Start Trial   Start Trial
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-002 Feb 25, 2008   Start Trial   Start Trial
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-003 Oct 21, 2008   Start Trial   Start Trial
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-003 Oct 21, 2008   Start Trial   Start Trial
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-006 Nov 9, 2012   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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