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Last Updated: April 24, 2024

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. Ten 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)

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**Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jun 23, 2006TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Jun 26, 2027Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Try a 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:⤷  Try a 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 021976-006 Nov 9, 2012 ⤷  Try a Trial ⤷  Try a Trial
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-003 Oct 21, 2008 ⤷  Try a Trial ⤷  Try a Trial
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-001 Jun 23, 2006 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.