Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Medtronic
Harvard Business School
Mallinckrodt
Merck
Baxter
Johnson and Johnson

Last Updated: December 6, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021976

See Plans and Pricing

« Back to Dashboard

NDA 021976 describes PREZISTA, which is a drug marketed by Janssen Prods and is included in two NDAs. It is available from three suppliers. There are five 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. Three 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:5
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 A-S Medication Solutions 50090-1491 50090-1491-0 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-1491-0)
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)
Paragraph IV (Patent) Challenges for 021976
Tradename Dosage Ingredient NDA Submissiondate
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**Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:Dec 23, 2019Product Flag?Substance Flag?Delist Request?Y
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

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   Start Trial   Start Trial
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-006 Nov 9, 2012   Start Trial   Start Trial
Janssen Prods PREZISTA darunavir TABLET;ORAL 021976-006 Nov 9, 2012   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

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson
AstraZeneca
Moodys
Dow
Boehringer Ingelheim

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 verifification 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.