Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

US Army
Daiichi Sankyo
Federal Trade Commission
Covington
Fish and Richardson
Citi
Cerilliant
Chinese Patent Office
UBS

Generated: January 22, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021976

« 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 four 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 ethanolate. There are twenty-five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the darunavir ethanolate profile page.
Summary for 021976
Tradename:PREZISTA
Applicant:Janssen Prods
Ingredient:darunavir ethanolate
Patents:5
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021976
Suppliers and Packaging for NDA: 021976
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREZISTA darunavir ethanolate TABLET;ORAL 021976 NDA A-S Medication Solutions 50090-1327 50090-1327-0 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-1327-0)
PREZISTA darunavir ethanolate TABLET;ORAL 021976 NDA A-S Medication Solutions 50090-1491 50090-1491-0 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-1491-0)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Jun 23, 2006TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Dec 23, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Sign UpPatent Expiration:Jun 26, 2027Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Sign UpPatent 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 ethanolate TABLET;ORAL 021976-005 Dec 18, 2008 ➤ Sign Up ➤ Sign Up
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-006 Nov 9, 2012 ➤ Sign Up ➤ Sign Up
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-001 Jun 23, 2006 ➤ Sign Up ➤ Sign Up
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-001 Jun 23, 2006 ➤ Sign Up ➤ Sign Up
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-006 Nov 9, 2012 ➤ Sign Up ➤ Sign Up
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-003 Oct 21, 2008 ➤ Sign Up ➤ Sign Up
Janssen Prods PREZISTA darunavir ethanolate TABLET;ORAL 021976-002 Feb 25, 2008 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

This preview shows a limited data set.
Subscribe to access the full database, or try a Free Trial

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Express Scripts
Boehringer Ingelheim
Harvard Business School
Deloitte
Citi
Fuji
Covington
Cipla

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.