Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Novartis
Boehringer Ingelheim
UBS
Merck
Cantor Fitzgerald
Accenture
Daiichi Sankyo
Teva
Baxter

Generated: December 10, 2017

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 five suppliers. There are nine 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-four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the darunavir ethanolate profile page.

Summary for 021976

Tradename:1
Applicant:1
Ingredient:1
Patents:9
Therapeutic Class:Antivirals
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 REMEDYREPACK INC. 52125-613 52125-613-02 30 TABLET, FILM COATED in 1 BLISTER PACK (52125-613-02)
PREZISTA darunavir ethanolate TABLET;ORAL 021976 NDA State of Florida DOH Central Pharmacy 53808-0672 53808-0672-1 30 TABLET, FILM COATED in 1 BLISTER PACK (53808-0672-1)

Summary 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300MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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
Regulatory Exclusivity Expiration:Aug 1, 2016
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:► SubscribePatent Expiration:Dec 26, 2016Product Flag?Substance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Dec 26, 2016Product Flag?Substance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021976

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen ProdsPREZISTAdarunavir ethanolateTABLET;ORAL021976-006Nov 9, 2012► Subscribe► Subscribe
Janssen ProdsPREZISTAdarunavir ethanolateTABLET;ORAL021976-003Oct 21, 2008► Subscribe► Subscribe
Janssen ProdsPREZISTAdarunavir ethanolateTABLET;ORAL021976-003Oct 21, 2008► Subscribe► Subscribe
Janssen ProdsPREZISTAdarunavir ethanolateTABLET;ORAL021976-003Oct 21, 2008► Subscribe► Subscribe
Janssen ProdsPREZISTAdarunavir ethanolateTABLET;ORAL021976-003Oct 21, 2008► Subscribe► Subscribe
Janssen ProdsPREZISTAdarunavir ethanolateTABLET;ORAL021976-003Oct 21, 2008► Subscribe► Subscribe
Janssen ProdsPREZISTAdarunavir ethanolateTABLET;ORAL021976-004Dec 18, 2008► Subscribe► Subscribe
Janssen ProdsPREZISTAdarunavir ethanolateTABLET;ORAL021976-001Jun 23, 2006► Subscribe► Subscribe
Janssen ProdsPREZISTAdarunavir ethanolateTABLET;ORAL021976-001Jun 23, 2006► Subscribe► Subscribe
Janssen ProdsPREZISTAdarunavir ethanolateTABLET;ORAL021976-004Dec 18, 2008► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.



Complete Access Available with Subscription
« Back to Dashboard

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

Serving leading biopharmaceutical companies globally:

Merck
Cantor Fitzgerald
Healthtrust
AstraZeneca
Medtronic
Argus Health
Chinese Patent Office
Teva
Cerilliant
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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot