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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Baxter
Argus Health
Julphar
McKinsey
Merck
Cerilliant
Healthtrust
Fish and Richardson

Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202895

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NDA 202895 describes PREZISTA, which is a drug marketed by Janssen Prods and is included in two NDAs. It is available from six 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. Six suppliers are listed for this compound. Additional details are available on the darunavir ethanolate profile page.
Summary for 202895
Tradename:PREZISTA
Applicant:Janssen Prods
Ingredient:darunavir ethanolate
Patents:5
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 202895
Suppliers and Packaging for NDA: 202895
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PREZISTA darunavir ethanolate SUSPENSION;ORAL 202895 NDA Janssen Products LP 59676-565 N 59676-565-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrengthEQ 100MG BASE/ML
Approval Date:Dec 16, 2011TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Dec 23, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Try a Free TrialPatent Expiration:Jun 26, 2027Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Try a Free TrialPatent Expiration:Aug 16, 2024Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 202895

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Prods PREZISTA darunavir ethanolate SUSPENSION;ORAL 202895-001 Dec 16, 2011 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Prods PREZISTA darunavir ethanolate SUSPENSION;ORAL 202895-001 Dec 16, 2011 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Prods PREZISTA darunavir ethanolate SUSPENSION;ORAL 202895-001 Dec 16, 2011 ➤ Try a Free Trial ➤ Try a Free Trial
Janssen Prods PREZISTA darunavir ethanolate SUSPENSION;ORAL 202895-001 Dec 16, 2011 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Federal Trade Commission
US Army
US Department of Justice
Medtronic
Daiichi Sankyo
Chubb
Fuji
Johnson and Johnson

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