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Serving hundreds of leading biopharmaceutical companies globally:

Merck
McKesson
Express Scripts
Deloitte
Julphar
Chinese Patent Office
Cerilliant
Queensland Health
Moodys

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202022

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NDA 202022 describes EDURANT, which is a drug marketed by Janssen Prods and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the EDURANT profile page.

The generic ingredient in EDURANT is rilpivirine hydrochloride. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the rilpivirine hydrochloride profile page.
Summary for 202022
Tradename:EDURANT
Applicant:Janssen Prods
Ingredient:rilpivirine hydrochloride
Patents:6
Formulation / Manufacturing:see details
Pharmacology for NDA: 202022
Medical Subject Heading (MeSH) Categories for 202022
Suppliers and Packaging for NDA: 202022
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EDURANT rilpivirine hydrochloride TABLET;ORAL 202022 NDA Janssen Products, LP 59676-278 N 59676-278-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:May 20, 2011TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 1, 2021
Regulatory Exclusivity Use:INFORMATION ADDED TO SECTION 8.1 OF THE LABELING REGARDING PREGNANT PATIENTS WHO ARE ALREADY ON A STABLE RILPIVIRINE REGIMEN PRIOR TO PREGNANCY AND WHO ARE VIROLOGICALLY SUPPRESSED (HIV-1 RNA LESS THAN 50 COPIES/ML)
Regulatory Exclusivity Expiration:Aug 26, 2018
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:➤ Sign UpPatent Expiration:Feb 26, 2021Product Flag?YSubstance Flag?YDelist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Merck
Colorcon
Covington
Citi
Chubb
Fuji
Daiichi Sankyo
Fish and Richardson

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