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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
Deloitte
Fuji
AstraZeneca
Colorcon
Healthtrust
Cantor Fitzgerald
Covington
US Department of Justice

Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022527

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NDA 022527 describes GILENYA, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the GILENYA profile page.

The generic ingredient in GILENYA is fingolimod hydrochloride. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fingolimod hydrochloride profile page.
Summary for 022527
Tradename:GILENYA
Applicant:Novartis
Ingredient:fingolimod hydrochloride
Patents:3
Formulation / Manufacturing:see details
Pharmacology for NDA: 022527
Suppliers and Packaging for NDA: 022527
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527 NDA Novartis Pharmaceuticals Corporation 0078-0607 N 0078-0607-15
GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527 NDA Novartis Pharmaceuticals Corporation 0078-0607 N 0078-0607-89

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 0.5MG BASE
Approval Date:Sep 21, 2010TE:RLD:Yes
Regulatory Exclusivity Expiration:May 11, 2021
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Nov 11, 2021
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:➤ Sign UpPatent Expiration:Aug 18, 2019Product Flag?Substance Flag?Delist Request?Y

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
QuintilesIMS
Fuji
Deloitte
Merck
UBS
Fish and Richardson
Covington
AstraZeneca

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