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Generated: June 18, 2019

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 four patents protecting this drug and two Paragraph IV challenges. Additional details are available on the GILENYA profile page.

The generic ingredient in GILENYA is fingolimod hydrochloride. There are twenty-one 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
Ingredient:fingolimod hydrochloride
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 022527
Generic Entry Date for 022527*:
Constraining patent/regulatory exclusivity:

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 022527
Medical Subject Heading (MeSH) Categories for 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 0078-0607-15 30 CAPSULE in 1 BOTTLE (0078-0607-15)
GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527 NDA Novartis Pharmaceuticals Corporation 0078-0607 0078-0607-89 7 CAPSULE in 1 CARTON (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:➤ Try a Free TrialPatent Expiration:Aug 18, 2019Product Flag?Substance Flag?Delist Request?Y

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