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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 one Paragraph IV challenge. Additional details are available on the GILENYA profile page.

The generic ingredient in GILENYA is fingolimod. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fingolimod profile page.

Summary for NDA: 022527


Pharmacology for NDA: 022527

Suppliers and Packaging for NDA: 022527

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAPSULE;ORAL 022527 NDA Novartis Pharmaceuticals Corporation 0078-0607 0078-0607-15 30 CAPSULE in 1 BOTTLE (0078-0607-15)
CAPSULE;ORAL 022527 NDA Novartis Pharmaceuticals Corporation 0078-0607 0078-0607-89 7 CAPSULE in 1 CARTON (0078-0607-89)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.5MG
Approval Date:Sep 21, 2010TE:RLD:Yes
Patent:8,324,283Patent Expiration:Mar 29, 2026Product Flag?Substance Flag?Delist Request?
Patent:5,604,229Patent Expiration:Feb 18, 2019Product Flag?Substance Flag?YDelist Request?
Patent:6,004,565Patent Expiration:Sep 23, 2017Product Flag?Substance Flag?Delist Request?

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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.