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Serving leading biopharmaceutical companies globally:

Dow
Merck
Julphar
UBS
Teva
US Department of Justice
Covington
Mallinckrodt
Citi
Queensland Health

Generated: February 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. 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 022527
Tradename:GILENYA
Applicant:Novartis
Ingredient:fingolimod
Patents:3
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 CAPSULE;ORAL 022527 NDA Novartis Pharmaceuticals Corporation 0078-0607 N 0078-0607-89
GILENYA fingolimod CAPSULE;ORAL 022527 NDA Novartis Pharmaceuticals Corporation 0078-0607 N 0078-0607-15

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength0.5MG
Approval Date:Sep 21, 2010TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Feb 18, 2019Product Flag?Substance Flag?YDelist Request?
Patented Use:TREATMENT OF AUTOIMMUNE DISEASE
Patent:➤ Sign UpPatent Expiration:Mar 29, 2026Product Flag?Substance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Jun 25, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF AUTOIMMUNE DISEASE

Expired US Patents for NDA 022527

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis GILENYA fingolimod CAPSULE;ORAL 022527-001 Sep 21, 2010 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Harvard Business School
McKesson
Julphar
McKinsey
Colorcon
Express Scripts
UBS
US Department of Justice

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