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Profile for Tradename: GILENYA

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Gilenya 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.

This drug has ninety-six patent family members in thirty-nine countries.

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 Tradename: GILENYA

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
2013 Sales:$1,059,346,000

Pharmacology for Tradename: GILENYA

Clinical Trials for: GILENYA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
GILENYA
fingolimod
CAPSULE;ORAL022527-001Sep 21, 2010RXYes6,004,565<disabled><disabled>
Novartis
GILENYA
fingolimod
CAPSULE;ORAL022527-001Sep 21, 2010RXYes<disabled><disabled>
Novartis
GILENYA
fingolimod
CAPSULE;ORAL022527-001Sep 21, 2010RXYes5,604,229<disabled>Y<disabled>
Novartis
GILENYA
fingolimod
CAPSULE;ORAL022527-001Sep 21, 2010RXYes8,324,283<disabled><disabled>
Novartis
GILENYA
fingolimod
CAPSULE;ORAL022527-001Sep 21, 2010RXYes<disabled><disabled>
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Paragraph IV activity for: GILENYA

Drugname Dosage Strength RLD Submissiondate
fingolimodCapsules0.5 mgGilenya9/22/2014

International Patent Family for Tradename: GILENYA

Country Document Number Publication Date
Peru02002013Mar 09, 2013
Germany602004017847Jan 02, 2009
Australia2004228929Feb 07, 2008
BrazilPI0409250Mar 28, 2006
Japan2004307506Nov 04, 2004
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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