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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: see list1
2013 Sales:$1,059,346,000

Pharmacology for Tradename: GILENYA

Clinical Trials for: GILENYA

Biologic Basis for Multiple Sclerosis Disease Progression in RRMS Patients Treated With Gilenya
Status: Recruiting Condition: Multiple Sclerosis-Relapsing-Remitting

Gilenya in Amyotrophic Lateral Sclerosis (ALS)
Status: Active, not recruiting Condition: Amyotrophic Lateral Sclerosis

Evaluation of the Autonomic Nervous System During First-dosing With 0.5mg of Fingolimod (Gilenya) in Patients With Relapsing-remitting MS
Status: Recruiting Condition: Multiple Sclerosis; Autonomic Nervous System Dysfunction

Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
Status: Completed Condition: Multiple Sclerosis

Long-term Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
Status: Completed Condition: Multiple Sclerosis

Study to Assess Immune Function and MRI Disease Activity in RRMS Patients When Switching From Natalizumab to Gilenya
Status: Recruiting Condition: Relapsing Remitting Multiple Sclerosis

Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab to Fingolimod
Status: Terminated Condition: Relapsing Remitting Multiple Sclerosis (RRMS)

An Extension Study of the Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing Multiple Sclerosis
Status: Completed Condition: Multiple Sclerosis

Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase
Status: Completed Condition: Multiple Sclerosis

Assessing Induction of Type II (M2) Monocytes/Macrophages in Patients Receiving Gilenya.
Status: Recruiting Condition: Multiple Sclerosis

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
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
Japan2011006461Jan 13, 2011
Germany102004016947Oct 21, 2004
European Patent Office2319502May 11, 2011
China1767819May 03, 2006
Russian Federation2005134173Sep 10, 2006
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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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