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Details for Generic Name: fingolimod

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Fingolimod is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has ninety-seven patent family members in thirty-nine countries.

There are eighteen drug master file entries for fingolimod. One supplier is listed for this compound.

Summary for Generic Name: fingolimod

Tradenames:1
Patents:3
Applicants:1
NDAs:1
Drug Master File Entries: see list18
Suppliers / Packaging: see list3

Pharmacology for Ingredient: fingolimod

Clinical Trials for: fingolimod

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)

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

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

Safety and Efficacy of Fingolimod in MS Patients in China
Status: Withdrawn Condition: Multiple Sclerosis (Relapsing Remitting)

Study to Assess Safety and Efficacy of Fingolimod in Children With Rett Syndrome
Status: Recruiting Condition: Rett's Syndrome

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

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

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

Fingolimod -Response According to Coping - Evaluation
Status: Completed Condition: Multiple Sclerosis, Relapsing-Remitting

Gilenya in Amyotrophic Lateral Sclerosis (ALS)
Status: Active, not recruiting Condition: Amyotrophic Lateral 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, 2010RXYes5,604,229<disabled>Y<disabled>
Novartis
GILENYA
fingolimod
CAPSULE;ORAL022527-001Sep 21, 2010RXYes<disabled><disabled>
Novartis
GILENYA
fingolimod
CAPSULE;ORAL022527-001Sep 21, 2010RXYes<disabled><disabled>
Novartis
GILENYA
fingolimod
CAPSULE;ORAL022527-001Sep 21, 2010RXYes6,004,565<disabled><disabled>
Novartis
GILENYA
fingolimod
CAPSULE;ORAL022527-001Sep 21, 2010RXYes8,324,283<disabled><disabled>
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International Patent Family for Ingredient: fingolimod

Country Document Number Publication Date
Hong Kong1091114Jun 26, 2009
Israel197578Jul 31, 2011
Norway2011016Sep 19, 2011
CroatiaP20050886Nov 30, 2006
Iceland8114Nov 01, 2005
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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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