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Fingolimod - Generic Drug Details

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

This ingredient has one hundred and twenty-three 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:4
Applicants:1
NDAs:1
Drug Master File Entries: see list18
Suppliers / Packaging: see list1
Drug Prices:see low prices

Pharmacology for Ingredient: fingolimod

Clinical Trials for: fingolimod

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, 2010RXYes6,004,565Sep 23, 2017
Novartis
GILENYA
fingolimod
CAPSULE;ORAL022527-001Sep 21, 2010RXYes9,187,405Jun 25, 2027
Novartis
GILENYA
fingolimod
CAPSULE;ORAL022527-001Sep 21, 2010RXYesSep 21, 2015
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Non-Orange Book Patents for Generic Ingredient: fingolimod

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,667,025 Compositions and methods of using compositions with accelerated lymphocyte homing immunosuppressive properties<disabled in preview>
8,741,963S1P receptor modulators for treating multiple sclerosis<disabled in preview>
5,719,176 2-amino-1,3-propanediol compound and immunosuppressant<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: fingolimod

Country Document Number Estimated Expiration
European Patent Office2008650<disabled in preview>
Cyprus1110260<disabled in preview>
Argentina078781<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: FINGOLIMOD

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB11/026United Kingdom<disabled>PRODUCT NAME: FINGOLIMOD, I.E. 2-AMINO-2-(2-(4-OCTYLPHENYL)ETHYL)PROPANE-1,3-DIOL, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/11/677/001 20110317; UK EU/1/11/677/002 20110317; UK EU/1/11/677/003 20110317; UK EU/1/11/677/004 20110317
11020Ireland<disabled>PRODUCT: GILENYA FINGOLIMOD AND/OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF REGISTRATION NO/DATE: IRELAND EU/1/11/677/001, EU/1/11/677/002, EU/1/11/677/003, EU/1/11/677/004 / 17/03/2011; FIRST REGISTRATION NO/DATE: EUROPEAN UNION EU/1/11/677/001, EU/1/11/677/002, EU/1/11/677/003, EU/1/11/677/004 / 17/03/2011
2011010Lithuania<disabled>PRODUCT NAME: FINGOLIMODUM; REGISTRATION NO/DATE: EU/1/11/677/001, 2011 03 17 EU/1/11/677/002, 2011 03 17 EU/1/11/677/003, 2011 03 17 EU/1/11/677/004 20110317
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