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GILENYA Drug Profile

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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 four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-two 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:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list1

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, 2010RXYes9,187,405<disabled> <disabled>
Novartis
GILENYA
fingolimod
CAPSULE;ORAL022527-001Sep 21, 2010RXYes8,324,283<disabled> <disabled>
Novartis
GILENYA
fingolimod
CAPSULE;ORAL022527-001Sep 21, 2010RXYes6,004,565<disabled> <disabled>
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Paragraph IV activity for: GILENYA

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

Non-Orange Book Patents for Tradename: GILENYA

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
5,719,176 2-amino-1,3-propanediol compound and immunosuppressant<disabled in preview>
6,667,025 Compositions and methods of using compositions with accelerated lymphocyte homing immunosuppressive properties<disabled in preview>
5,952,316 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 Tradename: GILENYA

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2004089341<disabled in preview>
Russian Federation2009102278<disabled in preview>
CroatiaP20100601<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: GILENYA

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
90025-5Sweden<disabled>PRODUCT NAME: FINGOLIMOD; REG. NO/DATE: EU/1/11/677/001-003 20110317
0627406/01Switzerland<disabled>FORMER REPRESENTATIVE: BOHEST AG, CH
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