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GILENYA Drug Profile
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This drug has one hundred and twenty-three 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 list | 1 |
| Drug Prices: : | see details |
Pharmacology for Tradename: GILENYA
| Drug Class | Sphingosine 1-phosphate Receptor Modulator |
| Mechanism of Action | Sphingosine 1-Phosphate Receptor Modulators |
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;ORAL | 022527-001 | Sep 21, 2010 | RX | Yes | 9,187,405 | Jun 25, 2027 | ||||||||||||||||||||
Novartis | GILENYA | fingolimod | CAPSULE;ORAL | 022527-001 | Sep 21, 2010 | RX | Yes | 8,324,283 | Mar 29, 2026 | ||||||||||||||||||||
Novartis | GILENYA | fingolimod | CAPSULE;ORAL | 022527-001 | Sep 21, 2010 | RX | Yes | 6,004,565 | Sep 23, 2017 | ||||||||||||||||||||
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Paragraph IV activity for: GILENYA
| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| fingolimod | Capsules | 0.5 mg | Gilenya | 9/22/2014 |
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> | |||||||||||||||||||||||||||
| 8,741,963 | S1P receptor modulators for treating multiple sclerosis | <disabled in preview> | |||||||||||||||||||||||||||
| 6,667,025 | Compositions and methods of using compositions with accelerated lymphocyte homing immunosuppressive properties | <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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| European Patent Office | 0627406 | <disabled in preview> | |||||||||||||||||||||||||||
| Australia | 2007264031 | <disabled in preview> | |||||||||||||||||||||||||||
| Norway | 20055231 | <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.
Export unavailable in trial.
Subscribe for complete access.
Supplementary Protection Certificates for Tradename: GILENYA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 90015-6 | Sweden | <disabled> | PRODUCT NAME: FINGOLIMOD; REG. NO/DATE: EU/1/11/677/001-04 20110317 | ||||||||||||||||||||||||||
| C/GB11/045 | United 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 | ||||||||||||||||||||||||||
| 2011 00023 | Denmark | <disabled> | |||||||||||||||||||||||||||
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