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Generated: July 20, 2017
Which patents cover Gilenya, and when can generic versions of Gilenya launch?
Gilenya is a drug marketed by Novartis and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.| Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: see list | 1 |
| Bulk Api Vendors: see list | 74 |
| Clinical Trials: see list | 22 |
| Patent Applications: see list | 1,238 |
| Drug Prices: | see details |
| DailyMed Link: | GILENYA at DailyMed |
| Drug Class | Sphingosine 1-phosphate Receptor Modulator |
| Mechanism of Action | Sphingosine 1-Phosphate Receptor Modulators |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | GILENYA | fingolimod | CAPSULE;ORAL | 022527-001 | Sep 21, 2010 | RX | Yes | Yes | 8,324,283 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Novartis | GILENYA | fingolimod | CAPSULE;ORAL | 022527-001 | Sep 21, 2010 | RX | Yes | Yes | 9,187,405 | ► Subscribe | ► Subscribe | ||||||||||||||||||
Novartis | GILENYA | fingolimod | CAPSULE;ORAL | 022527-001 | Sep 21, 2010 | RX | Yes | Yes | 5,604,229 | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Novartis | GILENYA | fingolimod | CAPSULE;ORAL | 022527-001 | Sep 21, 2010 | RX | Yes | Yes | 6,004,565 | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| fingolimod | Capsules | 0.5 mg | Gilenya | 9/22/2014 |
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 | ► Subscribe | |||||||||||||||||||||||||||
| 6,667,025 | Compositions and methods of using compositions with accelerated lymphocyte homing immunosuppressive properties | ► Subscribe | |||||||||||||||||||||||||||
| 8,741,963 | S1P receptor modulators for treating multiple sclerosis | ► Subscribe | |||||||||||||||||||||||||||
| 5,952,316 | 2-amino-1,3-propanediol compound and immunosuppressant | ► Subscribe | |||||||||||||||||||||||||||
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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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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cyprus | 2215 | ► Subscribe | |||||||||||||||||||||||||||
| Portugal | 1613288 | ► Subscribe | |||||||||||||||||||||||||||
| Slovenia | 1613288 | ► Subscribe | |||||||||||||||||||||||||||
| Russian Federation | 2013131176 | ► Subscribe | |||||||||||||||||||||||||||
| Spain | 2556947 | ► Subscribe | |||||||||||||||||||||||||||
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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.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2011 00015 | Denmark | ► Subscribe | |||||||||||||||||||||||||||
| 11/027 | Ireland | ► Subscribe | PRODUCT NAME: GILENYA-FINGOLIMOD; NAT REGISTRATION NO/DATE: EU/1/11/677/001 20110317; FIRST REGISTRATION NO/DATE: EU/1/11/677/002 17/03/2011 IRELAND EU/1/11/677/003 17/03/2011 IRELAND EU/1/11/677/004 20110317 | ||||||||||||||||||||||||||
| 2011010,C1613288 | Lithuania | ► Subscribe | 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 | ||||||||||||||||||||||||||
| 90015-6 | Sweden | ► Subscribe | PRODUCT NAME: FINGOLIMOD; REG. NO/DATE: EU/1/11/677/001-04 20110317 | ||||||||||||||||||||||||||
| 11020 | Ireland | ► Subscribe | 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 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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