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Generated: September 24, 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 | ► Subscribe | ► Subscribe | ► Subscribe | ||||
Novartis | GILENYA | fingolimod | CAPSULE;ORAL | 022527-001 | Sep 21, 2010 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||
Novartis | GILENYA | fingolimod | CAPSULE;ORAL | 022527-001 | Sep 21, 2010 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||
Novartis | GILENYA | fingolimod | CAPSULE;ORAL | 022527-001 | Sep 21, 2010 | RX | Yes | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | GILENYA | fingolimod | CAPSULE;ORAL | 022527-001 | Sep 21, 2010 | ► 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 | |||||||||||||
| 8,741,963 | S1P receptor modulators for treating multiple sclerosis | ► Subscribe | |||||||||||||
| 6,667,025 | Compositions and methods of using compositions with accelerated lymphocyte homing immunosuppressive properties | ► 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 | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Croatia | P20100601 | ► Subscribe | |||||||||||||
| China | 1767819 | ► Subscribe | |||||||||||||
| South Korea | 20120101148 | ► Subscribe | |||||||||||||
| European Patent Office | 2769713 | ► Subscribe | |||||||||||||
| Russian Federation | 2617502 | ► Subscribe | |||||||||||||
| Mexico | PA05010860 | ► Subscribe | |||||||||||||
| Germany | 602004017847 | ► Subscribe | |||||||||||||
| Spain | 2556947 | ► Subscribe | |||||||||||||
| New Zealand | 542622 | ► Subscribe | |||||||||||||
| Taiwan | 200503784 | ► 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 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 0110013 00043 | Estonia | ► Subscribe | PRODUCT NAME: GILENYA - FINGOLIMOD; REG NO/DATE: FINAL 17.03.2011 | ||||||||||||
| 0627406/01 | Switzerland | ► Subscribe | FORMER REPRESENTATIVE: BOHEST AG, CH | ||||||||||||
| 1613288/01 | Switzerland | ► Subscribe | FORMER REPRESENTATIVE: BOHEST AG, CH | ||||||||||||
| 90025-5 | Sweden | ► Subscribe | PRODUCT NAME: FINGOLIMOD; REG. NO/DATE: EU/1/11/677/001-003 20110317 | ||||||||||||
| C/GB11/026 | United Kingdom | ► Subscribe | 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 00015 | Denmark | ► Subscribe | |||||||||||||
| 2011 00023 | Denmark | ► Subscribe | |||||||||||||
| C0021 | France | ► Subscribe | PRODUCT NAME: FINGOLIMOD ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES EN PARTICULIER SON CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/11/677/001 20110317 | ||||||||||||
| 867 | Luxembourg | ► Subscribe | 91867, EXPIRES: 20260317 | ||||||||||||
| 2011010 | 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 | ||||||||||||
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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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