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Serving leading biopharmaceutical companies globally:

Baxter
AstraZeneca
QuintilesIMS
Deloitte
US Department of Justice
US Army
McKesson
Novartis
Colorcon
Cipla

Generated: October 21, 2017

DrugPatentWatch Database Preview

GILENYA Drug Profile

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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.

This drug has one hundred and thirty-six patent family members in forty-one countries and twenty-one supplementary protection certificates in twelve 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

US Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list74
Clinical Trials: see list22
Patent Applications: see list1,238
Drug Prices:see details
DailyMed Link:GILENYA at DailyMed

Pharmacology for Tradename: GILENYA

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;ORAL022527-001Sep 21, 2010RXYesYes► Subscribe► Subscribe ► Subscribe
Novartis
GILENYA
fingolimod
CAPSULE;ORAL022527-001Sep 21, 2010RXYesYes► Subscribe► Subscribe ► Subscribe
Novartis
GILENYA
fingolimod
CAPSULE;ORAL022527-001Sep 21, 2010RXYesYes► Subscribe► Subscribe ► Subscribe
Novartis
GILENYA
fingolimod
CAPSULE;ORAL022527-001Sep 21, 2010RXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Tradename: GILENYA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
GILENYA
fingolimod
CAPSULE;ORAL022527-001Sep 21, 2010► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges 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► Subscribe
6,667,025 Compositions and methods of using compositions with accelerated lymphocyte homing immunosuppressive properties► Subscribe
8,741,963S1P 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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International Patent Family for Tradename: GILENYA

Country Document Number Estimated Expiration
Australia2013200356► Subscribe
TaiwanI332847► Subscribe
Iceland8114► Subscribe
ItalyMI20040682► Subscribe
Singapore175449► Subscribe
South Korea20110005320► Subscribe
Japan5543298► Subscribe
European Patent Office2698154► Subscribe
South Korea20140069178► Subscribe
Slovenia1613288► 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.

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Supplementary Protection Certificates for Tradename: GILENYA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0021France► SubscribePRODUCT NAME: FINGOLIMOD ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES EN PARTICULIER SON CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/11/677/001 20110317
C/GB11/026United Kingdom► SubscribePRODUCT 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
C/GB11/045United Kingdom► SubscribePRODUCT 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
90015-6Sweden► SubscribePRODUCT NAME: FINGOLIMOD; REG. NO/DATE: EU/1/11/677/001-04 20110317
9Finland► Subscribe
2011010,C1613288Lithuania► SubscribePRODUCT 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
11020Ireland► SubscribePRODUCT: 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
2011 00023Denmark► SubscribePRODUCT NAME: FINGOLIMOD, HERUNDER FINGOLIMOD SOM HYDROCHLORID; REG. NO/DATE: EU/1/11/677/001-004 20110317
00488Netherlands► SubscribePRODUCT NAME: FINGOLIMOD, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER FINGOLIMOD HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/11/677/001-004 20110317
00497Netherlands► SubscribePRODUCT NAME: FINGOLIMOD ALSMEDE FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN, IN HET BIJZONDER FINGOLIMOD HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/11/677/001-004 20110317
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Accenture
Fish and Richardson
Colorcon
AstraZeneca
Julphar
Cantor Fitzgerald
McKinsey
Chinese Patent Office
Novartis
Fuji

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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