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Serving 500+ biopharmaceutical companies globally:

Fuji
Cipla
Merck
Farmers Insurance
Daiichi Sankyo
Harvard Business School
US Army
McKinsey
Johnson and Johnson
Novartis

Generated: July 20, 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 twenty-eight patent family members in forty-one 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
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, 2010RXYesYes8,324,283► Subscribe ► Subscribe
Novartis
GILENYA
fingolimod
CAPSULE;ORAL022527-001Sep 21, 2010RXYesYes9,187,405► Subscribe ► Subscribe
Novartis
GILENYA
fingolimod
CAPSULE;ORAL022527-001Sep 21, 2010RXYesYes5,604,229► SubscribeY ► Subscribe
Novartis
GILENYA
fingolimod
CAPSULE;ORAL022527-001Sep 21, 2010RXYesYes6,004,565► Subscribe ► Subscribe
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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► 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
Cyprus2215► Subscribe
Portugal1613288► Subscribe
Slovenia1613288► Subscribe
Russian Federation2013131176► Subscribe
Spain2556947► 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
2011 00015Denmark► Subscribe
11/027Ireland► SubscribePRODUCT 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,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
90015-6Sweden► SubscribePRODUCT NAME: FINGOLIMOD; REG. NO/DATE: EU/1/11/677/001-04 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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

US Army
QuintilesIMS
McKinsey
Chubb
Chinese Patent Office
Daiichi Sankyo
Julphar
Express Scripts
Teva
Medtronic

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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