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Serving leading biopharmaceutical companies globally:

Colorcon
Chinese Patent Office
US Army
Novartis
AstraZeneca
Teva
Julphar
Cantor Fitzgerald
Harvard Business School
Citi

Generated: December 12, 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-seven patent family members in forty-two 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.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
NovartisGILENYAfingolimodCAPSULE;ORAL022527-001Sep 21, 2010RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
NovartisGILENYAfingolimodCAPSULE;ORAL022527-001Sep 21, 2010RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
NovartisGILENYAfingolimodCAPSULE;ORAL022527-001Sep 21, 2010RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
NovartisGILENYAfingolimodCAPSULE;ORAL022527-001Sep 21, 2010RXYesYes► Subscribe► Subscribe► 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
8,741,963S1P 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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International Patent Family for Tradename: GILENYA

Country Document Number Estimated Expiration
South Korea20090024281► Subscribe
Japan2004307506► Subscribe
Germany102004016947► Subscribe
China103550195► Subscribe
South Korea20150122812► Subscribe
European Patent Office0627406► Subscribe
BrazilPI0409250► Subscribe
Russian Federation2475237► Subscribe
Hong Kong1214758► Subscribe
Peru07432009► 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
90015-6Sweden► SubscribePRODUCT NAME: FINGOLIMOD; REG. NO/DATE: EU/1/11/677/001-04 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
00497Netherlands► SubscribePRODUCT NAME: FINGOLIMOD ALSMEDE FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN, IN HET BIJZONDER FINGOLIMOD HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/11/677/001-004 20110317
C0021France► SubscribePRODUCT NAME: FINGOLIMOD ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES EN PARTICULIER SON CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/11/677/001 20110317
867Luxembourg► Subscribe91867, EXPIRES: 20260317
2011 00023Denmark► Subscribe
7 5008-2011Slovakia► SubscribeFIRST REGISTRATION NO/DATE: EU/1/11/677/001, EU/1/11/677/002, EU/1/11/677/003, EU/1/11/677/004, 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
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
90025-5Sweden► SubscribePRODUCT NAME: FINGOLIMOD; REG. NO/DATE: EU/1/11/677/001-003 20110317
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For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Mallinckrodt
Cantor Fitzgerald
US Department of Justice
Medtronic
Harvard Business School
Fuji
US Army
Express Scripts
QuintilesIMS

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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