.

Deeper Knowledge, Faster

  • Analyze global market entry opportunities
  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Citi
QuintilesIMS
Harvard Business School
Colorcon
McKesson
Farmers Insurance
Fish and Richardson
US Army
Daiichi Sankyo
Johnson and Johnson

Generated: December 15, 2017

DrugPatentWatch Database Preview

Fingolimod - Generic Drug Details

« Back to Dashboard

What are the generic sources for fingolimod and what is the scope of fingolimod freedom to operate?

Fingolimod
is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fingolimod has one hundred and thirty-seven patent family members in forty-two countries and twenty-one supplementary protection certificates in twelve countries.

There are eighteen drug master file entries for fingolimod. One supplier is listed for this compound. There are two tentative approvals for this compound.

Pharmacology for fingolimod

Tentative approvals for FINGOLIMOD

Applicant Application No. Strength Dosage Form
u► Subscribe0.5MGCAPSULE;ORAL
u► Subscribe0.5MGCAPSULE;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
NovartisGILENYAfingolimodCAPSULE;ORAL022527-001Sep 21, 2010RXYesYes► Subscribe► Subscribe► Subscribe
NovartisGILENYAfingolimodCAPSULE;ORAL022527-001Sep 21, 2010RXYesYes► Subscribe► Subscribe► Subscribe
NovartisGILENYAfingolimodCAPSULE;ORAL022527-001Sep 21, 2010RXYesYes► Subscribe► SubscribeY► Subscribe
NovartisGILENYAfingolimodCAPSULE;ORAL022527-001Sep 21, 2010RXYesYes► Subscribe► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Orange Book Patents for Generic Ingredient: fingolimod

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
NovartisGILENYAfingolimodCAPSULE;ORAL022527-001Sep 21, 2010► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Non-Orange Book Patents for Generic Ingredient: fingolimod

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
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: fingolimod

Country Document Number Estimated Expiration
HungaryE028247► Subscribe
Israel170888► Subscribe
Australia2011201844► Subscribe
Russian Federation2010147000► Subscribe
Argentina078782► Subscribe
Hong Kong1013281► Subscribe
Israel242037► Subscribe
South Korea0155015► Subscribe
Hong Kong1071685► Subscribe
Peru06762015► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: FINGOLIMOD

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
867Luxembourg► Subscribe91867, EXPIRES: 20260317
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
2011010Lithuania► 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
0627406/01Switzerland► SubscribeFORMER REPRESENTATIVE: BOHEST AG, CH
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
1613288/01Switzerland► SubscribeFORMER REPRESENTATIVE: BOHEST AG, CH
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
0110013 00043Estonia► SubscribePRODUCT NAME: GILENYA - FINGOLIMOD; REG NO/DATE: FINAL 17.03.2011
9Finland► Subscribe
90025-5Sweden► SubscribePRODUCT NAME: FINGOLIMOD; REG. NO/DATE: EU/1/11/677/001-003 20110317
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Fish and Richardson
Cerilliant
Citi
Medtronic
Deloitte
Healthtrust
US Department of Justice
Daiichi Sankyo
Merck
Teva

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot