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Last Updated: June 14, 2024

GILENYA Drug Patent Profile


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Which patents cover Gilenya, and what generic alternatives are available?

Gilenya is a drug marketed by Novartis and is included in one NDA. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and forty-six patent family members in fifty countries.

The generic ingredient in GILENYA is fingolimod hydrochloride. There are twenty-one drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the fingolimod hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Gilenya

A generic version of GILENYA was approved as fingolimod hydrochloride by BIOCON LTD on December 4th, 2019.

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Drug patent expirations by year for GILENYA
Drug Prices for GILENYA

See drug prices for GILENYA

Recent Clinical Trials for GILENYA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
The Methodist Hospital Research InstitutePhase 2
Hikma Pharmaceuticals LLCPhase 1
Genuine Research Center, EgyptPhase 1

See all GILENYA clinical trials

Pharmacology for GILENYA
Paragraph IV (Patent) Challenges for GILENYA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
GILENYA Capsules fingolimod hydrochloride 0.25 mg 022527 1 2018-07-19
GILENYA Capsules fingolimod hydrochloride 0.5 mg 022527 19 2014-09-22

US Patents and Regulatory Information for GILENYA

GILENYA is protected by four US patents.

Patents protecting GILENYA

Dosage regimen of an S1P receptor modulator
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF RELAPSING REMITTING MULTIPLE SCLEROSIS BY DETERMINING VARICELLA ZOSTER VIRUS (VZV) STATUS AND VACCINATING PRIOR TO COMMENCING TREATMENT

Solid pharmaceutical compositions comprising a SIP receptor agonist and a sugar alcohol
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

S1P receptor modulators for treating relasping-remitting multiple sclerosis
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Formulations comprising 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 hydrochloride CAPSULE;ORAL 022527-002 May 11, 2018 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for GILENYA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-002 May 11, 2018 ⤷  Sign Up ⤷  Sign Up
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 ⤷  Sign Up ⤷  Sign Up
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for GILENYA

When does loss-of-exclusivity occur for GILENYA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 5749
Estimated Expiration: ⤷  Sign Up

Patent: 4661
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 12236357
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2013024430
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 31600
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 13002810
Estimated Expiration: ⤷  Sign Up

China

Patent: 3476400
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 71459
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0170021
Estimated Expiration: ⤷  Sign Up

Patent: 0200249
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Cyprus

Patent: 18423
Estimated Expiration: ⤷  Sign Up

Patent: 22868
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Denmark

Patent: 94037
Estimated Expiration: ⤷  Sign Up

Patent: 43990
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Ecuador

Patent: 13012912
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 7721
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Patent: 5686
Estimated Expiration: ⤷  Sign Up

Patent: 1391442
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Patent: 1790436
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European Patent Office

Patent: 94037
Estimated Expiration: ⤷  Sign Up

Patent: 43990
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Guatemala

Patent: 1300227
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Hong Kong

Patent: 90309
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Hungary

Patent: 31286
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Israel

Patent: 8250
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 19101
Estimated Expiration: ⤷  Sign Up

Patent: 14509652
Estimated Expiration: ⤷  Sign Up

Jordan

Patent: 77
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 94037
Estimated Expiration: ⤷  Sign Up

Patent: 43990
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 3746
Estimated Expiration: ⤷  Sign Up

Patent: 5633
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Mexico

Patent: 2522
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Patent: 13011415
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Morocco

Patent: 981
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 5023
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Peru

Patent: 140162
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Patent: 170913
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Poland

Patent: 94037
Estimated Expiration: ⤷  Sign Up

Patent: 43990
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Portugal

Patent: 94037
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Patent: 43990
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Serbia

Patent: 917
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Singapore

Patent: 3256
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Slovenia

Patent: 94037
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Patent: 43990
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South Africa

Patent: 1306636
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South Korea

Patent: 2027014
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Patent: 140014194
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Spain

Patent: 10966
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Patent: 73482
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Taiwan

Patent: 28958
Estimated Expiration: ⤷  Sign Up

Patent: 1244711
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Tunisia

Patent: 13000396
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Ukraine

Patent: 2857
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering GILENYA around the world.

Country Patent Number Title Estimated Expiration
Brazil PI0713985 compostos orgÂnicos ⤷  Sign Up
Morocco 34981 FORMULATIONS COMPRENANT 2-AMINO-2-2-4-OCTYLPHENYL)ETHYL)PROPANE-1,3-DIOL ⤷  Sign Up
Chile 2013002810 Composicion farmaceutica solida oral que comprende a) un compuesto 2-amino-2-[2-(4-octil-fenil)-etil]-propano-1,3-diol (fingolimod) en una cantidad de 0,5 mg o menos, o una sal del mismo, b) un relleno y c) un estabilizante que comprende una ciclodextrina; y su uso para tratar una enfermedad autoinmune tal como esclerosis multiple. ⤷  Sign Up
Denmark 1613288 ⤷  Sign Up
Japan 6019101 ⤷  Sign Up
Australia 2018202210 S1P receptor modulators for treating multiple sclerosis ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for GILENYA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1613288 C300497 Netherlands ⤷  Sign Up PRODUCT NAME: FINGOLIMOD ALSMEDE FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN, IN HET BIJZONDER FINGOLIMOD HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/11/677/001-004 20110317
1613288 CA 2011 00023 Denmark ⤷  Sign Up
1613288 PA2011010 Lithuania ⤷  Sign Up 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
0627406 2011020 Ireland ⤷  Sign Up PRODUCT: 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
1613288 1190025-5 Sweden ⤷  Sign Up PERIOD OF VALIDITY (FROM - UNTIL): 20240407 - 20260321
1613288 C20110013 00043 Estonia ⤷  Sign Up PRODUCT NAME: GILENYA - FINGOLIMOD; REG NO/DATE: FINAL 17.03.2011
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.