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Last Updated: March 19, 2024

GILENYA Drug Patent 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 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. Sixteen suppliers are listed for this compound. Additional details are available on the fingolimod hydrochloride profile page.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

S1P receptor modulators for treating relasping-remitting multiple sclerosis
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 ⤷  Try a Trial ⤷  Try a Trial
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 ⤷  Try a Trial ⤷  Try a Trial
>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: ⤷  Try a Trial

Patent: 4661
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 12236357
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2013024430
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 31600
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 13002810
Estimated Expiration: ⤷  Try a Trial

China

Patent: 3476400
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 71459
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0170021
Estimated Expiration: ⤷  Try a Trial

Patent: 0200249
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 18423
Estimated Expiration: ⤷  Try a Trial

Patent: 22868
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 94037
Estimated Expiration: ⤷  Try a Trial

Patent: 43990
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 13012912
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 7721
Estimated Expiration: ⤷  Try a Trial

Patent: 5686
Estimated Expiration: ⤷  Try a Trial

Patent: 1391442
Estimated Expiration: ⤷  Try a Trial

Patent: 1790436
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 94037
Estimated Expiration: ⤷  Try a Trial

Patent: 43990
Estimated Expiration: ⤷  Try a Trial

Guatemala

Patent: 1300227
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 90309
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 31286
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 8250
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 19101
Estimated Expiration: ⤷  Try a Trial

Patent: 14509652
Estimated Expiration: ⤷  Try a Trial

Jordan

Patent: 77
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 94037
Estimated Expiration: ⤷  Try a Trial

Patent: 43990
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 3746
Estimated Expiration: ⤷  Try a Trial

Patent: 5633
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 2522
Estimated Expiration: ⤷  Try a Trial

Patent: 13011415
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 981
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 5023
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 140162
Estimated Expiration: ⤷  Try a Trial

Patent: 170913
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 94037
Estimated Expiration: ⤷  Try a Trial

Patent: 43990
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 94037
Estimated Expiration: ⤷  Try a Trial

Patent: 43990
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 917
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 3256
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 94037
Estimated Expiration: ⤷  Try a Trial

Patent: 43990
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1306636
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 2027014
Estimated Expiration: ⤷  Try a Trial

Patent: 140014194
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 10966
Estimated Expiration: ⤷  Try a Trial

Patent: 73482
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 28958
Estimated Expiration: ⤷  Try a Trial

Patent: 1244711
Estimated Expiration: ⤷  Try a Trial

Tunisia

Patent: 13000396
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 2857
Estimated Expiration: ⤷  Try a Trial

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
South Korea 0155015 ⤷  Try a Trial
Denmark 1613288 ⤷  Try a Trial
European Patent Office 2698154 Modulateurs du récepteur S1P pour traiter la sclérose en plaques (S1P receptor modulators for treating multiple sclerosis) ⤷  Try a Trial
Greece 1005052 ΣΥΝΘΕΣΕΙΣ ΠΕΡΙΕΧΟΥΣΕΣ ΑΓΩΝΙΣΤΗ ΥΠΟΔΟΧΕΩΝ S1P (COMPOSITIONS COMPRISING S1P RESPECTOR AGONIST) ⤷  Try a Trial
Japan 2016185957 多発性硬化症を処置するためのS1P受容体モジュレーター (S1P RECEPTOR MODULATORS FOR TREATING MULTIPLE SCLEROSIS) ⤷  Try a Trial
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. ⤷  Try a Trial
Eurasian Patent Organization 201790436 ПРЕПАРАТЫ, СОДЕРЖАЩИЕ 2-АМИНО-2-[2-(4-ОКТИЛФЕНИЛ)ЭТИЛ]ПРОПАН-1,3-ДИОЛ ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for GILENYA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1613288 C20110013 00043 Estonia ⤷  Try a Trial PRODUCT NAME: GILENYA - FINGOLIMOD; REG NO/DATE: FINAL 17.03.2011
1613288 C300497 Netherlands ⤷  Try a Trial PRODUCT NAME: FINGOLIMOD ALSMEDE FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN, IN HET BIJZONDER FINGOLIMOD HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/11/677/001-004 20110317
1613288 2011/027 Ireland ⤷  Try a Trial PRODUCT 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
0627406 C00627406/01 Switzerland ⤷  Try a Trial FORMER REPRESENTATIVE: BOHEST AG, CH
1613288 PA2011010 Lithuania ⤷  Try a Trial 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
1613288 122011100047 Germany ⤷  Try a Trial PRODUCT NAME: FINGOLIMOD ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON; NAT. REGISTRATION NO/DATE: FIRST REGISTRATION: EU EU/1/11/677/001-004 20110317EU/1/11/677/001 EU/1/11/677/002 EU/1/11/677/003 EU/1/11/677/004 20110317
0627406 SPC/GB11/026 United Kingdom ⤷  Try a Trial PRODUCT 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
>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.