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Last Updated: May 26, 2022

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 thirty-four 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. One supplier is 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

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

S1P receptor modulators for treating relasping-remitting multiple sclerosis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Formulations comprising 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 022527-001 Sep 21, 2010 See Plans and Pricing See Plans and Pricing
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-002 May 11, 2018 See Plans and Pricing See Plans and Pricing
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Australia

Patent: 12236357
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2013024430
Estimated Expiration: See Plans and Pricing

Canada

Patent: 31600
Estimated Expiration: See Plans and Pricing

Chile

Patent: 13002810
Estimated Expiration: See Plans and Pricing

China

Patent: 3476400
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 71459
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0170021
Estimated Expiration: See Plans and Pricing

Patent: 0200249
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 18423
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 94037
Estimated Expiration: See Plans and Pricing

Patent: 43990
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 13012912
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 7721
Estimated Expiration: See Plans and Pricing

Patent: 5686
Estimated Expiration: See Plans and Pricing

Patent: 1391442
Estimated Expiration: See Plans and Pricing

Patent: 1790436
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 94037
Estimated Expiration: See Plans and Pricing

Patent: 43990
Estimated Expiration: See Plans and Pricing

Guatemala

Patent: 1300227
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 90309
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 31286
Estimated Expiration: See Plans and Pricing

Israel

Patent: 8250
Estimated Expiration: See Plans and Pricing

Japan

Patent: 19101
Estimated Expiration: See Plans and Pricing

Patent: 14509652
Estimated Expiration: See Plans and Pricing

Jordan

Patent: 77
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 94037
Estimated Expiration: See Plans and Pricing

Patent: 43990
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 3746
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 2522
Estimated Expiration: See Plans and Pricing

Patent: 13011415
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 981
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 5023
Estimated Expiration: See Plans and Pricing

Peru

Patent: 140162
Estimated Expiration: See Plans and Pricing

Patent: 170913
Estimated Expiration: See Plans and Pricing

Poland

Patent: 94037
Estimated Expiration: See Plans and Pricing

Patent: 43990
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 94037
Estimated Expiration: See Plans and Pricing

Patent: 43990
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 917
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 3256
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 94037
Estimated Expiration: See Plans and Pricing

Patent: 43990
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1306636
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 2027014
Estimated Expiration: See Plans and Pricing

Patent: 140014194
Estimated Expiration: See Plans and Pricing

Spain

Patent: 10966
Estimated Expiration: See Plans and Pricing

Patent: 73482
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 28958
Estimated Expiration: See Plans and Pricing

Patent: 1244711
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 13000396
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 2857
Estimated Expiration: See Plans and Pricing

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
Lithuania 3143990 See Plans and Pricing
Australia 2012236357 Formulations comprising 2 -amino- 2- [2- (4 - octylphenyl) ethyl] propane -1, 3 - diol See Plans and Pricing
Morocco 33691 خطة علاج وحدات استقبالات s1p See Plans and Pricing
Eurasian Patent Organization 201391442 ПРЕПАРАТЫ, СОДЕРЖАЩИЕ 2-АМИНО-2-[2-(4-ОКТИЛФЕНИЛ)ЭТИЛ]ПРОПАН-1,3-ДИОЛ See Plans and Pricing
Lithuania 2694037 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for GILENYA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1613288 C01613288/01 Switzerland See Plans and Pricing PRODUCT NAME: FINGOLOMOD; REGISTRATION NO/DATE: SWISSMEDIC 60916 20110103
0627406 CA 2011 00015 Denmark See Plans and Pricing
1613288 2011/027 Ireland See Plans and Pricing 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
1613288 SPC/GB11/045 United Kingdom See Plans and Pricing 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
1613288 107 5008-2011 Slovakia See Plans and Pricing FIRST REGISTRATION NO/DATE: EU/1/11/677/001, EU/1/11/677/002, EU/1/11/677/003, EU/1/11/677/004, 20110317
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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