You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

AstraZeneca
McKesson
Merck
Colorcon
Harvard Business School
Baxter

Last Updated: February 28, 2020

DrugPatentWatch Database Preview

GILENYA Drug Profile


Email this page to a colleague

See Plans and Pricing

« Back to Dashboard

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 one hundred and eighty-six patent family members in forty-eight countries.

The generic ingredient in GILENYA is fingolimod hydrochloride. There are twenty-one drug master file entries for this compound. Two 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
Wake Forest University Health SciencesEarly Phase 1
National Cancer Institute (NCI)Early Phase 1
Mayo ClinicEarly Phase 1

See all GILENYA clinical trials

Recent Litigation for GILENYA

Identify potential future generic entrants

District Court Litigation
Case NameDate
Novartis Pharmaceuticals Corporation v. Apotex Inc.2020-01-28
Novartis Pharmaceuticals Corporation v. Accord Healthcare Inc.2018-07-16
Novartis Pharmaceuticals Corporation v. Sun Pharmaceutical Industries, Ltd.2018-07-13

See all GILENYA litigation

PTAB Litigation
PetitionerDate
2017-08-16
2017-08-15
2017-06-09

See all GILENYA litigation

Synonyms for GILENYA
1,3-Propanediol, 2-amino-2-(2-(4-octylphenyl)ethyl)-, hydrochloride
1,3-Propanediol, 2-amino-2-[2-(4-octylphenyl)ethyl]-, hydrochloride
1,3-Propanediol, 2-amino-2-[2-(4-octylphenyl)ethyl]-, hydrochloride (1:1)
1346604-90-7
162359-56-0
162359-56-0 , C19H34ClNO2 , Fingolimod (FTY720) , Fty-720 , FTY 720
2-(4-octylphenethyl)-2-aminopropane-1,3-diol hydrochloride
2-Amino-2-(2-(4-octylphenyl)ethyl)-1,3-propanediol hydrochloride
2-amino-2-(2-(4-octylphenyl)ethyl)propane-1,3-diol hydrochloride
2-Amino-2-(2-(4-octylphenyl)ethyl)propane-1,3-diol, HCl
2-Amino-2-(4-octylphenethyl)propane-1,3-diol hydrochloride
2-Amino-2-[2-(4-n-octylphenyl)ethyl]propane-1,3-diol Hydrochloride
2-Amino-2-[2-(4-octyl-phenyl)-ethyl]-propane -1,3-diol hydrochloride
2-AMINO-2-[2-(4-OCTYL-PHENYL)-ETHYL]-PROPANE-1,3-DIOL HCL
2-amino-2-[2-(4-octylphenyl) ethyl]-1,3-propanediol hydrochloride
2-Amino-2-[2-(4-octylphenyl)ethyl]-1,3-propanediol hydrochloride
2-Amino-2-[2-(4-octylphenyl)ethyl]-1,3-propanediol, hydrochloride
2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol hydrochloride
2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol;hydrochloride
359F560
4CA-0534
A25158
A8548
AB0018286
AB1008447
AC-1929
AC1L332T
AK-33554
AKOS005145784
AM84549
AN-444
AOB7477
API0002703
AX8041343
BC679342
BCP01808
BCP9000705
BCPP000225
C-35663
C19H33NO2.HCl
CC-28427
CHEBI:63112
CHEMBL544665
CS-0114
D04187
DTXSID00167364
Epitope ID:156573
EX-A960
F1018
Fin;limod hydrochloride
Fingolimod (FTY-720 HCl)
Fingolimod (FTY720)
Fingolimod (FTY720) HCl
Fingolimod (hydrochloride)
Fingolimod HCl
Fingolimod HClFTY-720
Fingolimod hydrochloride
Fingolimod hydrochloride (JAN/USAN)
Fingolimod hydrochloride [USAN]
Fingolimod hydrochloride FTY720
Fingolimod-d4 Hydrochloride
Fingolimod, HCl
FT-0643569
Fty 720
Fty-720
FTY-720A
FTY720
FTY720 - Fingolimod
FTY720,Fingolimod
G926EC510T
Gilenia
Gilenya (TN)
GP3498
HY-12005
I01-1261
Imusera
IN1328
J10426
KB-51874
KS-00000L2J
KS-1172
LS-120139
MLS006010179
MolPort-006-666-484
PubChem23815
Q-101363
RL02083
RTX-010897
s5002
SC-21229
SCHEMBL81362
SMR004701287
SR-01000942237
SR-01000942237-2
SW219384-1
SWZTYAVBMYWFGS-UHFFFAOYSA-N
TDI-132
UNII-G926EC510T
W-5231
Paragraph IV (Patent) Challenges for GILENYA
Tradename Dosage Ingredient NDA Submissiondate
GILENYA CAPSULE;ORAL fingolimod hydrochloride 022527 2018-07-19
GILENYA CAPSULE;ORAL fingolimod hydrochloride 022527 2018-07-18
GILENYA CAPSULE;ORAL fingolimod hydrochloride 022527 2014-09-22

US Patents and Regulatory Information for GILENYA

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   Start Trial   Start Trial Y   Start Trial
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-002 May 11, 2018 RX Yes No   Start Trial   Start Trial   Start 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   Start Trial   Start Trial
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010   Start Trial   Start Trial
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for GILENYA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1613288 91867 Luxembourg   Start Trial 91867, EXPIRES: 20260317
0627406 1190015-6 Sweden   Start Trial PRODUCT NAME: FINGOLIMOD; REG. NO/DATE: EU/1/11/677/001-04 20110317
1613288 107 5008-2011 Slovakia   Start Trial 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Mallinckrodt
McKinsey
McKesson
Express Scripts
Merck

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.