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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Harvard Business School
Moodys
Dow
QuintilesIMS
Farmers Insurance
McKesson
Medtronic
Argus Health

Generated: May 23, 2018

DrugPatentWatch Database Preview

GILENYA Drug 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 three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and thirty-seven patent family members in forty-two countries.

The generic ingredient in GILENYA is fingolimod. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fingolimod profile page.
Drug patent expirations by year for GILENYA
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
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]-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
BCP9000705
BCPP000225
C-35663
C19H33NO2.HCl
CC-28427
CHEBI:63112
CHEMBL544665
CS-0114
D04187
D0HI1K
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
FT-0643569
Fty 720
Fty-720
FTY-720A
FTY720
FTY720 - Fingolimod
FTY720,Fingolimod
G926EC510T
Gilenia
GP3498
GSK618334
HY-12005
I01-1261
Imusera
IN1328
IN2267
J10426
KB-51874
KS-00000L2J
KS-1172
LS-120139
MFCD00939512
MLS006010179
MolPort-006-666-484
PubChem23815
Q-101363
RL02083
RTX-010897
s5002
SC-21229
SCHEMBL81362
SMR004701287
SR-01000942237
SR-01000942237-2
ST51051590
SWZTYAVBMYWFGS-UHFFFAOYSA-N
TDI-132
UNII-G926EC510T
W-5231

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 CAPSULE;ORAL 022527-001 Sep 21, 2010 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novartis GILENYA fingolimod CAPSULE;ORAL 022527-001 Sep 21, 2010 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novartis GILENYA fingolimod CAPSULE;ORAL 022527-001 Sep 21, 2010 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for GILENYA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Capsules 0.5 mg ➤ Subscribe 2014-09-22

Non-Orange Book US Patents for GILENYA

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
8,741,963 S1P receptor modulators for treating multiple sclerosis ➤ Try a Free Trial
5,719,176 2-amino-1,3-propanediol compound and immunosuppressant ➤ Try a Free Trial
5,952,316 2-amino-1,3-propanediol compound and immunosuppressant ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for GILENYA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2011010 Lithuania ➤ Try a Free 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
C0021 France ➤ Try a Free Trial PRODUCT NAME: FINGOLIMOD ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES EN PARTICULIER SON CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/11/677/001 20110317
9 Finland ➤ Try a Free Trial
90025-5 Sweden ➤ Try a Free Trial PRODUCT NAME: FINGOLIMOD; REG. NO/DATE: EU/1/11/677/001-003 20110317
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Argus Health
Colorcon
Healthtrust
Cerilliant
Moodys
Express Scripts
AstraZeneca
Harvard Business School

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.