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Generated: June 26, 2019

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FINGOLIMOD HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for fingolimod hydrochloride and what is the scope of fingolimod hydrochloride patent protection?

Fingolimod hydrochloride is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fingolimod hydrochloride has one hundred and eighty-three patent family members in forty-eight countries.

There are twenty-one drug master file entries for fingolimod hydrochloride. One supplier is listed for this compound.

Summary for FINGOLIMOD HYDROCHLORIDE
Pharmacology for FINGOLIMOD HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for FINGOLIMOD HYDROCHLORIDE
Synonyms for FINGOLIMOD HYDROCHLORIDE
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-octyl-phenyl)-ethyl]-propane-1,3-diol 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]-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
EC-000.2314
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 (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
Gilenya (TN)
GP3498
HY-12005
I01-1261
Imusera
IN1328
J10426
KS-00000L2J
KS-1172
LS-120139
MFCD00939512
MLS006010179
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

US Patents and Regulatory Information for FINGOLIMOD HYDROCHLORIDE

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 Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-002 May 11, 2018 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novartis GILENYA fingolimod hydrochloride 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 hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis GILENYA fingolimod hydrochloride 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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Supplementary Protection Certificates for FINGOLIMOD HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1613288 2011C/030 Belgium ➤ Try a Free Trial PRODUCT NAME: FINGOLIMOD; AUTHORISATION NUMBER AND DATE: EU/1/11/677/001 20110322
1613288 PA2011010 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
0627406 11C0021 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
0627406 C300488 Netherlands ➤ Try a Free Trial PRODUCT NAME: FINGOLIMOD, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER FINGOLIMOD HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/11/677/001-004 20110317
1613288 C20110013 00043 Estonia ➤ Try a Free Trial PRODUCT NAME: GILENYA - FINGOLIMOD; REG NO/DATE: FINAL 17.03.2011
1613288 C01613288/01 Switzerland ➤ Try a Free Trial FORMER REPRESENTATIVE: BOHEST AG, CH
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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