Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 14, 2019

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Fingolimod hydrochloride - Generic Drug Details

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What are the generic drug sources for fingolimod hydrochloride and what is the scope of freedom to operate?

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-four 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
Recent Clinical Trials for fingolimod hydrochloride

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 fingolimod hydrochloride clinical trials

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
Paragraph IV (Patent) Challenges for FINGOLIMOD HYDROCHLORIDE
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 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   Start Trial   Start Trial   Start Trial
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-002 May 11, 2018 RX Yes No   Start Trial   Start Trial   Start Trial
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 RX Yes Yes   Start Trial   Start Trial Y   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 fingolimod hydrochloride

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 fingolimod hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1613288 CA 2011 00023 Denmark   Start Trial
1613288 SPC/GB11/045 United Kingdom   Start 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
1613288 C01613288/01 Switzerland   Start Trial FORMER REPRESENTATIVE: BOHEST AG, CH
1613288 91867 Luxembourg   Start Trial 91867, EXPIRES: 20260317
1613288 CR 2011 00023 Denmark   Start Trial PRODUCT NAME: FINGOLIMOD, HERUNDER FINGOLIMOD SOM HYDROCHLORID; REG. NO/DATE: EU/1/11/677/001-004 20110317
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
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Harvard Business School
Baxter
McKinsey
Boehringer Ingelheim

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