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

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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Last Updated: November 22, 2019

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 four patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and eighty-four 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. 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

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Generic Entry Opportunity Date for GILENYA
Generic Entry Date for GILENYA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for GILENYA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Wake Forest University Health SciencesEarly Phase 1
Mayo ClinicEarly Phase 1
National Cancer Institute (NCI)Early 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. Accord Healthcare Inc.2018-07-16
Novartis Pharmaceuticals Corporation v. Apotex Inc.2018-07-13
Novartis Pharmaceuticals Corporation v. Teva Pharmaceuticals USA, Inc.2018-07-13

See all GILENYA litigation

PTAB Litigation
PetitionerDate
Sun Pharmaceutical Industries, Ltd.2017-08-16
Actavis Elizabeth LLC2017-08-15
Argentum Pharmaceuticals LLC2017-06-09

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 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
Novartis GILENYA fingolimod hydrochloride CAPSULE;ORAL 022527-001 Sep 21, 2010 RX Yes Yes   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 C20110013 00043 Estonia   Start Trial PRODUCT NAME: GILENYA - FINGOLIMOD; REG NO/DATE: FINAL 17.03.2011
1613288 C300497 Netherlands   Start Trial PRODUCT NAME: FINGOLIMOD ALSMEDE FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN, IN HET BIJZONDER FINGOLIMOD HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/11/677/001-004 20110317
0627406 1190015-6 Sweden   Start Trial PRODUCT NAME: FINGOLIMOD; REG. NO/DATE: EU/1/11/677/001-04 20110317
0627406 C00627406/01 Switzerland   Start Trial FORMER REPRESENTATIVE: BOHEST AG, CH
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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McKinsey
Dow
Boehringer Ingelheim

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