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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-two 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.

Summary for GILENYA

International Patents:	182
US Patents:	4
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	102
Clinical Trials:	24
Patent Applications:	100
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for GILENYA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GILENYA
Prior Art and Litigation Support	Order Prior Art and Litigation support for GILENYA
DailyMed Link:	GILENYA at DailyMed

Generic Entry Opportunity Date for GILENYA

NDA:

022527

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.

Pharmacology for GILENYA

Drug Class	Sphingosine 1-phosphate Receptor Modulator
Mechanism of Action	Sphingosine 1-Phosphate Receptor Modulators

Medical Subject Heading (MeSH) Categories for GILENYA

Immunosuppressive Agents

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

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					Y
Novartis	GILENYA	fingolimod hydrochloride	CAPSULE;ORAL	022527-001	Sep 21, 2010		RX	Yes	Yes					Y
Novartis	GILENYA	fingolimod hydrochloride	CAPSULE;ORAL	022527-002	May 11, 2018		RX	Yes	No
Novartis	GILENYA	fingolimod hydrochloride	CAPSULE;ORAL	022527-001	Sep 21, 2010		RX	Yes	Yes
Novartis	GILENYA	fingolimod hydrochloride	CAPSULE;ORAL	022527-002	May 11, 2018		RX	Yes	No					Y
Novartis	GILENYA	fingolimod hydrochloride	CAPSULE;ORAL	022527-002	May 11, 2018		RX	Yes	No
Novartis	GILENYA	fingolimod hydrochloride	CAPSULE;ORAL	022527-001	Sep 21, 2010		RX	Yes	Yes					Y

Expired US Patents for GILENYA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	GILENYA	fingolimod hydrochloride	CAPSULE;ORAL	022527-001	Sep 21, 2010

Paragraph IV (Patent) Challenges for GILENYA

Drugname	Dosage	Strength	RLD	Date
	Capsules	0.25 mg
	Capsules	0.5 mg

International Patents for GILENYA

Country	Patent Number	Estimated Expiration
Peru	07432009
Slovenia	2316431
Taiwan	200503784
Slovenia	2694037
European Patent Office	1613288
Peru	03962005
Brazil	PI0713985

Supplementary Protection Certificates for GILENYA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1613288	PA2011010	Lithuania		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		PRODUCT NAME: FINGOLIMOD ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES EN PARTICULIER SON CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/11/677/001 20110317
1613288	399	Finland
1613288	1190025-5	Sweden		PERIOD OF VALIDITY (FROM - UNTIL): 20240407 - 20260321
0627406	C00627406/01	Switzerland		FORMER REPRESENTATIVE: BOHEST AG, CH
0627406	SPC/GB11/026	United Kingdom		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	C300497	Netherlands		PRODUCT NAME: FINGOLIMOD ALSMEDE FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN, IN HET BIJZONDER FINGOLIMOD HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/11/677/001-004 20110317