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GILENYA Drug Profile

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Which patents cover Gilenya, and what generic alternatives are available?

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.

The generic ingredient in GILENYA is fingolimod hydrochloride. There are twenty 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

US Patents:	4
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	99
Clinical Trials:	23
Patent Applications:	92
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for GILENYA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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

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 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	Document Number	Estimated Expiration
Australia	2013200356
Taiwan	I332847
Iceland	8885
Japan	2004307506
Slovenia	1613288
South Korea	20120101148
South Korea	101367574

Supplementary Protection Certificates for GILENYA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0021	France		PRODUCT NAME: FINGOLIMOD ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES EN PARTICULIER SON CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/11/677/001 20110317
C/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
C/GB11/045	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
90015-6	Sweden		PRODUCT NAME: FINGOLIMOD; REG. NO/DATE: EU/1/11/677/001-04 20110317
9	Finland
2011010,C1613288	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
11020	Ireland		PRODUCT: GILENYA FINGOLIMOD AND/OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF REGISTRATION NO/DATE: IRELAND EU/1/11/677/001, EU/1/11/677/002, EU/1/11/677/003, EU/1/11/677/004 / 17/03/2011; FIRST REGISTRATION NO/DATE: EUROPEAN UNION EU/1/11/677/001, EU/1/11/677/002, EU/1/11/677/003, EU/1/11/677/004 / 17/03/2011