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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 three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and thirty-seven patent family members in forty-two countries.

The generic ingredient in GILENYA is fingolimod. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fingolimod profile page.

Summary for GILENYA

International Patents:	137
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	91
Clinical Trials:	23
Patent Applications:	1,446
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GILENYA
DailyMed Link:	GILENYA at DailyMed

Pharmacology for GILENYA

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

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	CAPSULE;ORAL	022527-001	Sep 21, 2010		RX	Yes	Yes					Y
Novartis	GILENYA	fingolimod	CAPSULE;ORAL	022527-001	Sep 21, 2010		RX	Yes	Yes					Y
Novartis	GILENYA	fingolimod	CAPSULE;ORAL	022527-001	Sep 21, 2010		RX	Yes	Yes					Y

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Expired US Patents for GILENYA

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

Paragraph IV (Patent) Challenges for GILENYA

Drugname	Dosage	Strength	RLD	Submissiondate
	Capsules	0.5 mg		2014-09-22

Non-Orange Book US Patents for GILENYA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,741,963	S1P receptor modulators for treating multiple sclerosis
5,719,176	2-amino-1,3-propanediol compound and immunosuppressant
5,952,316	2-amino-1,3-propanediol compound and immunosuppressant

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International Patents for GILENYA

Country	Document Number	Estimated Expiration
Peru	13522013
Tunisia	SN05256
Taiwan	I332847
European Patent Office	2037906

Supplementary Protection Certificates for GILENYA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2011010	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
C0021	France		PRODUCT NAME: FINGOLIMOD ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES EN PARTICULIER SON CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/11/677/001 20110317
9	Finland
90025-5	Sweden		PRODUCT NAME: FINGOLIMOD; REG. NO/DATE: EU/1/11/677/001-003 20110317