GILENYA Drug Patent Profile

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.

This drug has two hundred and thirty-four patent family members in fifty 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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Gilenya

A generic version of GILENYA was approved as fingolimod hydrochloride by ACCORD HLTHCARE on October 28^th, 2020.

Summary for GILENYA

International Patents:	234
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	129
Clinical Trials:	32
Patent Applications:	514
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for GILENYA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GILENYA
What excipients (inactive ingredients) are in GILENYA?	GILENYA excipients list
DailyMed Link:	GILENYA at DailyMed

See drug prices for GILENYA

Recent Clinical Trials for GILENYA

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

Sponsor	Phase
The Methodist Hospital Research Institute	Phase 2
Hikma Pharmaceuticals LLC	Phase 1
Genuine Research Center, Egypt	Phase 1

See all GILENYA clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for GILENYA

L04AA	Selective immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for GILENYA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GILENYA	Capsules	fingolimod hydrochloride	0.25 mg	022527	1	2018-07-19
GILENYA	Capsules	fingolimod hydrochloride	0.5 mg	022527	19	2014-09-22

US Patents and Regulatory Information for GILENYA

GILENYA is protected by four US patents.

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

International Patents for GILENYA

When does loss-of-exclusivity occur for GILENYA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Guatemala

Hong Kong

Hungary

Israel

Japan

Jordan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Peru

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering GILENYA around the world.

Country	Patent Number	Title	Estimated Expiration
Lithuania	3143990
Australia	2012236357	Formulations comprising 2 -amino- 2- [2- (4 - octylphenyl) ethyl] propane -1, 3 - diol
Morocco	33691	خطة علاج وحدات استقبالات s1p
Eurasian Patent Organization	201391442	ПРЕПАРАТЫ, СОДЕРЖАЩИЕ 2-АМИНО-2-[2-(4-ОКТИЛФЕНИЛ)ЭТИЛ]ПРОПАН-1,3-ДИОЛ
Lithuania	2694037

Supplementary Protection Certificates for GILENYA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1613288	C01613288/01	Switzerland		PRODUCT NAME: FINGOLOMOD; REGISTRATION NO/DATE: SWISSMEDIC 60916 20110103
0627406	CA 2011 00015	Denmark
1613288	2011/027	Ireland		PRODUCT NAME: GILENYA-FINGOLIMOD; NAT REGISTRATION NO/DATE: EU/1/11/677/001 20110317; FIRST REGISTRATION NO/DATE: EU/1/11/677/002 17/03/2011 IRELAND EU/1/11/677/003 17/03/2011 IRELAND EU/1/11/677/004 20110317
1613288	SPC/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
1613288	107 5008-2011	Slovakia		FIRST REGISTRATION NO/DATE: EU/1/11/677/001, EU/1/11/677/002, EU/1/11/677/003, EU/1/11/677/004, 20110317