Fingolimod hydrochloride - Generic Drug Details

What are the generic sources for fingolimod hydrochloride and what is the scope of patent protection?

Fingolimod hydrochloride is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Alkem Labs Ltd, Apotex, Aurobindo Pharma Ltd, Biocon Ltd, Bionpharma, Chartwell Rx, Dr Reddys, Ezra Ventures, Glenmark Pharms Ltd, Hec Pharm Co Ltd, Hetero Labs Ltd V, Mylan, Prinston Inc, Sun Pharm, Teva Pharms Usa, Zydus Pharms, and Novartis, and is included in nineteen NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fingolimod hydrochloride has two hundred and forty-six patent family members in fifty countries.

There are twenty drug master file entries for fingolimod hydrochloride. Nineteen suppliers are listed for this compound.

Summary for fingolimod hydrochloride

International Patents:	246
US Patents:	4
Tradenames:	2
Applicants:	18
NDAs:	19
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	139
Clinical Trials:	74
Patent Applications:	829
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fingolimod hydrochloride
What excipients (inactive ingredients) are in fingolimod hydrochloride?	fingolimod hydrochloride excipients list
DailyMed Link:	fingolimod hydrochloride at DailyMed

Recent Clinical Trials for fingolimod hydrochloride

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

Sponsor	Phase
The Methodist Hospital Research Institute	Phase 2
General Hospital of Shenyang Military Region	Phase 4
Hoffmann-La Roche	Phase 3

See all fingolimod hydrochloride clinical trials

Pharmacology for fingolimod hydrochloride

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

Medical Subject Heading (MeSH) Categories for fingolimod hydrochloride

Immunosuppressive Agents

Paragraph IV (Patent) Challenges for FINGOLIMOD HYDROCHLORIDE

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 fingolimod hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Accord Hlthcare	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	207991-001	Oct 28, 2020	AB	RX	No	No
Hetero Labs Ltd V	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	207933-001	May 18, 2020	AB	RX	No	No
Novartis	GILENYA	fingolimod hydrochloride	CAPSULE;ORAL	022527-001	Sep 21, 2010	AB	RX	Yes	Yes
Prinston Inc	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	208003-001	Sep 7, 2022	AB	RX	No	No
Sun Pharm	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	208014-001	Dec 4, 2019	AB	RX	No	No
Zydus Pharms	FINGOLIMOD HYDROCHLORIDE	fingolimod hydrochloride	CAPSULE;ORAL	207994-001	Oct 14, 2020	AB	RX	No	No

Expired US Patents for fingolimod hydrochloride

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 fingolimod hydrochloride

Country	Patent Number	Title	Estimated Expiration
Chile	2011000450	Proceso para preparar una composicion farmaceutica que comprende a) mezclar un agonista del receptor s1p, seleccionado de 2-amino-2-[2-(4-octilfenil)etil]propano-1,3-diol y una sal del mismo, con un alcohol de azucar; b) moler y/o granular la mezcla; y c) mezclar la mezcla con un lubricante (divisional solicitud 745-2004).
World Intellectual Property Organization (WIPO)	2008000419
Argentina	078781	COMPOSICION FARMACEUTICA SOLIDA ADECUADA PARA ADMINISTRACION ORAL
Canada	2653569	MODULATEURS DU RECEPTEUR DE LA S1P DESTINES AU TRAITEMENT DELA SCLEROSE EN PLAQUES (S1P RECEPTOR MODULATORS FOR TREATING MULTIPLE SCLEROSIS)
Cyprus	1117071
Mexico	2012003740	REGIMEN DE DOSIFICACION DE UN MODULADOR DEL RECEPTOR S1P. (DOSAGE REGIMEN OF AN S1P RECEPTOR MODULATOR.)

Supplementary Protection Certificates for fingolimod hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0627406	C300488	Netherlands		PRODUCT NAME: FINGOLIMOD, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER FINGOLIMOD HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/11/677/001-004 20110317
1613288	PA2011010,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
1613288	2011C/030	Belgium		PRODUCT NAME: FINGOLIMOD; AUTHORISATION NUMBER AND DATE: EU/1/11/677/001 20110322
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	C01613288/01	Switzerland		PRODUCT NAME: FINGOLOMOD; REGISTRATION NO/DATE: SWISSMEDIC 60916 20110103
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