Pharsight

Gilenya is owned by Novartis.

Gilenya contains Fingolimod Hydrochloride.

Gilenya has a total of 7 drug patents out of which 0 drug patents have expired.

Gilenya was authorised for market use on 21 September, 2010.

Gilenya is available in capsule;oral dosage forms.

Gilenya can be used as treatment of relapsing remitting multiple sclerosis by determining varicella zoster virus (vzv) status and vaccinating prior to commencing treatment, treatment of relapsing-remitting sclerosis (ms), treatment of multiple sclerosis in the pediatric patient population with 0.25 mg fingolimod.

The generics of Gilenya are possible to be released after 30 September, 2032.

Application	Filing Date	Opposition Party	Legal Status
EP15177166A	2023-01-23	Dr. Schön, Neymeyr & Partner Patentanwälte mbB	Granted and Under Opposition
EP15177166A	2023-01-13	BIOGARAN	Granted and Under Opposition
EP15177166A	2023-01-09	STADA Arzneimittel AG	Granted and Under Opposition
EP15177166A	2023-01-02	Bausch Health Ireland Limited	Granted and Under Opposition
EP15177166A	2022-12-06	Vivanta Generics s.r.o. / MSN Labratories Private Ltd.	Granted and Under Opposition
EP15177166A	2022-12-05	Heumann Pharma GmbH & Co. Generica KG	Granted and Under Opposition
EP15177166A	2022-12-01	Accord Healthcare Ltd	Granted and Under Opposition
EP15177166A	2022-11-21	A-med GmbH	Granted and Under Opposition
EP15177166A	2022-11-09	RAFARM S.A.	Granted and Under Opposition
EP15177166A	2022-11-04	Genepharm S.A.	Granted and Under Opposition
EP15177166A	2022-10-20	Elpen Pharmaceutical Co. Inc.	Granted and Under Opposition
EP15177166A	2022-10-12	Teva Pharmaceutical Industries Ltd	Granted and Under Opposition
EP15177166A	2022-10-12	Glenmark Pharmaceuticals Europe Ltd.	Granted and Under Opposition
EP15177166A	2022-10-12	Generics [UK] Limited	Granted and Under Opposition
EP15177166A	2022-10-12	Zentiva k.s.	Granted and Under Opposition
EP15177166A	2022-10-12	PHARMATHEN S.A.	Granted and Under Opposition

Patent	Proceeding Filing Date	Status	Respondent	Petitioner
US9187405	August, 2017	Terminated-Other
US9187405	August, 2017	FWD Entered	Novartis Pharmaceuticals Corporation	Actavis Elizabeth LLC
US9187405	June, 2017	FWD Entered	Novartis AG	Argentum Pharmaceuticals LLC
US9187405	February, 2017	FWD Entered	Novartis AG	Apotex Inc.
US8324283	December, 2014	FWD Entered	Novartis AG	Apotex, Inc.
US8324283	May, 2014	FWD Entered	Novartis AG	TORRENT PHARMACEUTICALS LIMITED

Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8324283	NOVARTIS	Solid pharmaceutical compositions comprising a SIP receptor agonist and a sugar alcohol	Mar, 2026 (2 years from now)
US8324283 (Pediatric)	NOVARTIS	Solid pharmaceutical compositions comprising a SIP receptor agonist and a sugar alcohol	Sep, 2026 (3 years from now)
US9187405	NOVARTIS	S1P receptor modulators for treating relasping-remitting multiple sclerosis	Jun, 2027 (4 years from now)
US10543179	NOVARTIS	Dosage regimen of an S1P receptor modulator	Dec, 2027 (4 years from now)
US9187405 (Pediatric)	NOVARTIS	S1P receptor modulators for treating relasping-remitting multiple sclerosis	Dec, 2027 (4 years from now)
US9592208	NOVARTIS	Formulations comprising 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol	Mar, 2032 (8 years from now)
US9592208 (Pediatric)	NOVARTIS	Formulations comprising 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol	Sep, 2032 (9 years from now)

Drugs and Companies using FINGOLIMOD HYDROCHLORIDE ingredient

Market Authorisation Date: 21 September, 2010

Treatment: Treatment of relapsing-remitting sclerosis (ms); Treatment of relapsing remitting multiple sclerosis by determining varicella zoster virus (vzv) status and vaccinating prior to commencing treatment; T...

Dosage: CAPSULE;ORAL