| Drug Patent Number | Company | Drug Patent Title | Drug Patent Expiry | Activity Alert |
|---|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | ||||
| US5604229 | NOVARTIS | 2-amino-1,3-propanediol compound and immunosuppressant |
Feb, 2019
(5 years ago) | |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | ||||
| US6004565 | NOVARTIS | Compositions and methods of using compositions with accelerated lymphocyte homing immunosuppressive properties |
Sep, 2017
(6 years ago) | |
|
US5604229 (Pediatric) | NOVARTIS | 2-amino-1,3-propanediol compound and immunosuppressant |
Aug, 2019
(4 years ago) | |
| US8324283 | NOVARTIS | Solid pharmaceutical compositions comprising a SIP receptor agonist and a sugar alcohol |
Mar, 2026
(1 year, 10 months from now) | |
|
US8324283 (Pediatric) | NOVARTIS | Solid pharmaceutical compositions comprising a SIP receptor agonist and a sugar alcohol |
Sep, 2026
(2 years from now) | |
| US9187405 | NOVARTIS | S1P receptor modulators for treating relasping-remitting multiple sclerosis |
Jun, 2027
(3 years from now) | |
| US10543179 | NOVARTIS | Dosage regimen of an S1P receptor modulator |
Dec, 2027
(3 years from now) | |
|
US9187405 (Pediatric) | NOVARTIS | S1P receptor modulators for treating relasping-remitting multiple sclerosis |
Dec, 2027
(3 years from now) | |
| US9592208 | NOVARTIS | Formulations comprising 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol |
Mar, 2032
(7 years from now) | |
|
US9592208 (Pediatric) | NOVARTIS | Formulations comprising 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol |
Sep, 2032
(8 years from now) | |
Gilenya is owned by Novartis.
Gilenya contains Fingolimod Hydrochloride.
Gilenya has a total of 10 drug patents out of which 3 drug patents have expired.
Expired drug patents of Gilenya are:
- US6004565
- US5604229*PED
- US5604229
Gilenya was authorised for market use on 11 May, 2018.
Gilenya is available in capsule;oral dosage forms.
Gilenya can be used as treatment of autoimmune disease, treatment of relapsing remitting multiple sclerosis by determining varicella zoster virus (vzv) status and vaccinating prior to commencing treatment, treatment of multiple sclerosis in the pediatric patient population with 0.25 mg fingolimod, treatment of relapsing-remitting sclerosis (ms).
Drug patent challenges can be filed against Gilenya from 11 November, 2020.
The generics of Gilenya are possible to be released after 30 September, 2032.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Strength(NS) | May 11, 2021 |
| New Patient Population(NPP) | May 11, 2021 |
| Pediatric Exclusivity(PED) | Nov 11, 2021 |
| M(M-106) | Jul 20, 2014 |
| New Chemical Entity Exclusivity(NCE) | Sep 21, 2015 |
Drugs and Companies using FINGOLIMOD HYDROCHLORIDE ingredient
NCE-1 date: 11 November, 2020
Market Authorisation Date: 11 May, 2018
Treatment: Treatment of autoimmune disease; Treatment of relapsing-remitting sclerosis (ms); Treatment of relapsing remitting multiple sclerosis by determining varicella zoster virus (vzv) status and vaccinating...
Dosage: CAPSULE;ORAL
GILENYA family patents
