Fingolimod Hydrochloride Patent Expiration

Fingolimod Hydrochloride is Used for treating autoimmune diseases and multiple sclerosis, including relapsing-remitting and pediatric patients. It was first introduced by Novartis Pharmaceuticals Corp in its drug Gilenya on Sep 21, 2010. 18 different companies have introduced drugs containing Fingolimod Hydrochloride.


Fingolimod Hydrochloride Patents

Given below is the list of patents protecting Fingolimod Hydrochloride, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Gilenya US9592208

(Pediatric)

Formulations comprising 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol Sep 30, 2032 Novartis
Gilenya US9592208 Formulations comprising 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol Mar 30, 2032 Novartis
Gilenya US10543179 Dosage regimen of an S1P receptor modulator Dec 25, 2027 Novartis
Gilenya US9187405

(Pediatric)

S1P receptor modulators for treating relasping-remitting multiple sclerosis Dec 25, 2027 Novartis
Gilenya US9187405 S1P receptor modulators for treating relasping-remitting multiple sclerosis Jun 25, 2027 Novartis
Gilenya US8324283

(Pediatric)

Solid pharmaceutical compositions comprising a SIP receptor agonist and a sugar alcohol Sep 29, 2026 Novartis
Gilenya US8324283 Solid pharmaceutical compositions comprising a SIP receptor agonist and a sugar alcohol Mar 29, 2026 Novartis
Gilenya US5604229

(Pediatric)

2-amino-1,3-propanediol compound and immunosuppressant Aug 18, 2019

(Expired)

Novartis
Gilenya US5604229 2-amino-1,3-propanediol compound and immunosuppressant Feb 18, 2019

(Expired)

Novartis
Gilenya US6004565 Compositions and methods of using compositions with accelerated lymphocyte homing immunosuppressive properties Sep 23, 2017

(Expired)

Novartis
Gilenya US5604229 2-amino-1,3-propanediol compound and immunosuppressant Feb 18, 2014

(Expired)

Novartis



Fingolimod Hydrochloride's Family Patents

Family Patents

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Fingolimod Hydrochloride Generic API Manufacturers

Several generic applications have been filed for Fingolimod Hydrochloride. The first generic version for Fingolimod Hydrochloride was by Biocon Ltd and was approved on Dec 4, 2019. And the latest generic version is by Aurobindo Pharma Ltd and was approved on Feb 28, 2024.

Given below is the list of companies who have filed for Fingolimod Hydrochloride generic, along with the locations of their manufacturing plants worldwide.