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Gilenya generic

Gilenya is an oral drug owned by Novartis. The active ingredient in this medication is fingolimod hydrochloride. Market authorization for Gilenya was granted on 21 September, 2010. It is available to patients in the form of a capsule.

When will Gilenya generic be available?

The generics of Gilenya are not likely to be available until after 30 September, 2032. This is due to the patents held by Novartis, with the last one set to expire on this date.

Gilenya uses

Gilenya is used for the treatment of multiple sclerosis in pediatric patients and in people diagnosed with relapsing-remitting sclerosis. It is effective due to its fingolimod hydrochloride content, which helps manage relapses and slow down the progression of physical disability. Before commencing the treatment, the patient's varicella zoster virus (VZV) status is checked and vaccination is performed if necessary.

Gilenya patent expiration

There are 7 patents on Gilenya held by Novartis, with none having expired so far. These include patents on compositions, modulators for treating multiple sclerosis, dosage regimen, and specific formulations. The most recent patent, pertaining to a propen-1,3-diol formulation will expire on 30 September, 2032, which could prompt the release of Gilenya generic versions. Below are the details of the patent:

EPO Oppostions filed on Gilenya

Litigations filed on Gilenya

Gilenya dosage

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