In a press release dated Oct. 31, 2022, Glenmark Pharmaceuticals USA announced that it has introduced fingolimod capsules, 0.5mg to the U.S. market. An AB-rated generic to Gilenya^® (Novartis), it is taken once a day to treat relapsing forms of multiple sclerosis (MS). After a long series of legal actions, several other generic companies also have approval for fingolimod 0.5mg capsules from the U.S. Food and Drug Administration (FDA). Mainly due to settlement agreements with Novartis, however, no other company has released its product; and their distribution, launch, and pricing plans are not known. No generics are available for Gilenya’s 0.25mg strength capsules.

At a Glance

• Brand Drug: Gilenya 0.5mg capsule (fingolimod – Novartis)
• Indication: to treatrelapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease
• Generic Manufacturers: Glenmark and others
• Launch Date: October 2022
• Dosage Forms Available: 0.5mg capsules
• Annual U.S. Sales: For the 12 months that ended on Sept. 30, 2020, IQVIA estimates that Gilenya earned about $1.8 billion in U.S. sales.
• The recommended daily dose of fingolimod for adults and pediatric patients who weigh more than 40kg (88 pounds) is 0.5mg. For patients who are between the ages of 10 years and 17 years old and who weigh 40kg or less, the dose is 0.25mg.
• Although about a dozen other companies have FDA approval for 0.5mg fingolimod capsules, no information currently is available about their launch plans. Many of the companies have confidential legal settlement agreements with Novartis that will allow them to sell generics in the U.S. before the last applicable patent on Gilenya 0.5mg capsules expires in December 2027.