Strides Shasun’s subsidiary, Strides Pharma Global, Singapore has received tentative approval from the United States Food & Drug Administration (USFDA) for its Para IV filing of Fingolimod Capsules, 0.5 mg. The product can be launched on generic market formation expected in February 2019, with a potential 180 day exclusivity.
Fingolimod Capsules is used for treatment of adult patients with relapsing forms of multiple sclerosis. The product is currently sold by Novartis under the brand name GILENYA. According to IMS data, the US market for Fingolimod Capsules is around $2 billion. Fingolimod Capsules registered a healthy CAGR of 10 % over last 5 years as per IMS December 2016 MAT data.
Strides Shasun (formerly known as Strides Arcolab) is a global pharmaceutical company headquartered in Bangalore, India that develops and manufactures wide range of IP-lead niche pharmaceutical products with an emphasis on sterile injectables.