Bangalore: Strides Shasun Limited has announced that its subsidiary Strides Pharma Global Pte Limited, 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.
According to IMS data, the US market for Fingolimod Capsules is approximately USD 2 Billion. Fingolimod Capsules registered a healthy CAGR of 10 percent over last 5 years (IMS December 2016 MAT data). Based upon available information, Company believes it is amongst the first wave of ANDA applicants for Fingolimod with a Paragraph IV certification. On receiving full approval, the product will be manufactured at the Company’s Oral dosage facility at Bangalore and marketed by its subsidiary in USA, Strides Pharma Inc.
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®.
Strides Shasun has global manufacturing footprint with 13 manufacturing facilities spread across three continents including 5 US FDA approved facilities and 8 facilities for the emerging markets. The Company has three dedicated R&D facilities in India with global filing capabilities and a strong commercial footprint across 85 countries.