Updated on 14 April 2016
Chennai-based Pharma major, Orchid Pharma has received final approval from the US FDA for its ANDA (Abbreviated New Drug Application) for Rasagiline Tablets 0.5 mg and 1 mg. This product is a FTF (First-to-file) application with a shared 180-day exclusivity for Orchid.
Orchid expects to launch this product in Q4 of FY 16-17. Rasagiline Mesylate Tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease.
With a market size of over US$ 300 million and limited generic competition, Orchid hopes to garner a decent market share from this product launch.