Chennai-based Orchid Pharma has received final approval from the US Food and Drug Administration (USFDA) for its generic version of rasagiline tablets used in the treatment of Parkinson’s disease.
The nod from the USFDA for the first-to-file abbreviated new drug application with shared 180-day marketing exclusivity is for the strengths of 0.5 mg and 1 mg, Orchid Pharma said in a BSE filing.
“Orchid expects to launch this products in the fourth quarter of fiscal 2016-17,” it added.
Rasagiline mesylate tablets are indicated for the treatment of signs and symptoms of idiopathic Parkinson’s disease.
“With a market size of over $300 million and limited generic competition,” Orchid said, adding that it “hopes to garner a decent market share from this product launch”.
Rasagiline tablets are sold under the brand AZILECT by Teva Pharmaceutical Industries.
Orchid Pharma stock was trading up 12.18% at Rs 41.90 during the afternoon trade on BSE.