 "Orchid Pharma gets shared 180-day exclusivity rights for Parkinson's drug in US")
Orchid Pharma Ltd (formerly known as Orchid Chemicals & Pharmaceuticals Ltd) has received final approval from the US Food & Drug Administration (FDA) for its rasagiline tablets 0.5 mg and 1 mg, with 180-day shared exclusivity for the company. Orchid Pharma expects to launch rasagiline mesylate tablets, which are indicated for treatment of signs and symptoms of idiopathic Parkinson's disease, in Q4 of FY16-17.
“The company has received final approval from US FDA for its abbreviated new drug application (ANDA) for rasagiline tablets (0.5 mg and 1 mg). This product is a first-to-file application with a shared 180-day exclusivity for Orchid,” said Orchid Pharma press release.
With a market size of over $ 300 million and limited generic competition, Orchid said it expects to garner a decent market share from this product launch.
“The company has received final approval from US FDA for its abbreviated new drug application (ANDA) for rasagiline tablets (0.5 mg and 1 mg). This product is a first-to-file application with a shared 180-day exclusivity for Orchid,” said Orchid Pharma press release.
With a market size of over $ 300 million and limited generic competition, Orchid said it expects to garner a decent market share from this product launch.