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 FY16-17.
Rasagiline Mesylate Tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. With a market size of over $ 300 million and limited generic competition, Orchid hopes to garner a decent market share from this product launch.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1675.20 |
| Dr. Reddys Lab | 1235.40 |
| Cipla | 1238.30 |
| Zydus Lifesciences | 942.55 |
| Lupin | 2324.25 |
| View more.. | |
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