The product is marketed for the treatment of Relapsing-Remitting Multiple Sclerosis. If the abbreviated new drug application is approved, the firm will be eligible for 180-day first-to-file exclusivity under Hatch-Waxman.
The product is to be launched in the first quarter of 2017, assuming the Paragraph IV challenge is successful and adheres to customary Hatch-Waxman litigation timelines.
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