09Apr 2024
Lupin Secures FDA Approval for Generic Valbenazine Capsules, Gains 180-Day Exclusivity

Lupin Secures FDA Approval for Generic Valbenazine Capsules, Gains 180-Day Exclusivity

Lupin Limited has secured approval from the U.S. Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) concerning Valbenazine Capsules in 40 mg and 80 mg strengths. This approval allows Lupin to market a generic version of Neurocrine Biosciences, Inc.'s Ingrezza® Capsules. As one of the initial ANDA applicants, Lupin is entitled to 180 days of shared generic exclusivity. Ingrezza® recorded estimated annual sales of USD 1.621 billion in the U.S. as of February 2024, according to IQVIA.

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