Global pharma major Lupin Limited on Monday announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Valbenazine Capsules, 40 mg and 80 mg.
According to the company’s statement, the approval has been granted to market a generic equivalent of Ingrezza Capsules, 40 mg and 80 mg, of Neurocrine Biosciences, Inc.
Lupin is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity. The product will be manufactured at Lupin’s Nagpur facility in India.
Valbenazine Capsules, 40 mg and 80 mg (RLD Ingrezza) had estimated annual sales of USD 1621 million in the U.S. (IQVIA MAT February 2024).