Global pharma major Lupin Limited (Lupin) announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for valbenazine capsules, 40 mg and 80 mg, 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 (Ingrezza) had estimated annual sales of USD 1,621 million in the US (IQVIA MAT February 2024).
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.