The approved ANDA is a generic equivalent of Xywav Oral Solution of Jazz Pharmaceuticals Ireland. This product will be manufactured at Lupin's Somerset facility in the US.
Lupin is exclusive first-to-file and may be eligible to receive a 180-day exclusivity period at product launch.
The net product sales for Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution were $958.4 million for the year ending December 2022 and $604.3 million for the first six months of 2023.
Xywav (calcium, magnesium, potassium, and sodium oxybates) is a central nervous system (CNS) depressant indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
Mumbai-based Lupin is an innovation-led transnational pharmaceutical company. It develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
The company reported consolidated net profit of Rs 452.26 crore in Q1 FY24 compared with net loss of Rs 89.08 crore in Q1 FY23. Revenue from operations jumped 31.58% YoY to Rs 4,742.12 crore in Q1 FY24.
Shares of Lupin rose 0.61% to Rs 1178.95 on 5 October 2023.