Lupin has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution, 0.5 g/mL, to market a generic equivalent of Xywav Oral Solution, 0.5 g/mL 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 (RLD Xywav) were $958.4 million for the year ending December 2022 and $604.3 million for the first six months of 2023
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.
