Lupin gets tentative USFDA nod for generic equivalent of Xywav Oral Solution
Lupin is exclusive first-to-file and may be eligible to receive a 180-day exclusivity period at product launch.
Mumbai: Global pharma major Lupin Limited has announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) 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 Limited.
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 USD 958.4 million for the year ending December 2022 and USD 604.3 million for the first six months of 2023.
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 U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.
The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 7.9% of its revenue in research and development in FY23.
Lupin has 15 manufacturing sites, 7 research centers.
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