Lupin gets provisional green light from USFDA for its oral solution

Mumbai: Lupin Limited (Lupin) has announced that it has received a provisional approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) concerning a generic equivalent of Xywav® Oral Solution, 0.5 g/mL, by Jazz Pharmaceuticals Ireland Limited.

This medication, known as Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution, 0.5 g/mL, will be produced at Lupin's facility in Somerset, United States.

Lupin holds the exclusive position as the first company to file for this generic version and may have the opportunity to enjoy a 180-day exclusivity period upon product launch.

In the year ending December 2022, the net product sales for Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution (the Reference Listed Drug Xywav®) amounted to USD 958.4 million, and for the first half of 2023, they were USD 604.3 million.