Lupin receives tentative FDA nod for 2 generics

Lupin has received tentative approval from the Food and Drug Administration for two generics.

The first tentative nod is for calcium, magnesium, potassium, and sodium oxybates oral solution, 0.5 g/ml, which is a generic of Jazz Pharmaceuticals Ireland’s Xywav.

This product will be manufactured at Lupin’s Somerset facility in the United States.

Lupin is exclusive first-to-file and may be eligible to receive a 180-day exclusivity period at product launch.

[Read more: Lupin receives FDA OK for generic Banzel]

The net product sales for calcium, magnesium, potassium, and sodium oxybates oral solution (Xywav) were $958.4 million for the year ending December 2022 and $604.3 million for the first six months of 2023, per Lupin.

Lupin also has received tentative approval from the FDA for apalutamide tablets, 60 mg, which is a generic of Janssen Biotech’s Erleada. This product will be manufactured at Lupin’s Pithampur facility in India.

Apalutamide tablets, 60 mg, (Erleada) had a market value of roughly  $1.2 billion, per IQVIA July 2023 data.