Lupin launches first PrecisionSphere long-acting injectable in US

Lupin Limited announced the launch of Risperidone for extended-release injectable suspension in 25 mg, 37.5 mg, and 50 mg single-dose vials in the U.S., following recent FDA approval. This product is the first from Lupin to utilize its proprietary PrecisionSphere™ long-acting injectable (LAI) platform, developed by its subsidiary Nanomi B.V. The launch includes 180-day CGT exclusivity in the U.S.

The Risperidone injectable is bioequivalent and therapeutically equivalent to Risperdal Consta® Long-Acting Injection, indicated for treating schizophrenia and bipolar I disorder in adults. The reference listed drug (RLD) Risperdal Consta® recorded estimated sales of $187 million combined for its 25 mg, 37.5 mg, and 50 mg dosages in the U.S. (IQVIA MAT September 2025).

PrecisionSphere™ technology delivers uniform microspheres for extended-release profiles over weeks to months, aiming for superior injectability and consistent drug concentrations. Lupin intends to expand the reach of this technology through internal pipeline development and strategic collaborations.