Lupin Launches Risperidone Injectable with 180-Day CGT Exclusivity in U.S.

Lupin Limited has announced the launch of Risperidone for extended-release injectable suspension in the United States. The product is available in 25 mg, 37.5 mg, and 50 mg single-dose vials. This launch follows the recent approval from the United States Food and Drug Administration (U.S. FDA) and includes a 180-day Competitive Generic Therapy (CGT) exclusivity. This is the first product utilizing Lupin’s proprietary PrecisionSphere™ technology, developed by its subsidiary Nanomi B.V.

The Risperidone injectable is bioequivalent and therapeutically equivalent to the reference listed drug, Risperdal Consta®. It is indicated for the treatment of schizophrenia in adults and as monotherapy or adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. The reference drug has estimated sales of USD 187 million in the U.S. for the combined doses of 25 mg, 37.5 mg, and 50 mg, according to IQVIA MAT September 2025 data.

The PrecisionSphere™ platform developed by Nanomi B.V. creates uniform microspheres that deliver extended-release profiles ranging from weeks to months. This technology allows for superior injectability through smaller needles and consistent drug concentrations. Lupin is expanding the reach of this technology by fostering collaborations with companies interested in extending their product lifecycles.

The launch of Risperidone represents a significant milestone for Lupin, demonstrating its capability in delivering complex injectables to the market. The product’s introduction highlights Lupin’s commitment to expanding its portfolio of differentiated, complex products and developing novel long-acting injectables across diverse therapeutic areas.

The product launch follows the recent approval by the U.S. FDA, granting Lupin a 180-day CGT exclusivity period. This exclusivity is part of the U.S. FDA’s initiative to encourage the development of generic drugs and increase market competition.

Lupin Limited is a global pharmaceutical leader specializing in branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company operates in over 100 markets and maintains a strong presence in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin is committed to improving patient health outcomes through its subsidiaries, including Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.