MUMBAI, India, and NAPLES, Fla. — Lupin has launched its first long-acting injectable developed with its proprietary PrecisionSphere technology, introducing risperidone for extended-release injectable suspension in 25 mg, 37.5 mg, and 50 mg single-dose vials. The product, which just received U.S. Food and Drug Administration approval, enters the market with 180-day CGT exclusivity.
The launch marks Nanomi B.V.'s first commercial product, a subsidiary of Lupin, using its PrecisionSphere platform to create uniform microspheres for extended-release drug delivery that lasts from weeks to months. This technology allows for easier injection with smaller needles and more consistent drug concentrations.
“The launch of Risperidone marks a significant milestone, demonstrating Lupin’s expertise in delivering complex injectables to market, validating the capabilities of the PrecisionSphere LAI technology platform," said Spiro Gavaris, president of U.S. generics at Lupin. "It highlights our commitment to expanding our portfolio of differentiated, complex products, marking a significant step forward in our pursuit of developing novel long-acting injectables across diverse therapeutic areas.”
“PrecisionSphere’s proven capabilities, combined with our track record of successful partnerships, uniquely position us to expand global access to advanced long-acting injectable treatments," added Dr. Fabrice Egros, president of corporate development. “By leveraging our in-house expertise and alliance management, we are ready to expand patient access to advanced LAI treatments through our growing internal pipeline but also by forming new global strategic collaborations with companies that could benefit from longer-acting formulations for their products."
Lupin’s risperidone injectable is bioequivalent and therapeutically equivalent to Risperdal Consta and is indicated for adults with schizophrenia and for maintenance treatment of bipolar I disorder as monotherapy or with other medications like lithium or valproate. Combined U.S. sales for the reference product across all three strengths totaled an estimated $187 million for the 12 months ending September 2025, according to IQVIA.
Lupin distributes products in over 100 markets and operates 15 manufacturing facilities along with 7 research centers worldwide.
