Lupin Unveils Game-Changing Risperidone Injectable with Exclusive CGT in the U.S.

Lupin's New Long-Acting Injectable: A Milestone in Pharma

Lupin Limited, a leading global pharmaceutical company based in Mumbai, has made a significant advancement with the launch of its long-acting injectable Risperidone. This innovative drug is now available in the U.S. and showcases Lupin's proprietary technology, PrecisionSphere™, which offers enhanced treatment options for patients.

About Risperidone

The newly launched Risperidone extended-release injectable suspension comes in three concentrations: 25 mg, 37.5 mg, and 50 mg per vial. Designed as a single-dose vial, it boasts a unique feature: a 180-day CGT exclusivity granted by the U.S. Food and Drug Administration (FDA). This exclusivity reflects a strong commitment from Lupin toward developing complex injectable solutions, emphasizing the growing need for advanced treatment options in mental health.

Innovative Delivery Platform: PrecisionSphere™

Lupin's PrecisionSphere™ technology, developed through its subsidiary Nanomi B.V., addresses common challenges associated with delivering medications via injections. The key to its efficacy lies in the creation of uniform microspheres that enable slow and steady drug release over weeks to months. This method ensures not just improved patient compliance, but also maintains consistent drug levels in the bloodstream, thereby enhancing overall therapeutic benefits.

Rationale Behind This Development

As mental health issues rise globally, the demand for effective treatment options continues to escalate. The launch of Risperidone is timely and crucial, as it caters to individuals suffering from schizophrenia and bipolar disorders. The product is bioequivalent to the reference drug, Risperdal Consta®, which has generated an estimated sales value of approximately USD 187 million in the U.S. market according to IQVIA data from September 2025.

Lupin's Vision and Future Plans

Lupin's expansion into long-acting injectables is part of a broader strategy to diversify its product portfolio. Spiro Gavaris, President of U.S. Generics at Lupin, emphasized that the launch symbolizes significant progress in meeting the needs of patients requiring complex injectables. The company views its proprietary technology as a vehicle for fostering collaborations with other firms seeking to enhance their product offerings.

Dr. Fabrice Egros, President of Corporate Development at Lupin, also expressed optimism about the future potential of long-acting injectables. With a proven record in successful partnerships, Lupin is well-positioned to bolster global access to advanced therapies that can make a difference for patients.

About Lupin Limited

With a comprehensive portfolio ranging from generic medications to biotechnology products, Lupin is recognized for its commitment to improving health outcomes worldwide. The firm operates over 15 state-of-the-art manufacturing facilities and 7 research centers globally, employing a dedicated team of around 24,000 professionals. It aims to leverage its expertise not only in developing groundbreaking medications but also in exploring new markets for its technology-driven products.

In conclusion, the launch of the long-acting injectable Risperidone by Lupin Limited marks a critical step forward in the pharmaceutical landscape, showcasing innovation and a strong dedication to mental health treatments. Patients can now look forward to better access to advanced care, aligning with the ongoing push for improvement in healthcare delivery.