Lupin Secures FDA Approval for Long-Acting Injectable Risperidone in the U.S.

Lupin's FDA Approval for Long-Acting Injectable Risperidone

In a landmark achievement, Lupin Limited, a renowned global pharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has granted approval for its long-acting injectable formulation of risperidone. The product, which will be available in 25 mg, 37.5 mg, and 50 mg vials, represents the first release from Lupin’s innovative Nanomi platform, and includes 180 days of CGT exclusivity.

This injectable suspension is designed for single-dose administration, showcasing Lupin's commitment to advancing patient care through innovative medication delivery systems. The company has revealed that the technology utilized in this formulation is patented by Nanomi B.V., a subsidiary dedicated to the development of long-acting injectable drugs aimed at enhancing patient health outcomes.

Vinita Gupta, CEO of Lupin, expressed her satisfaction regarding this significant milestone, stating, “We are thrilled with the approval of our first product from the Nanomi LAI platform. This achievement reflects the hard work of our R&D and operations teams in developing complex injectable products and underscores our commitment to broadening access to these essential medicines globally.”

The Nanomi platform's unique technology employs a particle control system that generates uniform microspheres, allowing for sustained drug release ranging from several weeks to months. This methodology not only simplifies administration via finer needles but also promises a consistent drug concentration, critical for patient adherence and treatment efficiency.

Additionally, Dr. Shahin Fesharaki, Chief Scientific Officer of Lupin, highlighted the importance of this FDA approval as a testament to the capabilities of the Nanomi LAI platform. He affirmed, “This milestone validates the multidisciplinary efforts of our teams and marks a crucial step toward the development of new long-acting injectable medications across various therapeutic areas.”

Product Overview

The long-acting injectable risperidone is bioequivalent to the reference drug, Risperdal Consta®, and is indicated for the treatment of schizophrenia. It can also be used as either monotherapy or adjunct therapy with lithium or valproate for the maintenance treatment of bipolar disorder type I. In 2025, sales of Risperdal Consta® were estimated to be around $190 million annually in the U.S., showcasing the potential market impact of Lupin's new offering.

About Lupin

Lupin Limited is a leading global pharmaceutical manufacturer based in Mumbai, India, serving over 100 markets worldwide. The company specializes in a wide range of pharmaceuticals, including branded and generic products, complex generics, biotechnology products, and active pharmaceutical ingredients. With a stronghold in key therapeutic areas such as respiratory, cardiovascular, diabetes, infections, gastroenterology, central nervous system, and women's health, Lupin is committed to improving patient health outcomes through innovative solutions. They operate 15 state-of-the-art manufacturing plants and 7 research centers globally, employing over 24,000 professionals dedicated to this mission.

For further information, visit Lupin's official website or follow them on LinkedIn. More details about Nanomi can be found at Nanomi's website and their LinkedIn page as well.

Disclaimer: Risperdal Consta® is a registered trademark of Johnson & Johnson.