Lupin Limited has announced the launch of Risperidone for Extended-Release Injectable Suspension in the United States, strengthening its presence in the long-acting injectable segment. The product is available in 25 mg, 37.5 mg, and 50 mg single-dose vials and has received 180-day Competitive Generic Therapy (CGT) exclusivity after approval from the U.S. Food and Drug Administration (FDA).
This launch marks an important milestone as it is the first product developed using Lupin’s proprietary PrecisionSphere™ technology, a long-acting injectable (LAI) platform created by its subsidiary, Nanomi B.V.
Innovative Drug Delivery Approach
PrecisionSphere™ technology is designed to enable the controlled and sustained release of medication over extended periods. By using uniform microspheres, the platform ensures:
- Consistent drug concentration levels
- Reduced dosing frequency for improved patient adherence
- Enhanced ease of administration with smaller needles
The technology has demonstrated strong safety and efficacy, making it a promising advancement in long-term treatment solutions.
Product Overview
Risperidone for Extended-Release Injectable Suspension is bioequivalent and therapeutically equivalent to Risperdal Consta® Long-Acting Injection. It is indicated for:
- Treatment of schizophrenia in adults
- Maintenance treatment of bipolar I disorder, either as monotherapy or in combination with lithium or valproate
The reference product has recorded estimated U.S. sales of $187 million (IQVIA MAT September 2025), reflecting its established demand in the market.
Strengthening Market Position
With this launch, Lupin continues to expand its portfolio of complex generics and differentiated pharmaceutical products. The company is also focused on leveraging its PrecisionSphere™ platform through strategic collaborations to enhance product lifecycle management and improve patient access to advanced therapies.
About Lupin
Headquartered in Mumbai, Lupin Limited is a global pharmaceutical company with operations in over 100 markets. Its product portfolio spans branded and generic formulations, biotechnology products, and active pharmaceutical ingredients.
The company has a strong presence across key therapeutic areas, including respiratory, cardiovascular, anti-diabetic, central nervous system, gastrointestinal, and women’s health. Supported by 15 manufacturing facilities and 7 research centers worldwide, Lupin remains committed to innovation and better healthcare outcomes.
Conclusion
The launch of Risperidone for Extended-Release Injectable Suspension highlights Lupin’s continued focus on innovation in drug delivery. Backed by its PrecisionSphere™ platform, the company is well-positioned to advance long-acting injectable therapies and contribute to improved patient care globally.
Sign in to leave a comment.