September 3, 2025 – Mumbai & Naples – Lupin Limited announced U.S. FDA approval for its Risperidone extended-release injectable suspension, the first product developed using its proprietary Nanomi long-acting injectable (LAI) technology platform. The approval grants 180-day Competitive Generic Therapy (CGT) exclusivity, marking a major milestone for the company’s entry into complex injectables in the United States.
Science Significance
This approval validates Nanomi’s particle control technology, which enables uniform microspheres to deliver extended-release profiles from weeks to months. The innovation offers superior injectability through smaller needles and consistent drug concentrations, enhancing both patient experience and clinical outcomes. By leveraging this platform, Lupin aims to expand into novel LAIs across multiple therapeutic areas, offering lifecycle management opportunities for existing drugs and creating new therapeutic options.
Risperidone LAI is bioequivalent to Risperdal Consta®, the reference listed drug and is indicated for the treatment of schizophrenia and bipolar I disorder. The approval underscores Lupin’s growing R&D capabilities in central nervous system (CNS) disorders and its strategic pivot toward complex, specialty products.
Regulatory Significance
The first-cycle approval from the U.S. FDA is a strong regulatory endorsement of Lupin’s Nanomi platform. The CGT exclusivity grants Lupin a six-month window of market protection, ensuring competitive advantage in the U.S. generics landscape. FDA’s decision highlights confidence in the safety, efficacy, and manufacturing quality of Lupin’s LAI product.
Advertisement
This milestone aligns with global regulatory trends encouraging the development of complex generics that expand access while lowering healthcare costs. By securing this approval, Lupin demonstrates its ability to navigate regulatory complexities and deliver advanced therapies to patients more quickly.
Business Significance
From a commercial perspective, this approval is a strategic win in the high-value U.S. market. Risperidone LAI’s reference drug, Risperdal Consta®, recorded annual sales of approximately USD 190 million in the U.S. (IQVIA MAT July 2025). With 180-day CGT exclusivity, Lupin is positioned to capture significant market share and drive near-term revenue growth.
This development also strengthens Lupin’s reputation as a global leader in complex generics and specialty medicines. By launching the first product from Nanomi’s LAI platform, Lupin signals its long-term ambition to diversify its portfolio into higher-margin specialty products and reduce reliance on commoditized generics.
Patients’ Significance
For patients with schizophrenia and bipolar I disorder, the approval offers access to a new long-acting injectable therapy with proven efficacy and improved convenience. The uniform release mechanism reduces fluctuations in drug levels, potentially improving treatment adherence and stability in chronic psychiatric conditions.
Patients may also benefit from more comfortable administration, reduced dosing frequency, and greater treatment flexibility. With better adherence and outcomes, this approval represents a meaningful advancement in patient-centered care for mental health disorders, where relapse prevention is a key challenge.
Policy Significance
At the policy level, the FDA approval supports broader goals of expanding access to complex generics and addressing mental health needs. The CGT program incentivizes development of generics with limited competition, ensuring patients and payers gain access to affordable, high-quality treatments.
Mental health remains a public health priority in the U.S., with schizophrenia and bipolar disorder contributing significantly to disability and healthcare costs. Affordable LAIs can reduce hospitalizations, lower long-term care expenses, and align with health system strategies promoting value-based care and preventive interventions.
Transaction Highlights
The U.S. FDA approval covers Risperidone extended-release injectable suspension in 25 mg, 37.5 mg, and 50 mg single-dose vials, making it bioequivalent to the reference drug Risperdal Consta®, which generated approximately USD 190 million in annual U.S. sales (IQVIA MAT July 2025). Importantly, the approval grants 180-day CGT exclusivity, giving Lupin a competitive head start in the U.S. market. This milestone also represents the first FDA-approved product leveraging Nanomi’s proprietary long-acting injectable platform, underscoring Lupin’s ability to bring complex injectables to patients.
With this regulatory success, Lupin has firmly established its Nanomi LAI technology on the global stage, blending scientific innovation, commercial opportunity, and patient impact into a single breakthrough moment. As the company continues to advance novel long acting injectables, this approval marks the beginning of a new growth chapter in Lupin’s evolution from a generic’s leader into a specialty and complex injectables powerhouse.
Source: Lupin limited Press Release
