Lupin Gains After USFDA Nod For Risperidone Injectable To Treat Schizophrenia And Bipolar I Disorder

Lupin's shares rose 2.8% in afternoon trading after the company received a key U.S. Food and Drug Administration (FDA) approval.

On Wednesday, Lupin received USFDA approval for its Abbreviated New Drug Application (ANDA) for Risperidone extended-release injectable suspension in 25 mg, 37.5 mg, and 50 mg single-dose vials. It is used to treat schizophrenia and bipolar I disorder.

The approval comes with a 180-day competitive generic therapies (CGT) exclusivity and marks Lupin's first product developed using its unit Nanomi's proprietary technology. Nanomi specializes in innovative long-acting injectable (LAI) medicines aimed at improving patient outcomes.

The approved Risperidone suspension is bioequivalent to Janssen's Risperdal Consta and is indicated for treating schizophrenia, as well as for maintenance therapy in bipolar I disorder, either alone or with lithium/valproate.

According to IQVIA's Moving Annual Total data for the 12-month period ending July 2025 (MAT July 2025), Risperidone LAI had estimated U.S. annual sales of $190 million, highlighting a significant market opportunity for Lupin.

MAT is a standard to track performance in the pharmaceutical industry.

“We are very pleased with the approval of the first product from our Nanomi LAI platform. This first-cycle approval is a testament to the capabilities we have established for complex injectables across our teams in R & D, Operations and related functions,” said Vinita Gupta, CEO of Lupin.

“It validates our platform capabilities at Nanomi and underscores our commitment to expanding access to complex injectables for patients globally. As we execute on our strategy to evolve specialty/novel products, we plan to leverage the Nanomi platform for novel long-acting injectables that meet unmet patient needs.”

Q1 Outperformance

Lupin's net profit rose 52.1% to ₹1,219 crore, beating street estimates. Revenue came in at ₹6,268 crore, up 11.9%. EBITDA jumped 39.2% to ₹1,727 crore, driving margins to 27.6% from 22.2% a year ago.

Stock Watch

The US FDA approval immediately drew retail attention to the stock. Lupin is currently the third-highest trending stock on Stocktwits. Sentiment remains 'neutral'.

Year-to-date, the stock has lost over 17% in total value.

For updates and corrections, email newsroom[at]stocktwits[dot]com

MENAFN03092025007385015968ID1110011085