Lupin receives approval from the US FDA for its Selexipag for injection

In 2022, sales of the Selexipag Franchise in the US stood at $ 1.1 billion. The sales for January 1 to September 30, 2023, stood at $978 million

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Global pharmaceutical major Lupin Limited (Lupin) has received tentative approval for its Abbreviated New Drug Application for Selexipag for Injection, 1800 mcg/vial, Single-dose Vial. The company now also has the approval to market a generic equivalent of Uptravi for Injection, 1800 mcg/vial, of Actelion Pharmaceuticals. Lupin will manufacture this new product at its Nagpur facility in India, the company informed in a regulatory filing.

The sales of the Selexipag Franchise in the US stood at $ 1.1 billion for 2022. The sales for January 1 to September 30, 2023, stood at $978 million, the company said in the filing.

Earlier in October, Lupin Limited (Lupin) had received tentative approval from the United States Food and Drug Administration (US FDA) for its abbreviated new drug application for apalutamide tablets, 60 mg, to market a generic equivalent of erleada tablets, 60 mg of Janssen Biotech, Inc.

The product will be manufactured at Lupin’s Pithampur facility in India. Apalutamide tablets, 60 mg had estimated sales of $1,185.5 million annually in the US.

Lupin is likely to announce its Q2FY24 result on November 8. In the first quarter of the current financial year, Lupin reported consolidated profit after tax of Rs 453 crore on the back of healthy operational performance. Sequentially, the net profit nearly doubled from Rs 242.4 crore in Q4FY23.