Investors in pharma giant Lupin Ltd are waiting for more details on the launch of much-awaited inhaler drug Spiriva generic. The company's board of Directors shall meet on May 9 to declare the audited financial results of the company for Q4 FY23 and recommend dividend.

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During the last earnings call when Lupin had announced its third quarter numbers, the company said that it expects to launch Spiriva generic in the first half of 2023.

In the earnings call on February 10, Lupin’s executive director, global CFO, and head of corporate affairs Ramesh Swaminathan said, “Spiriva, in our opinion, should certainly come through with great deal of confidence we're saying this, in the first half of the current year itself.”

Also read: Lupin expects approval for Spiriva generic by the end of this fiscal

The Spiriva drug, which is an inhaler, is expected to be one of the biggest opportunities for Lupin. It is a prescription drug that is used long term to improve breathing in people with certain respiratory conditions. The drug can significantly aid the company’s financial performance as it has limited competition in the United States and is a high-margin product.

The Spiriva generic market size is estimated to be $700 million and Lupin is expected to be the only generic company presently to launch this product. As the competition is limited for at least the next 2-3 years, Lupin is estimated to make around $150 million, factoring in a 30 percent discount and 30 percent market share.

However, regulatory snags have kept the launch of the drug on hold. Lupin had received a priority review from the US Food and Drug Administration (USFDA) for the Spiriva generic last year. The company informed in February that the US drug regulator has now set a Target Action Date (TAD) of April 2023 without inspection and of July 2023 with inspection.

TAD is essentially an aspirational deadline set by USFDA for action on a drug application.

“On Spiriva, we continue to make progress and have received priority review from the FDA for a target action date in April, without inspection, or July, with inspection. In the meantime, we are getting ready with launch preparedness,” Swaminathan had said in the February earnings call.

On Thursday, Lupin shares were trading at Rs 692, down 2.2 percent, at 3pm.

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