Lupin Gets Long-Pending U.S. FDA Approval For Key Generic Asthma Drug

Lupin Ltd. has received the U.S. drug regulator’s approval to make the generic of a key asthma therapy at a time the threat of the new pneumonia-causing coronavirus looms over the world.

The U. S. Food and Drug Administration gave its approval to the Mumbai-based drugmaker’s Albuterol Sulfate Inhalation Aerosol, 90 mcg, according to an exchange filing on Tuesday. The copycat version of Teva Pharmaceutical Industries Ltd.’s ProAir—for which the approval was pending for at least two years—will be used to treat acute bronchospasm or prevent asthmatic symptoms, and will be manufactured at Lupin’s Indore (unit III) facility in India, it said.

This approval marks a significant milestone in the company’s complex generics evolution, Vinita Gupta, chief executive officer at Lupin, said in the filing. “The approval is timely as Albuterol MDI is a key rescue inhalation product for asthma patients who are at an increased risk of covid-related complications,” she said. “We look forward to launching the product this quarter and expect a steady ramp up through the fiscal.”

The novel virus, which has so far infected 23.5 million people worldwide and caused more than 810,000 deaths, has a wide range of symptoms, including fever, coughing and breathing difficulties.

Nitin Agarwal, research analyst at IDFC securities, said it’s an important development for the company. ProAir is a pretty complex product having a large market, so it’s going to be a valuable product for the company, he told BloombergQuint.

The total Albuterol Sulfate Inhalation Aerosol market had U.S. sales of about $2.9 billion, of which the ProAir market accounted for $1.3 billion, according to market researcher IQVIA’s June 2020 data. That’s nearly 45% of the U.S. Albuterol Sulfate Inhalation Aerosol market.

“ProAir approval was long awaited. The company is working on a pipeline of device based generic inhalation assets and this marks their first approval in the category,” Vishal Manchanda, research analyst at Nirmal Bang Securities, told BloombergQuint. “This can be a $50-100 million of sales opportunity for the company. With around 15% share, it can convert to $75 million worth of annualised sales.”

Shares of Lupin opened 3% higher on Tuesday but soon pared the gains to trade 1% higher. That compares with the Nifty 50 Index’s 0.11% rise. Of the 45 analysts tracking the stock, 18 have a ‘buy’ rating, 13 recommend a ‘hold’ and the rest suggests a ‘sell’. The average of Bloomberg consensus 12-month target prices implies a downside of 10.8%.