NEW DELHI: Lupin Ltd on Tuesday said it has received the US Food and Drug Administration’s approval for the generic of blockbuster drug ProAir, which is used for the treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms.
“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. We look forward to launching the product this quarter and expect a steady rampup through the fiscal year," Lupin chief executive officer Vinita Gupta said in a statement.
Lupin will manufacture the drug at its Unit III at Indore in Madhya Pradesh.
A blockbuster drug is one which has annual sales of over $1 bilion dollar. For the 12 months ende June, albuterol sulfate inhalation aerosol, which is the common name of the drug, had sales of approximately $2.9 billion in the US, Lupin said in a release quoting data from market research firm IQVIA.
The total sales of albuterol sulfate inhalation aerosol included $1.3 billion generated by the innovator, Teva Branded Pharmaceutical Products R&D Inc, from sales of ProAir as well as other generic versions. Apart from inhalation aerosol, albuterol sulfate is also produced by companies in oral tablet form.
According to information on the US FDA website, other manufacturers of albuterol sulfate inhalation aerosol include Sun Pharmaceutical Industries, Watson Laboratories, Aurobindo Pharma and Cipla.
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