US Albuterol Market Hots Up With Lupin ProAir Approval
Analyst Predicts Albuterol ‘End Of The Road’
The market for generic albuterol sulfate is becoming increasingly commoditized in the US, with Lupin announcing FDA approval for generic ProAir – the Indian company’s first device-based inhalation product in the US. Nevertheless, it remains a lucrative opportunity for ANDA sponsors.
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Having gained from Perrigo’s US withdrawal of generic ProAir (albuterol sulphate), Lupin plans to ramp up capacity by its financial fourth quarter as demand is seen rising on account of flu and COVID-19 cases in the US. Meanwhile, FDA observations at its Somerset facility provide a dampener.
After a high-profile launch early this year, first-mover Perrigo has recalled its albuterol sulfate aerosol in the US following complaints of inhalers failing to dispense due to “clogging.” The firm has revealed the expected financial impact of the move as well as commenting on how long it expects the product to be off the market, during which albuterol rivals Cipla and Lupin could benefit.
Shortly after wrapping up a Phase III trial for its proposed generic Advair Diskus product in the US, Cipla has won FDA approval for the first generic Proventil HFA product, as it continues to build up steam in the US respiratory market.