Cipla Granted Approval For First US Proventil Rival
Indian Firm Says Albuterol Shipments Will Be ‘Staggered’
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.
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Sandoz has struck a US deal to in-license both branded Proventil HFA and an authorized generic version of the albuterol sulfate product from Kindeva Drug Delivery. The deal comes after a busy year for generic versions of albuterol that have transformed the market dynamics for the respiratory treatment.
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.
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.