Sandoz has in-licensed commercial distribution rights to brand and authorized generic Proventil HFA from Kindeva Drug Delivery. The deal positions Novartis’ Sandoz to compete for the U.S. market for albuterol medicines used in the treatment of wheezing and shortness of breath.
3M Drug Delivery Systems, which rebranded as Kindeva last year, has a long history with the inhaled albuterol formulation Proventil. Regulatory paperwork on Merck’s Proventil lists 3M as the developer and manufacturer of the innovator product. Then, in 2019, 3M said it was producing an authorized generic version of Proventil for Endo’s Par Pharmaceutical.
Kindeva has now granted commercial distribution rights to brand and authorized generic Proventil to Sandoz. Having secured the rights, Sandoz immediately made the authorized generic available in the U.S.
Sandoz said its involvement in the market will help ensure a reliable supply of albuterol medicines, thereby offsetting pressures the sector has faced during the COVID-19 pandemic.
“There has been a surge in demand for albuterol medicines over the past year. Hospitals increasingly switched to using metered-dose albuterol inhalers rather than nebulizers to treat the growing number of COVID-19 patients. Pharmacies also saw increased demand for albuterol inhalers after the CDC recommended that Americans stock up on necessary medications,” Sandoz said in a statement.
Sandoz framed the deal as part of its focus on growing its portfolio of respiratory drugs. The generic drugmaker already provides products such as AirFluSal Forspiro, a salmeterol-fluticasone propionate formulation for the treatment of severe asthma and chronic obstructive pulmonary disease. In the generic Proventil, Sandoz has a bronchodilator to address symptoms experienced by those patients.
Multiple other companies compete for the same market with products such as ProAir and its generic copies. Last year, Lupin CEO Vinita Gupta told investors ProAir is the largest part of the market but, at that time, Proventil had “taken a little more of the market, really at the cost of GSK.”