The FDA Has Approved the First Generic Albuterol Inhaler for Asthma

As people with asthma know all too well, the cost of breathing more easily can be pretty steep—one “rescue” inhaler can cost $70 or more. Hopefully, those prices will finally drop with the introduction of the first generic version, which the FDA approved earlier this week for those 4 years of age or older.

The brand-name version currently available is the ProAir HFA Inhalation Aerosol, an albuterol sulfate inhaler that treats or prevents bronchospasms. When these spasms occur, muscles around the airways are swelling, tightening, and constricting air flow; this makes it difficult for people with asthma to breathe. Spasms sometimes happen during or after exercise, or at the beginning and end of the day. Some people rely on the inhaler to keep their airways open during allergy season or when they’re sick, while others use it on a daily basis.

The reason it’s taken so long for a generic version to be approved isn’t because of patent restrictions. Instead, it’s because the inhaler itself is difficult to develop. If you’ve ever used a rescue inhaler, you’ve probably seen the little ticker on the back that keeps track of how many doses are left: Each time you take a puff, the inhaler dispenses a certain amount of medicine and then updates the countdown. As the FDA explained in a press release, it’s not an easy process to perfect.

“Metered dose inhalers like these are known as complex generics, which are traditionally harder to copy because of their complex formulation or mode of delivery,” FDA commissioner Dr. Stephen M. Hahn said in the release. “As a result, too many complex drugs lack generic competition even after patents and exclusivities no longer block generic approval.”

WCNC reports that the new inhaler will be manufactured by Perrigo Company plc and its partner Catalent Pharma Solutions, though we don’t know when exactly it will hit the market or how much cheaper it will be than its brand-name competition.

There still isn’t a cure for asthma, but making treatments more affordable is an important way to prevent it from becoming a life-threatening condition.