Since discontinuing its two branded versions of asthma inhaler Flovent at the start of 2024, GSK has still produced “authorized generic” versions of the treatment, which are the same products with different labels distributed by another firm.
Now, true competition has finally arrived for GSK’s Flovent in the form of an FDA approval for Glenmark’s fluticasone propionate inhalation aerosol. The inhaled corticosteroid, which reduces inflammation in the lungs, is a maintenance treatment and can be used by patients ages 4 and older to prevent wheezing and shortness of breath.
As the first company to gain FDA approval for a Flovent generic, Glenmark receives 180 days of exclusivity before other makers of generics can enter the market. Glenmark will begin distributing fluticasone this month, the company said in a release.
In a social media post, rxradio.fm hailed the approval as the “first true generic” of the treatment, “potentially reshaping access and pricing for millions of asthma patients.”
In May of 2022, GSK’s Ohio-based partner Prasco Laboratories began selling Flovent authorized generics. The association of the companies dates back at least to 2009, when Prasco signed on to market and distribute GSK’s Flonase nasal spray under a similar arrangement.
Privately held Prasco specializes in bringing branded products to the market as authorized generics, touting itself as the “acknowledged category leader.”
“Today's approval of the first generic fluticasone propionate inhalation aerosol represents an important step in expanding access to affordable asthma treatment,” Iilun Murphy, M.D., the director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research, said in a release.
In its annual report, GSK reported combined 2025 sales (PDF) of its products in its Flovent/Flixotide franchise at 421 million pounds sterling ($555 million), with U.S. sales at 277 million pounds ($366 million). The report lists Flovent’s patent protection ending this year.