Since discontinuing two branded versions of its asthma inhaler Flovent in early 2024, GSK is still producing a “certified generic” version of the treatment, which is the same product with a different label sold by another company.
Now, real competition has finally arrived for GSK’s Flovent in the form of FDA approval of Glenmark’s fluticasone propionate inhalation aerosol. Inhaled corticosteroids, which reduce inflammation in the lungs, are maintenance therapy and can be used in patients 4 years and older to prevent wheezing and shortness of breath.
As the first company to receive FDA approval for the Flovent generic drug, Glenmark receives 180 days of exclusivity before any other generic drug manufacturer enters the market. Glenmark will begin distributing fluticasone this month, the company said in a release.
In a social media post, rxradio.fm praised the approval, saying it was the “first true generic version” of the treatment and “has the potential to transform access and affordability for millions of asthma patients.”
Since early 2024, GSK’s Ohio-based partner Plasco Laboratories has been marketing a certified generic version of Flovent. The partnership between the two companies dates back to at least 2009, when Prasco signed a deal to market and distribute GSK’s Flonase nasal spray under a similar arrangement.
Privately held Prasco specializes in bringing branded products to market as certified generic drugs and bills itself as a “recognized category leader.”
“Today’s approval of the first generic version of fluticasone propionate inhaled aerosol is an important step in expanding access to affordable asthma treatment,” Irun Murphy, M.D., 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 2025 combined sales (PDF) of products from its Flovent/Flixotide franchise of £421 million ($555 million), with US sales of £277 million ($366 million). The report states that Flovent’s patent protection will end this year.
