New research published in Health Affairs today highlights how FDA regulations on inhalers have rewarded incremental adjustments to older products, allowing companies to bypass cheaper competition.
A DC Court of Appeals clerk and researchers from Harvard and the University of Calgary searched all patents and regulatory exclusivities granted to FDA-approved inhalers between 1986 and 2020, finding that of the 62 approved inhalers, 53 (or 85%) were brand-name products, with a median of 16 years of protection against generic competition.
“The only inhaler to enter the US market during the study period with a new mechanism of action was the muscarinic antagonist Atrovent (ipratropium) in 1986,” they wrote.
First author William Feldman, associate physician in the division of pulmonary and critical care medicine at Brigham and Women’s Hospital in Boston, told Terminal news that there are several reasons why generic competition for inhalers is so rare.
“Branded manufacturers have achieved long periods of market exclusivity by patenting the delivery devices of their products – even when the active ingredients are no longer patented – and by moving the active ingredients from one device to another ( which we call ‘jumping device’),” he said.
For example, the researchers pointed out that GSK received 35 years of protection from competition after the FDA approval of its fluticasone inhalers thanks to the successive release of new inhalers containing fluticasone: Flovent (approved in 1996), Flovent Rotadisk (1997), Flovent Diskus (2000), Flovent HFA (2004), and more recently Arnuity Ellipta (2014).
The release of these new versions of inhalers means that all generic versions linked to older products are no longer interchangeable and cannot be automatically replaced in pharmacies with this new product, they explained.
While patents are generally responsible for limiting competition, Feldman also noted the higher cost of developing complex generics like inhalers and the fact that the FDA “sets a high standard for approval of interchangeable generic inhalers.” .
So what can be done to help reduce the cost of inhalers?
“We offer a number of solutions aimed at targeting these lifecycle management practices, including Orange Book reform (e.g. preventing branded manufacturers from listing device patents in the Orange Book and/or or prevent manufacturers from adding patents to the orange book after approval unless associated with significant clinical benefit) and reform at the USPTO (e.g., having a special art unit at the USPTO focused on pharmaceuticals to ensure the quality of issued patents),” Feldman said.