Pricy inhalers remain expensive due to device tweaks that keep competitors at bay, researchers find
New research published in Health Affairs today highlights the way in which the FDA’s inhaler regulations have rewarded incremental adjustments to older products, thereby enabling companies to skirt around cheaper competition.
A DC appeals court clerk and researchers from Harvard and the University of Calgary dug through all the patents and regulatory exclusivities granted to inhalers approved by the FDA between 1986 and 2020, finding that of the 62 inhalers approved, 53 (or 85%) were brand-name products, with a median of 16 years of protection from 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 the Boston-based Brigham and Women’s Hospital, explained to Endpoints News that there are several reasons why generic competition for inhalers is so sparse.
“Brand-name manufacturers have secured long periods of market exclusivity by patenting the delivery devices of their products – even when the active ingredients are off-patent – and by moving active ingredients from one device to the next (which we refer to as ‘device hopping’),” he said.
For instance, the researchers pointed out GSK received 35 years of protection from competition after FDA approval on its fluticasone inhalers through the successive release of new inhaler devices containing fluticasone: Flovent (approved in 1996), Flovent Rotadisk (1997), Flovent Diskus (2000), Flovent HFA (2004), and most recently Arnuity Ellipta (2014).
The release of these new inhaler versions means that any generic versions linked to older products are no longer interchangeable and cannot automatically be substituted at the pharmacy for that new product, they explained.
While patents are generally the culprit to 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 approving interchangeable generic inhalers.”
So what can be done to help bring down the cost of inhalers?
“We offer a number of solutions aimed at targeting these lifecycle management practices, including Orange Book reform (e.g., preventing brand-name manufacturers from listing device patents in the Orange Book and/or preventing manufacturers from adding patents to the Orange Book after approval unless associated with meaningful 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.