Brand name inhalers are very good at blocking competition, better even than nebulizers, study finds

09 Sep 2022
endpts.com
While just three brand-name inhalers approved between 1986 and 2020 now face generic competition (thanks in a large part to patent thickets and companies shifting old active ingredients to new devices), the same sort of long monopoly extensions are not as prevalent for nebulizers, a new study published today in Nature Biotechnology explains. The Harvard and University of Calgary authors note that nearly one-third of brand-name nebulizer solutions, which include drugs for asthma or other conditions in an aerosol mist form, faced generic competition before expiration of FDA-listed patents, compared to just 2% of brand-name inhalers. What’s more is that when considering actual market exclusivity (i.e., “the time from brand-name drug approval to generic competition, brand-name drug discontinuation, or 31 December 2020, whichever occurred first”), 13 brand-name solutions for nebulization had a median of just 5.2 years (IQR: 3.5–10.4 years) without generic competition. In contrast, inhalers saw 17.4 years of median protection when counting hops to new devices as a single product line (IQR: 13.2–23.2 years). Brand-name inhalers making such shifts to new devices, they wrote, as to a means to obtaining a longer period of exclusivity include Merck’s Proventil and Foradil, GSK’s Ventolin, Boehringer Ingelheim’s Combivent and Atrovent, and AstraZeneca’s Pulmicort. So why the wide discrepancy between inhalers and nebulizers? First author William Feldman of Harvard Medical School told Endpoints News via email: But nebulizers also saw shorter periods of market exclusivity because of delays in the release of brand-name nebulizer solutions, Feldman , Doni Bloomfield, Reed Beall  and Aaron Kesselheim wrote. “The time between the release of inhalers and the release of the same ingredients in nebulized form has meant that certain at-risk patients lacked access to preferred forms of treatment,” they wrote. “Physicians frequently rely on nebulizers to treat asthma and COPD, because some patients may not be able to use inhalers and because some simply favor nebulizers. A recent study of Black and Latino/Latina patients with moderate-to-severe asthma, for example, found that 67% chose to use nebulizers for SABA administration.” Another concerning finding cited by the authors is a recent turn by brand name manufacturers to enantiomers of older racemic formulations — levalbuterol (an enantiomer of racemic albuterol) and arformoterol (an enantiomer of racemic formoterol) — “despite little, if any, clinical benefit associated with the newer products compared to the older ones,” they added. So how to fix this situation? The authors point to regulatory reforms, saying it’s:
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