Patents And Regulatory Exclusivities On Inhalers For Asthma And COPD, 1986-2020.

ABSTRACT: Inhalers are the mainstay of treatment for asthma and chronic obstructive pulmonary disease (COPD). These products face limited generic competition in the US and remain expensive. To better understand the strategies that brand-name inhaler manufacturers have employed to preserve their market dominance, we analyzed all patents and regulatory exclusivities granted to inhalers approved by the Food and Drug Administration between 1986 and 2020. Of the sixty-two inhalers approved, fifty-three were brand-name products, and these brand-name products had a median of sixteen years of protection from generic competition. Only one inhaler contained an ingredient with a new mechanism of action. More than half of all patents were on the inhaler devices, not the active ingredients or other aspects of th

SUBMITTER: Feldman WB 

PROVIDER: S-EPMC10328096 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature