Inhalers have long been the primary treatment for asthma and chronic obstructive pulmonary disease. Although these products have been on the market for decades, they remain expensive — today representing approximately 5 percent of total net retail spending on prescription drugs. The main driver of high prices is limited generic competition. A new study, released before its print Health Activity, analyzed all inhaler products approved by the Food and Drug Administration (FDA) between 1986 and 2020 to better understand how brand-name manufacturers preserved their market dominance and limited generic competition through the patent and regulatory system. According to the authors, 85 percent of the approved products are brand-name products, with a median of sixteen years of protection from generic competition. Another important finding of the study is that manufacturers are constantly moving components from one transmission device to another, obtaining new patents and thus extending their exclusivity in the market. . Among the products where such “device hops” occur, the median time from approval of an origin product to the last-expiring patent of follow-ons is about twenty-eight years. To complete their study, the authors created a database of all patents and exclusivities of the FDA-approved inhaler listed on the FDA’s annual A.Validated Drug Products with Therapeutic Equivalence Assessments (also known as Orange Book) and used LexisNexis TotalPatent One to obtain more information about these Orange Book patents.
Patents and Regulatory Exclusive Inhalers for Asthma And COPD, 1986–2020
By William B. Feldman, Doni Bloomfield, Reed F. Beall, and Aaron S. Kesselheim
Feldman and Kesselheim with Brigham and Women’s Hospital; Bloomfield is with the U.S. Court of Appeals for the DC Circuit; and Beall with the University of Calgary.
This study, supported by the National Institutes of Health and The Commonwealth Fund, will also appear in the June 2022 issue of the journal.
“Patents and regulatory exclusives have been key factors in delaying generic inhaler competition,” the authors conclude. “Our findings highlight how the current U.S. regulatory system rewards incremental changes to older products … Regulatory and patent reform are essential to ensure that rewards are provided. of brand-name inhaler manufacturers that are increasingly demonstrating the increased clinical benefit of the new products. “
Two related articles were simultaneously released by Health Affairs: