The U.S. Federal Trade Commission (FTC) is challenging more than 100 patents related to asthma inhalers and other drug products due to concerns they are preventing “lower-cost generic alternatives” from competing in the marketplace, harming consumer choices.
The patents are listed in the U.S. Food and Drug Administration’s (FDA) “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the “Orange Book,” according to a Nov. 7 press release by the FTC. “The Orange Book is a list of drug products approved by the FDA as safe and effective. When a brand pharmaceutical company lists a patent in the Orange Book, it may lead to a statutory stay that generally blocks the introduction of competing drug products for 30 months, including lower-cost generic alternatives.”