The FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book, is its catalog of all approved chemical products. The two agencies said Sept. 14 that pharmaceutical companies can face legal consequences if they include improper patents in the Orange Book.
“Improperly listing patents in the Orange Book may harm competition from less expensive generic alternatives and keep prices artificially high,” the FTC said in a news release. “The FTC will scrutinize improper Orange Book patent listings as potential unfair methods of competition in violation of Section 5 of the FTC Act.”
