FTC challenges over 100 patents as improperly listed in the FDA's Orange Book

The US Federal Trade Commission (FTC) has challenged more than 100 patents held by manufacturers of brand-name asthma inhalers, epinephrine autoinjectors, and other drug products as improperly or inaccurately listed in the Food and Drug Administration’s (FDA) publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the “Orange Book.”

Improper listings may delay lower-cost generic drug competition, stall drug development, and stifle innovation, the agency said.

The Commission has also notified the FDA that it disputes the accuracy or relevance of the listed information for these patents, which may require that the manufacturers remove the listing or certify under penalty of perjury that the listings comply with applicable statutory and regulatory requirements.