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FTC Issues Orange Book Warnings on Over 100 Drug Patents

Washington, D.C. – Today, the U.S. Federal Trade Commission (FTC) challenged more than 100 patents held by manufacturers, including brand-name asthma inhalers, epinephrine autoinjectors, and other drug products, as improperly or inaccurately listed in the Food and Drug Administration’s “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the Orange Book. The FTC noted that improper listings “may delay lower-cost generic drug competition, stall drug development, and stifle innovation.” In September, the FTC issued a policy statement warning that it intended to scrutinize improper listings in the Orange Book to determine whether they constitute “unfair methods of competition” in violation of Section 5 of the Federal Trade Commission Act.

In response, Peter Maybarduk, director of the Access to Medicines program at Public Citizen, issued the following statement:

“There are many ways Big Pharma games the patent system to extend market exclusivities and maximize profits at the expense of Americans. We applaud the FTC for taking this step to address one of the avenues for abuse of the system to keep prices high.”