Revisiting FDA’s Original Guidance on Orange Book Listability in Light of Heightened FTC Scrutiny

The listing of many types of patents in the FDA’s Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) is fairly straightforward. Patents covering the approved drug product (active pharmaceutical ingredient) or its methods of use can be listed. However, other kinds of patents may require a more careful evaluation, especially in light of a recent policy statement issued by the FTC signaling plans “to scrutinize improper Orange Book listings to determine whether these...
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