By Ratib Ali and Celia Lu ( November 15, 2024, 5:49 PM EST) -- The U.S. Food and Drug Administration's Orange Book lists all nonbiologic drugs approved by the FDA to be marketed in the U.S. Drug manufacturers, when seeking FDA approval for a new drug, must list any patent that either (1) "claims the drug" and "is a drug substance (active ingredient) patent or a drug product (formulation or composition) patent," or (2) "claims a method of using such drug for which approval is sought."...
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