Drug Manufacturers Gain More Control Over Market Exclusivity for Generics

A recent court decision strengthened the trend that a drug manufacturer can freely delist patents from the Orange Book so long as no Abbreviated New Drug Application (ANDA) containing a paragraph IV certification has been filed. Whether a patent is listed or delisted is up to the drug manufacturer; the Food and Drug Administration (FDA) continues to play only a ministerial role in the listing and delisting of patents.

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