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However, not all FDA-approved patented drugs are listed in the Orange Book, and that could be for two reasons: The patent is a process patent and not a patent on the actual medication. The patent holder failed to ask the FDA to include it in the Orange Book.Are FDA actions in the Orange Book official FDA actions?
9 TE evaluations in the Orange Book are not official FDA actions affecting the legal status of products under the FD&C Act. See, e.g., 45 FR 72582 at 72597 (October 31, 1980). Drug products with approved applications that are single-source (i.e., there is only one approved product available for that active ingredient, dosage form, route ofWhere is the patent submission date in the Orange Book?
If patent submission date information is available, it will appear in the far right column on the Patent and Exclusivity page for that product. Why doesn’t the Orange Book include patent submission dates for most records? The FDA began patent submission date data collection in 2013.What happens if a generic drug is found in the Orange Book?
If a drug maker finds the new generic version in the Orange Book, it can notify the new creator of possible infringement and can subsequently file a patent infringement suit (without having to see the generic drug that was created).