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Frequently Asked Questions

What are Orange Book listed patents?

Orange Book Listed Patents. This means that the patent must cover the actual drug compound, formulations of the drug, or the method of treating a certain disease by administering the drug. However, process patents, which identify the method for making the drug compound, are not permitted.

What is the Orange Book and why is it important?

The Orange Book makes it easier for drug makers to monitor for new generic drugs that come on the market and infringe on their own patents. Therefore, such businesses holding patents on FDA-approved drugs will very easily know if new generic versions are being manufactured and sold.

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).

How often are the Orange Book downloadable data files updated?

The Orange Book downloadable data files are updated monthly. We make every effort to prevent errors and discrepancies in the Approved Drug Products data files; however, if you wish to report an error or discrepancy in drug data, please send a brief description of the problem to [email protected]

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