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Frequently Asked Questions

Where 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 is the Orange Book?

On November 21, 2017, the U.S. Food and Drug Administration (FDA) introduced an important data update to Approved Drug Products with Therapeutic Equivalence Evaluations – known as the “Orange Book.” Search results and drug listings now show patent submission dates where available.

Why did FDA remove biologics from the Orange Book?

On March 23, 2020, FDA removed from the Orange Book the listings for "biological products" that have been approved in applications under section 505 of the FD&C Act because these products are no longer "listed drugs" (see section 7002 (e) (4) of the Biologics Price Competition and Innovation Act of 2009).

Why is the FDA publishing patent submission dates?

The FDA is publishing patent submission dates to fulfill a commitment in the October 2016 final rule “ Abbreviated New Drug Applications and 505 (b) (2) Applications ,” which implemented portions of Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA).


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