FDA has updated the Orange Book with patent submission dates

The US Food and Drug Administration (FDA) has updated the Approved Drug Products with Therapeutic Equivalence Evaluations, known as the “Orange Book”, by adding patent submission dates. The FDA has published this data with the aim of increasing transparency and generic drug competition. The addition of patent submission dates may help generic drug manufacturers determine the earliest date when they may be able to market new generic medicines.

Since 2013, when the FDA began collecting the patent submission date data, the agency states there are about 4,000 patent records for which submission dates are available.

The FDA says the Orange Book will now publish patent submission dates for all new records going forward as a result of a final rule from October 2016, known as “Abbreviated New Drug Applications and 505(b)(2) Applications”.

A New Drug Application (NDA) holder can email error correction requests, including justifications for the requests, to orangebook@fda.hhs.gov. The FDA has said that “requests will be considered on a case by case basis and, if accurate, will be updated in the Orange Book as soon as is practicable”.

To read more about the patent submission date updates to the Orange Book, please click here.