US FDA introduces patent submission date updates to Orange Book

The FDA is publishing this data to improve transparency and provide additional information to regulated industry and the public

The US 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 will show patent submission dates where available.

The FDA is publishing this data to improve transparency and provide additional information to regulated industry and the public. The information may help generic drug manufacturers determine the earliest date when they may be able to market new generic medicines. Increased competition in the market can help lower drug prices, and earlier availability may help prices decrease more quickly.