The U.S. Food and Drug Administration (FDA) today 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. The FDA is publishing this data to improve transparency and provide additional information to regulated industry and the public. This 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.
The availability of patent submission dates also fulfills a commitment the FDA made in the October 2016 final rule “Abbreviated New Drug Applications and 505(b)(2) Applications.”
Please note that the 37th edition Orange Book Preface is now available on the web or as a downloadable PDF (8.4MB).