Tracking R&D behavior: Bibliometric analysis of drug patents in the Orange Book

The Publication Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) identifies drug products approved by the United States Food and Drug Administration (USFDA) for safety and effectiveness, and provides substantial information on new drug applications (NDAs) with patent data. To explore the patterns among drug patents in the Orange Book, this study used patent bibliometric analysis. The productivity and impact are presented at the assignee level and applicant level, respectively, and the applicant's patent portfolio is further discussed. 2,033 drug patents are identified in this current study. Our findings indicate that the applicant's patent portfolio in the Orange Book is helpful in revealing the technological capability and patent strategy of the pharmaceutical incumbents. By linking drug data and patent information, this current study sheds light on patent research in the pharmaceutical industry.