Abstract: Objective To provide reference for China's establishment of a drug patent information retrieval system and for the improvement of the drug patent linkage system in China through research on the patent information in the American Orange Book. Methods The patent information included in the American Orange Book and the management mechanisms for the submission, modification, and deletion of patent information were analyzed. Results Pharmaceutical patent information was an important part of drug regulatory information. Improving the authenticity and accuracy of patent registration information was a long-term undertaking that requires continuous optimization. Conclusion It is recommended that the collection and release of drug patent information continue to be improved in line with the actual situation in China, and that pharmaceutical companies compete on an equal footing so as to leave pharmaceutical companies more motivated for and confident about drug R&D and innovation.

Key words: drug registration, Orange Book, patent information, patent linkage