orange book

Orange Book. Patents. A list of patents on drugs or drug products for which generic-drug applications may be submitted to the Food and Drug Administration. • The expiration dates of the patents are also listed. An applicant may submit a generic-drug application at any time, but the applicant must either accept deferral of FDA approval until the patent expires or contest the patent’s validity. The Orange Book’s official title is Approved Drug Products with Therapeutic Equivalence Evaluations.

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词条贡献者

译者Natalie，在一家西班牙律师事务所的北京办公室担任全职法律翻译，擅长翻译涉及医疗健康领域的法律文件。