This study was completed by the USPTO in conjunction with the Federal Drug Administration (FDA) in response to a request from Congress. It provides a baseline approach that researchers and policy makers can use in future analysis for examining the number of years from the time a New Drug Application (NDA) is first approved until the first launch of a generic. Using publicly available United States Patent and Trademark Office (USPTO) and Food and Drug Administration (FDA) data, the report applies this approach to case studies of 25 NDAs.
For each NDA associated with specific drug products, this study maps the scope and duration of patent protections listed in the FDA's publication “Approved Drug Products with Therapeutic Equivalence Evaluations” (commonly known as the Orange Book) and exclusivities under the Federal Food, Drug and Cosmetic Act during a specific period of time. The study also identifies the launch date, if any, of the first generic version of the drug product that had occurred as of September 18, 2023.
In some of the drug products studied, a generic launch occurred before all of the Orange Book-listed patents associated with that drug product expired. Thus, for the drug products that had a generic launch, the study provides data on the actual years of market exclusivity enjoyed by the NDA applicant prior to generic launch. The claims of a patent covering a drug product define its scope and provide the contours of the patent owner’s property rights with respect to that product.
Among other things, the study illustrates that simply quantifying raw numbers of patents and exclusivities is an imprecise way to measure the intellectual property landscape of a drug product because not every patent or exclusivity has the same scope. This study does not address the price of the drug products included in the study or any effect of generic drug launch on price or market share.
The sample size limits generalizations that can be drawn from the study.
Download study Download Excel charts
For questions or inquiries, please email USPTO-FDAcollaboration@uspto.gov.