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H., Lee, S., Kang, K

All biologic drugs regulated under the Public Health Service Act are tracked in the separate FDA Purple Book, which has its own, substantially less complete patent information infrastructure Databases like DrugPatentWatch aggregate Orange Book patent listings, FDA exclusivity records, ANDA filing activity, and litigation outcomes into a unified view that shows not just when patents expire on paper, but when meaningful generic competition can realistically begin

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(2007) 293:G28895