The US House of Representatives on Wednesday unanimously passed two bills that would increase the utility of the US Food and Drug Administration’s (FDA) Orange Book for generic drugmakers and Purple ...

In 2021, the FDA’s Purple Book went live, providing a searchable database of licensed biological products, including the patent information provided to biosimilar applicants during the patent dance.

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The US Food and Drug Administration (FDA) on Monday unveiled the first version of its searchable online database of biological product information, known as the Purple Book. Building off the previous ...

FDA’s Purple Book provides a searchable database of licensed biological products and includes the patent information provided to biosimilar applicants during the BPCIA patent dance. Pursuant to a law ...