The FDA released Feb. 24 the first version of the Purple Book, a new online database of biological product information. The Purple Book is modeled after the Orange Book, a list of every ...

Withdrawing from the Orange Book doesn’t preclude a legal battle once a generic reaches the market, but a patent outside the FDA database won’t trigger the 30-month stay.

FDA’s Orange Book Listing Process: FTC Formally Joins the Fray. Michael Abernathy, J. Clayton Everett, Jr., R. Brendan Fee, Maarika Kimbrell, Kathleen Sanzo. Morgan Lewis - As Prescribed ...