Showing posts from August, 2022

Orange Book Vol. 42/Supp. 6 News: Watch out for the breadth of your use codes

This posting is late since I am talking about Vol. 42, Supp. 6 of the Orange Book. The data for Supp. 6 was released by the FDA in mid-July. However, I updated my  Orange Book Companion  immediately when the data was released, so my subscribers received the new data on time. Similarly, if you are not a subscriber but enjoy checking out my free  Orange Book Companion  “ What’s New ” each month, that was also ready to view in mid-July. So, what is late? It’s this Supp. 6 news where I discuss a mass delisting of patents for a single product   in which all of the patents had what appears to be overly broad use codes . Please read on.   Supp. 6 added 52 new patents to the FDA’s Orange Book. However, unlike Supp. 5, there were a number of patents that were delisted or were newly tagged as being the subject of a delisting request. Two of four patents listed for Serenity Pharmaceuticals’ NOCTIVA ( desmopressin acetate)   were delisted. Both strengths of NOCTIVA are shown in the Orange Book as