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Showing posts from June, 2019

New Cocaine Patent, No Exclusivity for Label Expansion Based on Real World Data, and Other Musings About Supp. 4

This blog entry for Orange Book Supplement 4 (April 2019) may be late, but the Supp. 4 update of my Orange Book Companion® was not! In this case, my updating was already complete by the day that the FDA’s “CDER New” newsletter announced the update.
So, what was new in the Orange Book in April? A new patent was listed for GOPRELTO (cocaine HCl 4%). The claims cover the aqueous cocaine solution in an amber bottle. I checked the file and did not find any specific reason for the bottle color limitation. There is now also a stability limitation. Not too surprisingly the claims were rejected, among other things, for obviousness-type double patenting over a previous patent and a pending application. That was overcome by a terminal disclaimer.
Last month I mentioned that it would be interesting to see if Pfizer’s IBRANCE would receive three-year exclusivity for a label expansion to include treating breast cancer in men. This label expansion was based predominately on the latest hot buzz-phrase,…