Orange Book Insights^TM

Orange Book Insights No. 29 – When are eight 0.5g capsules not equivalent to four 1g capsules?  Amarin is still keeping its patent attorneys busy. The Supplement 10 “What’s New” of my Orange Book Companion showed that they listed two more patents for VASCEPA® (icosapent ethyl). Patents Nos. 11,116,742 and 11,154,526 made it 66 patents listed for VASCEPA 1g, and 63 patents listed for VASCEPA 500mg (“half-gram”).  While the ‘742 and ‘526 patents were listed for both the 1g and half-gram strengths of VASCEPA, that new listing started me wondering about the three patents that were listed for the 1g strength but were not listed for the half-gram strength. With 63 patents in common, what was so different about those three patents that Amarin did not list them for the half-gram strength? After all, shouldn’t claims that cover a method of treatment by administering a certain dosage of icosapent ethyl cover the use of both the 1g and half-gram strengths of VASCEPA? Just administer the correc

Orange Book Insights No. 28:  I recently thought of a new way to introduce users of the FDA’s “Orange Book” to my enhanced alternative, the Orange Book Companion ® (“OBC”) . I am doing this by giving something away for free. This is something that everyone who is interested in Orange Book patent and exclusivity information will be able to access, and I intend to continue providing this free information at least through 2022. So, what am I giving away? It is the  OBC ’s monthly “ What’s New ” file, currently based, a s of the Jan. 15, 2022 publication of this blog posting,  on Volume 41, Supplement No. 12 of the  FDA’s monthly PDF Orange Book  Cumulative Supplement . Each month the OBC' s " What's New " will change  as the FDA publishes their monthly Cumulative Supplements . The OBC 's  What’s New  file is a highly enhanced alternative to the “ Patent And Exclusivity Drug Product List ” found in each FDA monthly Cumulative Supplement .   Until now the  OBC ’s month