Showing posts from June, 2022

Orange Book Vol. 42/Supp. 5 News

  For those who are interested in month-by-month changes to the patents listed in the Orange Book, and interested in new awards of exclusivity, I posted a link on my public  Orange Book Companion  home page to the free Orange Book Companion “ What’s New ” for Vol. 42, Supp. 5.  Supp. 5 added 44 new patents to the FDA’s Orange Book, and no patents were delisted. However, there was a bumper crop of Patent Term Extensions under 35 USC 156 (eleven, not including one patent that received its second one-year PTE under Sec. 156(e)(2)).  The extended patents have not yet been added to the list of  Sec. 156 extensions  shown at the USPTO. If you want to review the extended patents, just search for the phrase “new expiration date” (without the quotes) in the  What’s New  using your web browser. News has come out recently that Amarin, the Orange Book patent listing champion with 68 patents listed for its 1 gram strength of VASCEPA (icosapent ethyl), is planning a major downsizing in response to s