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 several VASCEPA ANDA approvals. Hikma, Dr. Reddys and Apotex have all received approval of their 1 gram icosapent ethyl products. This is a good example that merely having a lot of patents listed for a drug is not the answer to fending off generic competition. Possibly, the degree to which icosapent ethyl is difficult to manufacture may have protected Amarin’s market share to some additional extent. Amarin mentioned that difficulty in their 2020 10-K (at p. 37):
Additionally, while we believe that VASCEPA is difficult to manufacture and that building capacity to manufacture VASCEPA is time-consuming and expensive. These factors limit the amount of VASCEPA supply available to generic companies, as experienced by Hikma. (emphasis added).
Hikma’s ANDA was approved in June, 2020.
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