Showing posts from May, 2022

Orange Book Vol. 42/Supp. 4 News

Orange Book Insights  No. 33 – Orange Book Vol. 42/Supp. 4 News For those who have not checked yet, in mid-May I posted a link to my free Orange Book Companion “What’s New” for Orange Book Vol. 42, Supp. 4 on my public  Orange Book Companion  home page. Supp. 4 added 52 new patents to the FDA’s Orange Book, and showed the delisting of two patents.    One of the delisted patents was  7,323,463 , that had been listed for Allergan’s COMBIGAN ® . The’463 patent had been the subject of a patent delisting request. So the FDA has now acted on that request. The other delisted patent,  9,593,100 , had been listed for Array Biopharma’s MEKTOVI ®  ( binimetinib ) . The MEKTOVI ‘100 patent had not been the subject of a delisting request.   As I categorized the claims of the fifty-two newly listed patents in order to include that information in my  Orange Book Companion , I noticed one set of claims that was particularly interesting. The patent was  11,311,515  listed for an ophthalmic drug called

Purple Book Companion(TM): April Update Announcement & New Features!

  I have updated the beta version of my  Purple Book Companion ™  through April 2022. The FDA's "Purple Book" contains information about approved biologic drugs. This includes patents that some BLA sponsors assert cover their biologics, as well as exclusivities that may prevent the FDA from approving competitive biosimilars of innovator biologics for a certain period of time. My  Purple Book Companion  focuses only on the listed patents and the granted exclusivities. For biologics that have patents and their expiration dates listed in the FDA's Purple Book, the  Purple Book Companion  (" PBC ") additionally provides the title of each patent, the types of claims in each patent, and further includes a link to the text of the patent at the USPTO. So there is no need to individually copy and paste patent numbers into the USPTO's search utility in order to view the patents. Just click the link. New Features : The original version of the  PBC  only had an inde