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 index of biologics by trademark. This April revision enhances the usefulness of the PBC by adding indices that are alphabetical by generic name and BLA sponsor. The BLA sponsor index makes it easy to see the biologics that a BLA sponsor owns that have Purple  Book-listed patents and/or exclusivity protection.

Another new feature, starting with the April 2022 edition of the PBC, is a monthly “What’s New.” That page will highlight the changes to the Purple Book patent listings and exclusivities that occurred in the most recent month. In the April 2022 edition, there were no changes to the exclusivities or listed patents from the March 2022 edition.


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