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.

Comments

Post a Comment

Popular posts from this blog

Orange Book Vol. 42/Supp. 6 News: Watch out for the breadth of your use codes

This posting is late since I am talking about Vol. 42, Supp. 6 of the Orange Book. The data for Supp. 6 was released by the FDA in mid-July. However, I updated my  Orange Book Companion  immediately when the data was released, so my subscribers received the new data on time. Similarly, if you are not a subscriber but enjoy checking out my free  Orange Book Companion  “ What’s New ” each month, that was also ready to view in mid-July. So, what is late? It’s this Supp. 6 news where I discuss a mass delisting of patents for a single product   in which all of the patents had what appears to be overly broad use codes . Please read on.   Supp. 6 added 52 new patents to the FDA’s Orange Book. However, unlike Supp. 5, there were a number of patents that were delisted or were newly tagged as being the subject of a delisting request. Two of four patents listed for Serenity Pharmaceuticals’ NOCTIVA ( desmopressin acetate)   were delisted. Both strengths of NOCTIVA are shown in the Orange Book as
Read more

Orange Book V43, Supp. 1 news

  Happy Orange Book New Year! Volume 43, Supp. 1 added 41 new patents to the FDA’s Orange Book. That includes three new patents for the current patent listing champ, AUVELITY® which now has 103 patents listed. You can see all of the changes to the Orange Book that occurred in Vol. 43/Supp. 1 by going to the Orange Book Companion® public home page and clicking on the prominent “What’s New” link.  If are a gluten for punishment, can also see all 103 AUVELITY patents by clicking the sample link for trademarks that begin with "A" and then scrolling down to AUVELITY. A device for making a drug does not claim the drug, itself Three particularly interesting patents were listed in the Orange Book as part of Volume 43/Supplement 1. All three patents claim devices for making the approved drug. They do not claim the approved drug, itself, or a method of using the approved drug. Yet all three were listed as “drug product” patents.  In each case, the approved product is a gas that is con
Read more

Make sure that your patent exists before submitting a 3542 form for the patent to the FDA

 So, you received an “Issue Notification” from the USPTO for an allowed patent application. Yay! But be careful! The “Issue Notification” document that the USPTO sent you says that it merely contains a “ projected ” patent number and issue date.  In the case of MC2 Therapeutics’ WYNZORA, a patent with the projected patent number that the Issue Notification contained did not issue on the projected issue date, and, in fact, never issued! However, MC2 must have submitted a 3542 form to the FDA for patent number 11638711 (‘711 patent) that was contained in an Issue Notification that had been sent to them on April 12, 2023. That Issue Notification said that the patent would issue on May 2, 2023. The Electronic Orange Book shows that information for the ‘711 patent was received by the FDA for WYNZORA on May 31. However, in my preparation for the Vol. 43/ Supplement 6 version of my Orange Book Companion® I discovered that one of the text files of basic data that my algorithms had generated fo
Read more