"What's New" Giveaway Announcement

Orange Book Insights No. 28: I recently thought of a new way to introduce users of the FDA’s “Orange Book” to my enhanced alternative, the Orange Book Companion® (“OBC”). I am doing this by giving something away for free. This is something that everyone who is interested in Orange Book patent and exclusivity information will be able to access, and I intend to continue providing this free information at least through 2022.

So, what am I giving away? It is the OBC’s monthly “What’s New” file, currently based, as of the Jan. 15, 2022 publication of this blog posting, on Volume 41, Supplement No. 12 of the FDA’s monthly PDF Orange Book Cumulative Supplement. Each month the OBC's "What's New" will change  as the FDA publishes their monthly Cumulative Supplements.

The OBC's What’s New file is a highly enhanced alternative to the “Patent And Exclusivity Drug Product List” found in each FDA monthly Cumulative Supplement.  Until now the OBC’s monthly What’s New file has only been available to OBC subscribers. However, for at least 2022, my monthly What’s New file will be available to anyone who goes to the OBC’s public home page and clicks on the very prominent link.

I create my What’s New file each month from the raw data that the FDA releases along side with their monthly Cumulative Supplement (both being released by the FDA about two weeks following the end of the month covered by the Cumulative Supplement). However, my What’s New is very compact since it only includes products that had a change in their patent or exclusivity listings for the supplement month in question. As its name suggests, the FDA’s Cumulative Supplement contains all of the changes that have occurred since Supplement 1 of each year, and requires users to read through the patent and exclusivity section of each new monthly Cumulative Supplement looking for the “>A>” tags that identify that month’s changes to patents and exclusivity. I felt that it would be simpler to not accumulate Orange Book patent and exclusivity changes in my monthly What’s New file since OBC subscribers have access to historical What’s New files that go back almost twenty years.


 The OBC’s monthly What’s New has many features that the FDA’s Cumulative Supplement does not. So please go to the OBC’s public home page and click the very prominent link to see for yourself. However, two of the most notable additional features are:


1)    the What’s New file contains a description of each change that occurred that month to the patents and/or exclusivities of a product. This can save users from the detective work needed to determine what actually changed; and

2)    each patent number in the What’s New file is a link to the text of the patent at the USPTO. So there is no need to copy and paste individual patent numbers from the FDA’s Cumulative Supplement into the USPTO’s search screen in order to see the patents.


On a monthly basis I will be announcing the availability of the latest OBC What’s New on my blog (Orange Book Insights™), and on the LinkedIn® Hatch-Waxman ANDA Litigation Forum. So please feel free to subscribe to my blog so you will not miss my announcements. Alternatively, if you are a LinkedIn member and are not already one of the over twelve-thousand members of the excellent Hatch-Waxman ANDA Litigation Forum, please join the forum for its informative discussions and, of course, my monthly What’s New announcements.

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