And the Orange Book patent listing champion is . . .

Over my years of using the Orange Book Companion® (“OBC”), I have occasionally noticed patent listings for a product that seem to go on forever. At that time I might wonder which product of the many products in the Orange Book has the most patents listed. But other priorities would intervene, and I never did anything to satisfy my idle curiosity until now.

At first I thought that this would take a lot of coding to get the answer from the FDA’s monthly raw data. Then it came to me that the OBC’s “master” table (from which all of the tables that subscribers see are derived) could be my source rather than the FDA’s raw data. Five minutes later I had the answer. It’s a three-way tie at 36 patents per product! The champions of patent listings are:

AFREZZA (insulin recombinant human) from Mannkind Corp.,
BYDUREON PEN (exenatide synthetic) from AstraZeneca AB, and
HYSINGLA (hydrocodone bitartrate) from Purdue Pharma LP.

Not surprisingly, the patent listings for AFREZZA (an insulin product administered by inhalation using a  proprietary device) and BYDUREON PEN (an injectable product administered using a proprietary injection “pen”) are bolstered by a number of device patents. Also not surprisingly, the patent listings for HYSINGLA (an extended-release hydrocodone product with abuse-resistant properties) include a number of formulation patents. 

If you would like an overall view of how the number of products having a given number of patents looks in graphical format, take a look at this:



I left out the products with <10 patents since the numbers skyrocketed so high that it made the rest of the bars look very tiny.

Easy Way to Investigate the Patents of the Three Champions:

For anyone who is interested in an easy way of looking at the Orange Book patent listings for the three “champions” described above, I have added links to their full patent and exclusivity portfolios on the OBC public home page. A subscription to the OBC is not required. Just look for “Orange Book Patent Listing Champions” in the center of the page.The portfolios for the three products are in “Orange Book Companion format” which means that each patent record includes a link directly to the patent at the USPTO, and also shows the patent title, Drug Substance and/or Drug Product flags (if any), Use Codes (if any), the types of claims found in the patent, and the length of a patent extension under 35 USC 156 (if any).

Note to Purdue Pharma LC re HYSINGLA “October 30” Expiration Dates:

Patent 9,572,804 has an expiration date of October 30, 2020 for the 80 and 100 mg strengths of HYSINGLA, but that same patent has an expiration date of October 30, 2021 for the 120 mg strength. I noticed that discrepancy because the OBC algorithm created a separate table for the 80 and 100 mg strengths on one hand and the 120 mg strength on the other. That meant that there had to be some kind of difference between the tables, and led me to discover the difference in the expiration date for the ‘804 patent. This feature of the OBC shows how it can help subscribers discover inconsistencies in their Orange Book listings.

So how did this happen? The ancestry of the ‘804 patent shows that it claims priority back to a non-provisional application that was filed on October 30, 2001 and to a provisional application that was filed on October 30, 2000. Could it be that someone at Purdue (or a legacy company) calculated the 2020 expiration date for the 80 and 100 mg strengths by mistakenly adding twenty years to the provisional filing date rather than the non-provisional filing date? Perdue, that will be your job to investigate. But one of the dates has to be incorrect. You may also wish to investigate whether any of the October 30, 2020 expiration dates are correct, since all of the patents with that expiration date appear to be in the same family as the ‘804 patent. 


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