Purple Book Companion™ (beta) Announcement

In a January, 2021 Orange Book Insights posting, I reported that the Purple Book for biologic products might soon start including patents. Based upon that news, I was looking forward to creating an enhanced way to look at biologics patents in the same way that my Orange Book Companion® gives users an enhanced way of looking at Orange Book patents. 

So I am now happy to announce the availability of a beta version of my Purple Book Companion™ (“PBC”)! Since this is a beta, it is free for everyone to use. So please take advantage of this offer, and please send any comments, questions, or suggestions that you might have to the email address found on the PBC homepage.

Since Purple Book patent listings are fairly new, and were only required on a prospective basis, there are not a lot of such listings. In fact, there are only four products for which patents have been submitted to the FDA:

* Avastin® (from Genentech): 22 patents

* Humira® (from Abbvie): 65 patents

* Lucentis® (from Genentech): 11 patents, and

* Neulasta®/Neulasta® Onpro (from Amgen): 1 patent

Before patents were listed in the Purple Book, there were already exclusivity listings in the Purple Book. So the PBC also includes those. I found three types of exclusivity that are listed in the FDA’s current Purple Book data:

* Reference Product Exclusivity: 13 products

* Interchangeable Product Exclusivity: 2 products

* Orphan Drug Exclusivity: 176 products

The FDA’s Purple Book data contains some expired exclusivities. In this beta version, I did not do anything to remove them. For the Orange Book, the FDA removes expired patents and exclusivities on an annual basis when they release Supplement 1 of the latest Orange Book volume each February.

The FDA’s Purple Book data does not include any information on the Orphan Drug indication that is protected by the exclusivity. The FDA’s Orange Book currently includes numbered descriptions of orphan indications for small molecule drugs. Prior to the FDA’s addition of those numbered Orphan Drug descriptions to the Orange Book, I used a system for my Orange Book Companion by which I extracted the descriptions from the FDA’s Orphan Drug database.

For most PBC products, I managed to resurrect my prior system so that users of the Purple Book Companion can have that additional information. Unfortunately, due to slight differences that sometimes occur between the contents of the “Proprietary Name” and “Trade Name” fields in the Purple Book and in the Orphan Drug Database, respectively, my automated retrieval of orphan indications from the FDA's Orphan Drug Database might not succeed in all cases. So before making a business critical decision, always double check the official source, such as FDA’s Orphan Drug Database. However, since the Purple Book’s orphan drug data only includes the date of the last-to-expire orphan exclusivity for a drug, my automated extraction system will provide you with most, if not all, of the many orphan indications and their expiration dates that could currently be protecting a drug.

I hope that everyone who is interested in patents and exclusivities for biologic products will find my Purple Book Companion useful.  Please feel free to send me any comments, questions, and suggestions that you might have to the email address found on the PBC homepage.

#patents #fda #hatchwaxman  #drugpatents #orangebook #orangebookpatents #orangebookinsights #orangebookcompanion #purplebook #biologics #purplebookcompanion #BPCIA


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