Comments on the FDA’s March 2019 Orange Book raw data (plus a coming attraction!)

Last week the FDA released their March 2019 (Vol. 39, Supp. 3) Orange Book raw data. Here are a few observations about Supplement 3:

We had another light month of patent listings. Only 37 new patents were listed in March. Most surprising was the lack of patents claiming new compounds. Only one of the newly listed patents had traditional compound claims.

Two patents were delisted in March, and unlike in February the reasons were quite obvious. The patent that was listed for Kaleo’s EVZIO (AUTOINJECTOR) as a result of a typo in the patent number has been delisted and replaced by the correct patent, 10,143,792. The other delisting was carried out because 9,085,601 that had been listed for Astellas’ LEXISCAN was reissued.

Here is something to look for in the April (Supp. 4) data that will be released by the FDA in mid-May. On April 4 the FDA approved Pfizer’s IBRANCE in combination with an aromatase inhibitor or fulvestrant for HR+, HER2- advanced or metastatic breast cancer in men. Since that is the same indication as for women, you might ask what’s the big deal here?

The big deal is how the data needed to seek approval of this expanded indication for IBRANCE was obtained. In the sub-headline to their April 4 press release, Pfizer stated that the expanded indication was “based predominately on real-world data.” In this case it was electronic health records and post-marketing reports from three databases that provided the data. For more information on real world data and the related real world evidence see the FDA’s “Real World Evidence” page.

So what will we be looking for in the mid-May release of Supplement 4 of the Orange Book? We will be looking to see if the FDA granted Pfizer a three-year Hatch-Waxman exclusivity for this expanded indication for IBRANCE. It is my hope that the FDA will use the three-year exclusivity as an incentive for companies to base supplements on real world data. But we will have to wait to see what the FDA’s decision was, since Orange Book exclusivities are only updated once a month.


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