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Showing posts from April, 2019

Comments on the FDA’s February 2019 Orange Book raw data

In mid-March the FDA released their February 2019 (Vol. 39, Supp. 2) Orange Book raw data. I updated my Orange Book Companion® right away, but here are a few somewhat overdue observations about Supplement 2:
We had another light month of patent listings. Only 36 new patents were listed in February. Are we still in a New Years hangover? Unlike last month no single product dominated the new listings.
Three patents were delisted well before their expiration dates. I could not find any IPR decisions or patent listing disputes for those patents. One NDA holder delisted two of those patents from one of its products and listed them for another of its products. Maybe just a mix up during the listing process? If so, this is another example of why companies need to pay special attention to their end-to-end patent listing workflow.
Pfizer received a three-year “miscellaneous” exclusivity (M-237) for CHANTIX based upon their completion of a study “to determine whether varenicline, as part of an ove…