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Showing posts from February, 2019

Happy Orange Book New Year! Comments on the FDA’s January 2019 raw data

Welcome to the start of a new Orange Book year! We are now in Volume 39. Early last week, the FDA released their January 2019 (Vol. 39, Supp. 1) Orange Book raw data. So I went right to work updating my Orange Book Companion®. Here are a few observations about Supplement 1:
We had a light month of patent listings. Only 35 new patents were listed. Maybe a New Years hangover? That number has to be considered even lighter when we take into account that over half of those 35 patents were listed for a single product! Acorda’s INBRIJA (levodopa) had 18 patents listed. INBRIJA is an inhalable levodopa for treating Parkinson’s disease. Uncharacteristically for an inhaled drug, none of the 18 patents are directed to the inhaler device.
We have a new process patent in the Orange Book. The claims are all directed to “a method of making a gel.” Unlike last month’s process patent, the claimed process is directed to making a product directly related to the approved drug. That makes 11 process pate…