Showing posts from May, 2024

The Great Delisting! Companies delist patents in response to FTC notices.

The FTC sent letters dated November 7, 2023 to nine pharmaceutical companies stating that the FTC believes: certain patents have been improperly or inaccurately listed in the Orange Book with regard to [name of pharmaceutical company] products and that we have availed ourselves of the FDA’s regulatory process and submitted patent listing dispute communications to the FDA regarding the patents. Below, I discuss products for which the NDA holder delisted some, but not necessarily all, patents as a result of receiving the FTC letters. ARNUITY ELLIPTA, ANORO ELLIPTA ARNUITY ELLIPTA is an inhaled drug indicated for the once-daily maintenance treatment of asthma as prophylactic therapy. The FTC letter for ARNUITY ELLIPTA mentions four patents, but only mentions one strength of the drug. Strengths of a drug are identified in the Orange Book by “Product Number” (“Prod. No.”). For example, in the Orange Book, there are three product numbers for ARNUITY ELLIPTA (fluticasone furoate). Those produ