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