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Showing posts from January, 2020

Update on the “Raising Arizona” Metaphor Missing Patent for OSENI

Back in October I blogged about an Orange Book listed patent, 6,329,404, that disappeared from the Orange Book for one of six strengths of Takeda’s OSENI® (alogliptin benzoate/pioglitazone HCl). The FDA had apparently not updated the expiration date for the 12.5/45mg strength (Prod. No. 006) when Takeda filed their 3542 form to inform the agency that their patent had received a Patent Term Extension (“PTE”). The patent’s expiration date had been updated for the five other OSENI strengths. So when the 2017 Orange Book was prepared, the FDA deleted the ‘404 patent from Prod. No. 006 due to its original, unextended expiration date in 2016 still being shown.
In addition to my blog posting, I made a phone call and sent an email to the Takeda contact person listed on their 3542 form. However, I never received a response. So I decided to take the bull by the horns and let the Orange Book Staff know about the missing patent. Unfortunately, this was about the same time as my wife and I were g…