Biotech Values

[DewDiligence]

Well done! Aricept is indeed a case where the FDA granted final approval for one or more generics and yet no generic has been launched.

Follow-up question: Eisai’s 4895841 patent, which is listed in the Orange Book, runs until 11/25/10, so why did the FDA grant final rather than tentative approval for the Aricept generics from Teva and Mutual Pharma?

p.s. JNJ’s Levaquin is another answer to the original quiz question. The issue in that case was whether the Levaquin patent was eligible for the statutory Hatch-Waxman extension even though Levaquin is merely a single-isomer formulation of Floxin.