Upon the April, 2008 expiration of the 30-month Hatch-Waxman stay, the prior FDA tentative approval of [Aricept] ANDAs could then be made a final approval.
Correct, but that 30-month stay pertained to a different patent. Why didn’t the FDA require the ANDA filers to make a Paragraph-IV certification on Eisai’s 4895841 patent?