>Can anybody educate the board on how Apotex can claim the 6-month exclusivity for being first to file does not hold anymore?<
Apotex is taking the position that MYL is not entitled to the six-month Hatch-Waxman exclusivity because MYL will not launch its generic Norvasc until after the patent in question was set to expire on its own on 3/25/07. I.e. the earlier than previously-expected launch of generic Norvasc will be due to PFE’s loss of the pediatric extension period (which would have run until 9/25/07) rather than the loss of the patent per se.
In my opinion, Apotex’s argument is a bluff; what Apotex actually wants is to negotiate with Mylan from a position of strength.
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