AMGN expects Teva to launch Neutroval (Neupogen FoB) in Nov 2013, but AMGN does not expect Teva to launch Neugranin (Neulasta FoB) in Nov 2013, according to AMGN’s 2Q11 CC. In other words, the settlement announced in #msg-65277106 ensures that Teva cannot launch Neugranin before Nov 2013, but it does not grant Teva a license to launch Neugranin in Nov 2013.
These programs seek FDA regulatory approval via the traditional BLA pathway, not the new 351(k) pathway, which implies that they will be non-substitutable for the corresponding branded products from AMGN.
Teva is also a player in the market for Neopogen/Neulasta FoB’s, and it reached a partial patent settlement with AMGN (#msg-65841959, #msg-65308970).
News 
Market Data 
Discover 
