EGRX will launch liquid Angiomax product “at risk” as soon as it receives FDA approval, according to CEO Scott Tariff on today’s PJ webcast. (The PDUFA date is 3/19/16). Tarriff thinks the risk from a MDCO lawsuit is de minimis insofar as EGRX’s liquid formulation of Angiomax is vastly different from MDCO’s lyophilized product and hence it does not infringe MDCO’s patents.
Note: MDCO never sued EGRX for patent infringement following EGRX’s 505b2 Paragraph-IV notice, so there is no 30-month Hatch-Waxman stay on FDA final approval.
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