Apotex Moves Para IV for Allergan’s Alphagan

Canadian generic drug maker – Apotex has made a Para IV certification with its Abbreviated New Drug Application (ANDA) Nos. 78-479 and 78-480 to manufacture and market generic version of Allergan’s Alphagan P, generically known as brimonidine tartrate 0.15% and 0.10% ophthalmic solutions before the expiration of Alphagan five Orange Book listed patents – US 5,424,078; US 6,562,873; US 6,627,210; US 6,673,337; and US 6,641,834 (collectively “Allergan Patents”). Subsequently Apotex notified Allergan, and in response of which Allergan filed a complaint for patent infringement in the US District Court for the District of Delaware alleging that submission of Apotex’s ANDAs for approval to sell brimonidine tartrate 0.15% and 0.10% ophthalmic solutions before the expiration of Allergan patents will constitutes an act of infringement under USC 35 § 271(e)(2). Allergan patents cover various aspects of the Alphagan P 0.15% and 0.10%.