Astra settles Seroquel dispute with Handa

30th Sep 2011 08:02

Drugs giant AstraZeneca has come to an accommodation with generic drugs rival Handa Pharmaceuticals over their legal dispute regarding Astra's Seroquel XR drug.The agreement settles the patent infringement litigation filed by AstraZeneca following Handa's submission to the US Food and Drug Administration (FDA) of an Abbreviated New Drug Application (ANDA) for a generic version of Seroquel XR. For Astra, the key element of the deal is that Handa has agreed not to dispute that both patents asserted by AstraZeneca in the US patent litigation are valid and enforceable. "We believe this agreement reaffirms our intellectual property rights and is the right business decision for AstraZeneca at this time," said David Brennan, chief executive of AstraZeneca. Astra still has to fight off attempts by other generic drug makers who intend to launch generic forms of Seroquel XR. A trial in a US federal court is set to start next Monday in which Astra will seek to defend its Seroquel XR patents against five generic drugs makers.Seroquel is Astra's second biggest money-spinner, and generated revenue of more than $5bn got Astra in 2010, so the stakes are high for the Anglo-Swedish pharmaceuticals company. For Handa, the beneficial part of the agreement is that AstraZeneca has granted it a licence to enter the US market with generic Seroquel XR on 1 November 2016 or earlier upon certain circumstances. Seroquel XR is protected by patents and other exclusivity rights that range from March 2012 to November 2017.Astra said the settlement will have no impact on financial guidance for the current year. --jh