AstraZeneca Settles US Seroquel Xr Patent Infringement Litigation With Handa

AstraZeneca announced that it has entered into a settlement agreement in its U.S. Seroquel Xr patent infringement litigation against Handa Pharmaceuticals regarding Handa's proposed generic version of AstraZeneca's Seroquel Xr or quetiapine fumarate extended-release tablets.

The company said that agreement settles the patent infringement litigation filed by AstraZeneca following Handa's submission to the U.S. Food and Drug Administration of an Abbreviated New Drug Application for a generic version of Seroquel Xr.

As per the settlement agreement, Handa does not dispute that both patents asserted by AstraZeneca in the U.S. patent litigation are valid and enforceable.

As part of the agreement, AstraZeneca stated that it has granted Handa a license to enter the U.S. 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.

AstraZeneca noted that the company and Handa will file a proposed Consent Judgment with the U.S. District Court for the District of New Jersey requesting the Court dismiss the pending legal action between AstraZeneca and Handa. The remaining Seroquel Xr patent infringement litigations remain on-going, the company said.