AstraZeneca has filed a lawsuit against Handa for submitting an Abbreviated New Drug Application (ANDA) for a generic version of SEROQUEL XR to the US Food and Drug Administration.
As per the agreement, Handa accepts that the patents asserted by AstraZeneca in the US patent litigation are valid and enforceable.
Handa received a licence from AstraZeneca to enter the US market with generic SEROQUEL XR on 1 November 2016.
SEROQUEL XR is an extended-release tablet formulation of quetiapine fumarate, used as an add-on treatment to an antidepressant for patients with major depressive disorder (MDD).