AstraZeneca filed a case against Indian generic drug maker, Lupin in November 2012 for filing Abbreviated New Drug Application (ANDA) no. 20403 with the U.S. Food and Drug Administration (FDA) seeking approval to manufacture a generic version of AstraZeneca’s Seroquel XR 200 mg extended release tablets. The patent involved in the suit is US5948437 entitled ‘Pharmaceutical compositions using thiazepine’ and is currently assigned[i] to AstraZeneca (source: MaxVal’s Assignment Database). The patent was issued on September 07, 1999 and expires[ii] by May 28, 2017.
Seroquel XR (quetiapine fumarate) is used to treat certain mental/mood conditions (including bipolar disorder and schizophrenia). It works by helping to restore the balance of certain natural substances (neurotransmitters) in the brain.
Now AstraZeneca settled its patent infringement suit against Lupin on 11th of April, reaching a ‘Settlement Agreement’. As per the agreement, Lupin directly or indirectly shall not sell the generic version of Seroquel XR until November 2016, unless specifically authorized pursuant to the settlement agreement.
Judge Joel A. Pisano signed off the consent judgment in which Lupin agreed that the ‘437 patent is enforceable and valid. All the claims and counterclaims were dismissed with prejudice.