AstraZeneca PLC said Thursday it has reached a settlement with privately held Handa Pharmaceuticals LLC that will keep the company from selling a generic form of its Seroquel XR anti-psychotic medicine in the United States until late 2016.
AstraZeneca said the settlement does not resolve ongoing patent battles with other generic drugmakers that also aim to launch generic forms of Seroquel XR.
The pill is a longer-acting form of Seroquel, which also treats schizophrenia and bipolar disorder. The drugs have combined annual U.S. sales of about $4 billion, of which Seroquel XR accounts for roughly $750 million.
Worldwide annual sales of the Seroquel franchise were $5.3 billion in 2010 -- making the products the company's second biggest seller behind its cholesterol fighter Crestor.
Wall Street is expecting generic forms of basic Seroquel to hit the U.S. market in April 2012, when the U.S. patent on the drug's active ingredient lapses. The cheaper generics would likely soon wrest away the lion's share of the medicine's U.S. sales unless Astra is successful in switching patients over to the longer acting drug.
But AstraZeneca has contended that other patents protect Seroquel XR from 2012 to November 2017, including technology to extend the time the medicine remains active in the bloodstream.
The London-based drugmaker said the Handa settlement will allow the tiny California company to introduce its generic form of Seroquel XR on Nov. 1, 2016, or earlier, under certain circumstances.
U.S. regulators approved Seroquel XR in May 2007 for schizophrenia.
© 2016 Thomson/Reuters. All rights reserved.