AstraZeneca in patent settlement deal with Handa over Seroquel XR

Anglo-Swedish drug major AstraZeneca (LSE: AN) yesterday revealed that it has entered into a settlement agreement in its US Seroquel XR (quetiapine) patent infringement litigation against California, USA-based Handa Pharmaceuticals, regarding Handa’s proposed generic version of the blockbuster drug, which is indicated for the treatment of depression and bipolar disorder.

Handa was the first company to file an Abbreviated New Drug Application with the US Food and Drug Administration, gaining tentative approval on December 13, 2010, for 50, 150, 200 and 300mg tablets of Seroquel XR and said it believed it was the first to file a Paragraph IV containing certification under the provisions of the Hatch-Waxman Act, which would give the copy drugmaker 180 days of marketing exclusivity for these tablet strengths on receipt of final regulatory approval.

AstraZeneca is still pursuing patent law suits against five other generic drugmakers, including Mylan, over Seroquel XR, US sales of which were around $750 million last year. Total turnover of Seroquel reached $5.3 billion last year, with around $4 billion coming from the USA.