AstraZeneca is trying to head off the threat of generic competition to its blockbuster Seroquel schizophrenia drug by seeking a summary judgment in a lawsuit in federal court in New Jersey. Teva Pharmaceuticals is challenging Seroquel patents and could launch in the US as early as the end of March, once a 30-month stay on approval is lifted. Such an early launch would leave Teva exposed to paying damages if a court later backed AstraZeneca’s patent position, but generic companies are increasingly pursuing such “at risk” launches. Seroquel had sales of $4 billion last year. (Read more).

Ranbaxy Laboratories received tentative FDA approval for a generic version of AstraZeneca’s Nexium heartburn med. The generic drugmaker has first-to-file status, providing a potential 180 days of exclusive marketing when the patent on Nexium expires. An automatic 30-month legal stay on generic versions of the drug will be lifted on April 14. AstraZeneca says its Nexium patents that are legally valid from 2009 to 2019. Ranbaxy could launch in April once it gets final approval, but risks a legal challenge from AstraZeneca. Nexium had sales of $5.5 billion. (Read more).

An unnamed company has filed a generic drug application for Lilly’s Cialis impotence pill, suggesting an attempt to bring a copycat version significantly earlier than dictated by Lilly’s patents. The FDA doesn’t identify the filing company, or possibly multiple companies, and the legal process dictates that it could be months before it is revealed who made the filing. Though Cialis is protected by five patents with dates ranging from 2016 to 2020, following the expiration of exclusivity in November 2008, a generic company can seek to market its version by showing that the patents are not infringed or invalid. “I didn’t see it coming,” says Miller Tabak analyst Les Funtleyder, stressing that such challenges are cheap to file and that it makes sense for companies to do so in order to be the first to file. “It certainly won’t help Lilly nor the (drug) group because everyone realizes that there is are a lot of patents that are set to expire.” Cialis had $1.14 billion in sales. (Read more).