Nexium and Seroquel face US generic fight
pharmafile | March 20, 2008 | News story | Sales and Marketing |Â Â Â
AstraZeneca is to face a crucial court battle over one of its biggest brands, Seroquel.
Generics companies Teva and Sandoz are challenging the drug's US patent, which runs until 2011, and an August date for the challenge has now been set.
Loss of Seroquel revenues would be a major blow to AZ's portfolio if New Jersey's US District Court rules in favour of the challengers.
Teva and Sandoz may launch a generic version ahead of a ruling as early as April, although this would mean they would have to pay damages should the judge uphold AZ's patent.
Earning global sales of $4 billion last year Seroquel is one of the company's most profitable medicines, and analysts believe AstraZeneca has a strong defence. An AZ spokesman said: "We remain confident in the validity and enforceability of the Seroquel patent and that AstraZeneca will prevail at trial."
Meanwhile, the company is seeking to extend the indications for the drug, asking US and European regulators for permission to sell it as a treatment for bipolar disorder as well.
AstraZeneca's biggest selling drug Nexium is also under attack, but analysts are less confident the company can repel a challenge on its patent.
The anti-ulcer pill earned the company $5.2 billion last year, and has US patent coverage until 2018, but could also be toppled this year.
Concerns about generic competition to the two brands have already had a financial impact, pushing shares down by around 15% since the end of last year.
A variety of companies are interested in producing generic versions of Nexium, and AZ has cases pending against Teva, Ranbaxy Laboratories and Dr. Reddy's Laboratories. The stakes are high: Mirabaud Pereire Holdings investment analyst Nick Turner was quoted as saying: "Growth in AZ in the next five years depends on Nexium and Seroquel. If they lose these patents the company will go into a tailspin."
AstraZeneca has already sued Teva in 2005 and Sandoz in April 2007 in a bid to stop cheaper versions of Seroquel hitting the market.
