LONDON – AstraZeneca has suffered a fresh patent setback with a U.S. court decision that a patent protecting its Pulmicort Repsules asthma treatment is invalid, clearing the way for a generic copy from Actavis.
The ruling comes as AstraZeneca is already facing a big fall in sales due to patent expiries on other medicines, prompting a $2.3 billion restructuring plan and further job losses announced by new CEO Pascal Soriot last month.
AstraZeneca said on Tuesday it strongly disagreed with the court's decision and was considering next steps, including lodging an appeal.
The District Court for the District of New Jersey ruled in favor of Actavis, which has developed a generic version that it now intends to launch immediately.
The verdict will not change AstraZeneca's revenue guidance for 2013, which is that the company anticipates a mid to high-single digit decline in sales.
But Britain's second-biggest drugmaker said additional generics entering the U.S. market would materially impact royalties received on sales of Teva's existing generic version of Pulmicort Repsules. Teva already has a generic on the market following an earlier deal with AstraZeneca.
Total branded and generic sales of Pulmicort Repsules were around $1.2 billion in the United States in the 12 months to January 2013, according to Actavis.
(Reporting by Ben Hirschler; Editing by Louise Heavens)