A US court has ruled that the patent protecting Pulmicort Respules, AstraZeneca's US asthma drug, is invalid, dealing a blow to the company's wallet and allowing generic drugmaker Actavis Inc. to start copying the drug.
The ruling comes at a difficult time for Anglo-Swedish drug giant AstraZeneca, which is battling a steep drop in patent revenues from top-selling drugs such as the cholesterol treatment Crestor and the antipsychotic Seroquel.
The company unveiled a $2.3 billion restructuring plan last month, including thousands of job cuts, just as new Chief Executive Pascal Soriot is seeking new avenues for growth.
AstraZeneca, the District Court for the District of New Jersey reported Tuesday, had ruled in favor of Actavis, which has developed a generic version of the drug. Actavis in a statement on its website said it plans to launch a version of the drug immediately.
AstraZeneca has reported that it has a new generic version of Pulmicort Respules, which could materially impact the royalties it receives from sales of Teva Pharmaceutical Industries Ltd.
Teva brought to market a generic version of the drug following a previous deal with AstraZeneca that dates back to 2008. AstraZeneca said it made about $260 million in royalties in 2012 from this deal.
AstraZeneca reports, however, that the ruling would not jeopardize a broader revenue outlook for 2013 but a single-digit drop in sales.
Total sales of Pulmicort in the United States, including both brand-name and generic versions in the fiscal year ended January 31, 2013, were approximately $1.2 billion, Actavis reported on its website. AstraZeneca last month won a lengthy lawsuit against Actavis to protect revenues on Crestor through 2016. Translation by Riccardo Bevilacqua
Source: Court Rules AstraZeneca's US Pulmicort Patent Invalid April 2, 2013
