By William McQuillen
April 16 (Bloomberg) -- AstraZeneca Plc, the U.K.’s second- biggest drugmaker, won a bid to temporarily block Apotex Inc. from selling copies of the asthma drug Pulmicort Respules.
U.S. District Judge Renee Marie Bumb, in a hearing today in Camden, New Jersey, issued a restraining order to block Toronto- based Apotex’s sales of the drug. The order will remain in effect until at least April 27, when Bumb will consider whether Apotex’s copy should be kept off the market until the underlying patent case is heard.
Apotex received U.S. Food and Drug Administration approval March 30 to sell its version of the drug, known generically as budesonide inhalation suspension. AstraZeneca sued the next day, seeking to block sales until patents expire in 2019.
AstraZeneca, based in London, had U.S. Pulmicort sales of $982 million last year. Sales of the respules accounted for about 90 percent of that total, the company said Jan. 29. In November, AstraZeneca reached an agreement that would keep Teva Pharmaceutical Industries Ltd. from selling a copy of Pulmicort Respules until Dec. 15.
Before that accord, Bumb issued a temporary order preventing Teva, based in Petah Tikva, Israel, from selling its generic version. In granting the request against Teva, Bumb said Nov. 19 that AstraZeneca faced “immediate and irreparable harm” if the temporary ban wasn’t imposed. AstraZeneca settled the following week with Teva, the world’s largest maker of generic drugs.
Teva’s Drug
Teva entered the market briefly after it received FDA approval on Nov. 18 and before the judge’s ruling. AstraZeneca said that, as a result, U.S. sales of Pulmicort Respules fell 18 percent in the fourth quarter.
Teva was allowed to continue selling the generic Pulmicort that had already been shipped, and the copies accounted for 40 percent of all budesonide inhalation suspension sales in December.
AstraZeneca’s American depositary receipts, each representing one ordinary share, rose 94 cents, or 2.7 percent, to $35.85 in New York Stock Exchange composite trading.
The case is AstraZeneca LP. V. Apotex Inc., 09cv1518, U.S. District Court, District of New Jersey (Camden).
To contact the reporter on this story: William McQuillen in Washington at bmcquillen@bloomberg.net.
Last Updated: April 16, 2009 16:34 EDT
HOME
