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Healthcare

UPDATE 1-US court bars generic of AstraZeneca asthma drug

* Hearing to extend restraining order set for April 27

* Astra says confident in intellectual property rights

NEW YORK, April 16 (Reuters) - A U.S. court on Thursday granted a temporary restraining order that bars Apotex from selling a generic version of AstraZeneca’s lucrative Pulmicort Respules asthma medicine, the British drugmaker said.

The U.S. District Court for the District of New Jersey is expected to hold a hearing on April 27 to determine whether the injunction should be continued, AstraZeneca AZN.L said.

Astra filed a patent infringement lawsuit against Apotex earlier this month to stop the privately held Canadian company from selling the generic before its U.S. patents expire.

Apotex was granted approval for a generic version of the asthma medicine from U.S. health regulators.

“AstraZeneca has full confidence in the strength of its intellectual property rights protecting Pulmicort Respules and will continue to vigorously defend and enforce its intellectual property,” the company said in a statement.

Apotex did not immediately return calls seeking comment on the court decision.

Pulmicort had U.S. sales of $982 million in 2008 with about 90 percent of that coming from the form of the medicine that is being disputed in the patent case.

AstraZeneca in November reached a settlement with Israel-based Teva Pharmaceutical Industries Ltd <TEVA.TA, the first generic drugmaker to gain FDA approval to sell cheaper copies of the asthma medicine.

Under terms of that deal, Teva agreed not to resume selling its version of the drug until Dec. 15, 2009 under an exclusive license from AstraZeneca for which Teva will pay a royalty on sales of the generic.

Teva also conceded that AstraZeneca’s Pulmicort patents were valid and enforceable and that its generic infringed AstraZeneca’s patents. That settlement ended litigation between the two companies in New Jersey federal court.

Astra had warned that its profit could be hurt by generic Pulmicort. The vast majority of a branded drug’s revenue quickly evaporates once cheaper generics flood the market. (Reporting by Bill Berkrot; Editing by Toni Reinhold)

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