Apotex is out of luck. AstraZeneca has won an injunction against the generics maker's launch of copycat Pulmicort Respules, at least until the federal court can hear a patent-infringement trial. As you know, Apotex already has FDA approval for its version of the asthma drug, but AstraZeneca says it's patent-protected through at least 2018.
Blair Hains, a spokesman for AstraZeneca, told Bloomberg that the company is pleased with the decision. "We continue to have full confidence in the strength of the intellectual property rights protecting Pulmicort Respules," he said. A date for the trial has not yet been set.
Whatever happens with the Apotex trial, a generic version of the $900 million Pulmicort Respules will hit the market at the end of this year. That's because AstraZeneca inked a deal with Teva Pharmaceutical Industries for an authorized generic. AstraZeneca will collect royalties on Teva's sales, and Teva gets an exclusive license for the copycat form. So in fighting off Apotex, AstraZeneca isn't just helping itself--but making sure Teva's way remains clear.
- check out the AstraZeneca release
- read the Bloomberg story