Appeals court confirms Pulmicort Respules patent invalid, Actavis re-launches its generic version

Actavis has announced that it is relaunching 0.25 and 0.5 mg vials of budesonide inhalation suspension, a generic version of AstraZeneca’s Pulmicort Respules, after the United States Court of Appeals for the Federal Circuit lifted an injunction preventing Actavis from marketing the product. The court upheld a lower court’s determination that US Patent No. 7,524,834, titled “Sterile powders, formulations, and methods for producing the same,” is invalid.

The company initially launched its generic budesonide inhalation solution in February 2015 after the lower court ruling. AstraZeneca quickly obtained a temporary injunction from the Court of Appeals.

Actavis President and CEO Brent Saunders commented, “We are pleased to be able to supply the market immediately with this product, and we are pleased that the Court of Appeals was able to work so swiftly to address this important matter.”

Read the Actavis press release.

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