US court rules patent on AstraZeneca's Pulmicort Respules invalid

AstraZeneca announced Tuesday that a US district court ruled that a patent protecting Pulmicort Respules (budesonide) is invalid and that generic versions of the product do not infringe a second patent on the asthma therapy. "AstraZeneca strongly disagrees with the court’s decision," remarked Paul Hudson, the drugmaker's executive vice president for North America, adding that the company "is considering next steps, including an appeal."

AstraZeneca filed patent lawsuits against Actavis, Apotex and Novartis' Sandoz unit alleging that the companies' proposed generic versions of Pulmicort Respules infringed one patent covering the drug’s delivery method and another related to its formulation. The patents expire in 2018, with paediatric exclusivity extending into 2019, the UK company noted. Actavis indicated that following the court ruling, it will immediately launch its generic version of Pulmicort Respules in the US.

According to AstraZeneca, the decision is restricted to the US and is not expected to alter its annual revenue guidance, which sees a mid to high-single digit decline in sales for 2013. The company noted that sales of Pulmicort Respules last year were approximately $136 million, while the drugmaker received royalty payments from Teva of approximately $260 million related to a generic version of the product launched in December 2009 under an earlier settlement deal. AstraZeneca noted that the royalty payment from Teva "will decline" due to the launch of additional generic versions.

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