Actavis launches generic Pulmicort Respules in USA

14 February 2015

Ireland-based generic drugs major Actavis (NYSE: ACT) has launched its generic version of Anglo-Swedish pharma major AstraZeneca's (LSE: AZN) Pulmicort Respules (budesonide inhalation suspension) 0.25mg and 0.5mg vials

The move follows a ruling from the US District Court for the District of New Jersey that (i) US Patent No 7,524,834 is invalid, and (ii) AstraZeneca's request for a permanent injunction is denied.

Actavis' Abbreviated New Drug Application for its generic version of Pulmicort Respules received final approval from the US Food and Drug Administration in August 2012. The drug is a maintenance medicine used to control and prevent asthma symptoms in children aged 12 months to eight years. For the 12 months ended June 30, 2014 total US brand and generic sales of Pulmicort Respules were around $1.1 billion. Under an agreement with AstraZeneca, Israeli generics giant Teva Pharmaceutical Industries (NYSE: TEVA) has a copy version of Pulmicort Respules on the market.

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