The injunction prevents generics manufacturers from distributing generic versions of Pulmicort Respules until the court rules on AstraZeneca’s appeal of a District Court decision in April 2013 that found the patent No. 6,598,603, or the ‘603 patent’ protecting the product to be invalid and a second patent No. 7,524,834, or the ‘834 patent’ not to be infringed.

As a condition of the injunction, the US Court of Appeals has also ordered that AstraZeneca post a bond in the amount of US$72 million.

The Anglo-Swedish drugmaker has stated that ‘it intends to vigorously defend the intellectual property rights protecting Pulmicort Respules’.

Generics giant Teva Pharmaceutical Industries already sells a generic version of Pulmicort Respules under licence to AstraZeneca.

US sales of Pulmicort Respules during 2012 were US$136 million. The patent No. 6,598,603, or the ‘603 patent’, protecting Pulmicort Respules expires in 2018, with paediatric exclusivity extending into 2019.

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