US appeals court halts Pulmicort generics

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US appeals court halts Pulmicort generics

Generics/News | Posted 31/05/2013 0 Post your comment

On 25 May 2013, the US Court of Appeals for the Federal Circuit issued a temporary injunction in the US stopping generics of AstraZeneca’s asthma treatment Pulmicort Respules (budesonide inhalation suspension).

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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Source: AstraZeneca