US court invalidates asthma drug patent

Generics/News | Posted 06/03/2015 post-comment0 Post your comment

The US District Court of New Jersey ruled on 13 February 2015 that the patent protecting AstraZeneca’s inhaled asthma drug Pulmicort Respules (budesonide inhalation suspension) is invalid, opening the door to competition from generics.

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Generics makers Actavis (Watson Laboratories), Apotex and Sandoz argued that AstraZeneca’s ‘834 patent covering Pulmicort Respules (budesonide inhalation suspension) was invalid, claiming the method AstraZeneca used to sterilize budesonide for inhalation was obvious, rather than an innovation.

Generics giant Teva Pharmaceutical Industries already sells a generic version of pulmicort respules under licence to AstraZeneca [1].

US sales of Pulmicort Respules during 2014 were US$946 million. The ‘834 patent protecting Pulmicort Respules expires in 2018, with paediatric exclusivity extending into 2019. Actavis (Watson Laboratories), Apotex, Barr, Mylan and Sandoz have all had generics of the asthma drug approved by the US Food and Drug Administration.

AstraZeneca ‘strongly disagrees with the Court’s decision’, according to Mr Paul Hudson, President, AstraZeneca US and Executive Vice President, North America. The company is considering an appeal.

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1.   GaBI Online - Generics and Biosimilars Initiative. US appeals court halts pulmicort generics []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Mar 6]. Available from: 

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Source: AstraZeneca

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