Actavis has been blocked from selling its generic version of AstraZeneca’s asthma drug Pulmicort Respules five just days after the product was launched.
The US Court of Appeals granted AZ a temporary injunction on the sale of Actavis 0.25mg and 0.5mg formulations of the budesonide inhalation suspension, pending an appeal of the judgment last week that overturned a key US patent on the product.
“Actavis’ sales of generic Pulmicort have been enjoined pending a hearing on the temporary injunction,” said the generic pharma manufacturer in a statement.
However, it could be that AZ’s reprieve is short-lived. “A response for the hearing is due to the court from Actavis by February 20,” it added, noting that the temporary injunction “does not address product shipped prior to its issuance.”
For the 12 months ended June 30 2014, total sales of Pulmicort Respules and an authorised generic sold by Teva were approximately $1.1bn.
AZ revealed earlier this year it had Pulmicort sales of $946m in 2014, up 11% on the prior year, and also indicated it had received $260m in royalties on sales of Teva’s version.
The invalidated patent (No. 7,524,834) was set to expire in 2018 and had paediatric exclusivity extending up to 2019.
The early onset of generic competition would exacerbate a tricky period for AZ, which lost patent protection for gastrointestinal therapy Nexium (esomeprazole) in a number of markets including the US – prompting a 6% decline in US sales to $3.87bn last year and with an even greater impact expected in 2015.
Moreover, AZ will lose protection for its biggest selling product – the cholesterol drug Crestor (rosuvastatin) – in 2016, placing annual sales of more than $5.5bn in jeopardy, equivalent to 21% of the company’s total annual revenues.