Mixed fortunes for AstraZeneca as the Anglo-Swedish drugmaker won a legal battle to protect its asthma drug Pulmicort Respules but then came under the spotlight over alleged off-label promotion of Seroquel.

First the good news and a New Jersey court has granted AstraZeneca's request for an injunction barring Canadian firm Apotex from selling a copycat version of Pulmicort Respules (budesonide inhalation suspension). The ban stands until a patent infringement trial can be held and there is no date set as yet.

In March, the US Food and Drug Administration granted approval for a generic version of Pulmicort Respules to Apotex, and AstraZeneca immediately weighed in with a lawsuit. Patents covering the drug expire in 2018 with paediatric exclusivity extending to 2019 and AstraZeneca insists it has “full confidence in the strength of the intellectual property rights” protecting the product.

Full-year US sales for Pulmicort reached $982 million in 2008 and about 90% of that total is accounted for by Pulmicort Respules. In November last year, AstraZeneca reached an agreement with Teva which agreed not to resume selling its budesonide inhalation suspension product until December 15 this year and then only under an exclusive licence granted by AstraZeneca.

The drug major will receive a “significant undisclosed royalty” on sales of Teva's product.

Less good news for AstraZeneca has come from the release of documents as part of ongoing litigation in Orlando, Florida concerning Seroquel (quetiapine). The documents, include emails and “strategic plans” which plaintiffs lawyers claim reveal that the company discussed the off-label promotion of the antipsychotic for uses in children and the elderly.

Tony Jewell, a spokesman for AstraZeneca, was quoted by the Wall Street Journal as saying that “these documents do not advocate the inappropriate promotion of Seroquel". Instead, they "show the company was seeking to explore additional indications for Seroquel and included that in clinical-development plans designed to support efforts to investigate potential additional indications".

The company faces around 10,000 lawsuits by patients alleging that Seroquel caused diabetes and other side effects, although not all the cases involve the off-label allegation.