High Court rules against Seroquel XR patent
pharmafile | March 23, 2012 | News story | Sales and Marketing | Accord, AstraZeneca, Sandoz, Seroquel, Teva
A British High Court has ruled that AstraZeneca’s patent on its new formulation of the antipsychotic Seroquel is invalid.
Seroquel XR (quetiapine fumarate) is a prolonged-release form of the firm’s big selling treatment Seroquel, which is licensed to treat schizophrenia and bi-polar disorder.
The patent has been challenged by a number of generic firms – including Accord Healthcare Limited, Sandoz and Teva UK.
AstraZeneca was hoping to preserve its rights on that drug by creating an extended-release version – called Seroquel XR – with a formulation patent that was to expire in May 2017.
AZ said this is the first ruling against the company on this matter. It has already won a case in the Netherlands and is dealing with similar actions in the US and Spain.
The firm said it was disappointed with the UK court’s decision, but said it remained “committed to defending its intellectual property protecting Seroquel XR”.
Seroquel’s UK patent expires this month and one was of the most costly medicines for the NHS in England, which spent £93 million on the drug in 2010.
The Seroquel brand is AstraZeneca’s second-best seller behind cholesterol drug Crestor, and accounted for 17% of the company’s $33.6 billion worth of sales last year – sales of Seroquel XR were $1.49 billion or 4.4% of total revenue.
AstraZeneca is currently suing the FDA after it denied the firm’s request that the regulator withhold approving any generic form of its drug, with labelling that excludes warnings required for Seroquel and Seroquel XR.
The firm’s US patent for Seroquel XR expires on 26 March, after the firm was granted an extended paediatric licence.
Ben Adams
Related Content
Sandoz’ Ondibta receives European Commission approval for diabetes
Sandoz has announced that its Ondibta (insulin glargine) has received approval from the European Commission …
Teva’s Ajovy significantly reduces migraine in children and adolescents
Teva’s Ajovy (fremanezumab) has demonstrated significant reduction in monthly migraine and headache days in children …
Teva announces positive results from trial of AJOVY for migraine
Teva has announced positive results from the phase 4 PEARL study of AJOVY (fremanezumab), its …
