Teva Pursues Shire's Adderall, Wins EU Azilect Approval

Israeli generics major Teva has submitted an application to make a generic version of Adderall XR, the attention deficit hyperactivity disorder drug manufactured by UK drugmaker Shire Pharmaceutical.

The drug has recently been the subject of controversy in Canada, where regulators ordered its withdrawal despite the US FDA's decision only to order a re-labelling. Adderall, described as mixed salts of a single-entity amphetamine product, currently accounts for roughly half Shire's annual revenue of US$345mn. The British drugmaker has previously had to defend the drug's two patents, which are not due to expire until 2018, against attempts by Barr Laboratories, Impax Laboratories and Colony Pharmaceuticals to make a generic version.

Meanwhile, Teva and Danish drugmaker Lundbeck A/S have announced that their Azilect (rasagiline) treatment has received a EU marketing licence. The drug, a novel monoamine oxidase-B inhibitor indicated for Parkinson's Disease, has been developed under a long-term strategic alliance between the two companies. The drug was originally discovered under a partnership between Teva and the Israel Institute of Technology. Marketing is to begin in the second quarter, with Teva estimating the European Parkinson's market at some US$900mn per year.