Barr gets US OK for generic Adderall

Barr Laboratories has been granted approval by the US Food and DrugAdministration to market a generic version of Adderall (mixed amphetamine salts), a drug for attention-deficit hyperactivity disorder sold by Shire Pharmaceuticals of the UK's local subsidiary, Shire Richwood, in the USA. Sales of the branded form in the USA were around $345 million last year.

Barr said that it is planning an immediate launch of its generic, which consists of a mixture of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate, and also expects to be the first to offer such a product. Last month, the company was granted approval to market a generic form of another ADHD treatment, Dexedrine Spansules (dextroamphetamine; brand marketed by GlaxoSmithKline), and sees the category as an important growth driver for the future (Marketletter January 28).

The launch, which comes a little earlier than expected, is a blow to Shire, given that Adderall makes up around a third of the company's revenues. The company had been hoping for more time to switch patients on Adderall to its new once-daily version, Adderall XR, which was launched in the USA last year (Marketletter November 5). Some analysts have said that almost a third of patients who were taking Adderall have already switched to the new form.