FDA's tentative OK for generic Depakote

The US Food and Drug Administration has granted Apotex a tentativeapproval for 125mg, 250mg and 500mg divalproex sodium delayed-release tablets for the treatment of epilepsy.

Divalproex sodium is currently marketed in the USA by Abbott Laboratories under the brand name Depakote, and is the company's best-selling product, with sales last year increasing 7.5% to $744.5 million. Apotex and Abbott are currently involved in litigation over two of the latter's patents, that Abbott maintains would be infringed by the former's proposed divalproex sodium product. Apotex is appealing the decision of the federal District Court in Chicago, USA, which ruled in Abbott's favor in March of this year, asking it to reconsider its judgement. If this effort is successful, Apotex will aim to bring its generic to market within the next year.

Apotex's generic version is their second to gain a tentative approval from the FDA this month, the first being a generic version of GlaxoSmithKline's antidepressant Paxil (paroxetine). However, the generics firm is being prevented from marketing its version because GSK has filed for several additional patents relating to Paxil (Marketletters passim).