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Event – Abilify Depot long-acting in more ways than one

Date January 28, 2013

Of the seven blockbusters due to come off patent in 2015, the current biggest seller is Abilify. Otsuka’s antipsychotic, far and away the company’s most lucrative product, raked in $5.2bn worldwide in 2011 and the company will feel its loss keenly. Otsuka’s long-acting formulation, Abilify Depot, will mitigate this loss to a degree, but only if it is approved by the FDA next month.

The approval is even more crucial to the drug’s licensee, Lundbeck. The Danish group paid $200m up front for worldwide co-marketing rights, and needs the FDA to wave Abilify Depot through to help validate its strategy of focusing on CNS disorders. The FDA rejected an approval application in July, meaning that the partners have already lost eight months of market time. With competition in the form of Alkermes’ ALKS 9070 approaching fast, another delay to Abilify Depot would be a bad blow.

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