Otsuka loses lawsuit challenging FDA approval of generic Abilify

(Reuters) - Otsuka Pharmaceutical Co Ltd has lost a lawsuit challenging the U.S. Food and Drug Administration’s decision to allow generic versions of the company’s antipsychotic drug Abilify.

At the end of April, the FDA approved applications to make Abilify by several generic drugmakers, including Teva Pharmaceutical Industries Ltd, which immediately announced it would launch its own version.

Otsuka sued the FDA saying it had an exclusive right to make Abilify until 2021 because the drug was designated an “orphan drug,” one that treats a rare condition, when it was approved for pediatric Tourette’s syndrome.

U.S. District Judge George Hazel denied Otsuka’s motion for a preliminary order blocking generic Abilify the day after the FDA approved it, and issued a final ruling against Otsuka on Wednesday.

The FDA gives several years of exclusivity to orphan drugs in order to encourage companies to work on them since they might otherwise not be profitable given their high costs to develop.

Hazel said Abilify has non-pediatric uses, which are not protected by orphan-drug status, allowing generic versions to go ahead. The drug is approved to treat schizophrenia and bipolar disorder, and lost patent protection for those uses in April.

Otsuka may still appeal. A spokesman said the was reviewing Wednesday’s decision and considering its options.

Abilify, which is sold by Bristol-Myers Squibb Co in the United States, brought in sales of $554 million in the first quarter.

Reporting By Brendan Pierson in New York; Editing by Ted Botha and Alan Crosby