Otsuka Fails to Protect Abilify Franchise, Court Sides With FDA on Generic Approvals

In a blow to Japanese drugmaker Otsuka Pharmaceutical Co., a federal court May 27 said that the Food and Drug Administration’s decision to approve generic versions of Otsuka’s Abilify (aripiprazole) was lawful, allowing generic versions of the blockbuster antipsychotic to enter the market (Otsuka Pharm. Co. v. Burwell, 2015 BL 166469, D. Md., 8:15-cv-00852-GJH, 5/27/15).

The U.S. District Court for the District of Maryland granted summary judgment to the FDA and the generic company defendant-intervenors. Judge George J. Hazel said that the agency acted within its authority when it approved generic versions of the drug that carved ...