US District Court rejects Otsuka submission to prevent generic competition for Abilify (aripiprazole).- Otsuka

-Otsuka has finally lost its battle with the FDA to prevent generics of its Abilify (aripiprazole) from entering the market. A federal judge issued a final ruling against the company a little more than a month after regulators approved conditionally generic versions of the drug. As Reuters reports, U.S. District Judge George Hazel rejected Otsuka's argument that its 7-year orphan drug exclusivity for Abilify--in pediatric Tourette syndrome--should protect the antipsychotic drug from competition. Abilify's other approved indications are not protected by that orphan-drug status, Hazel pointed out. That means companies such as Alembic Pharmaceuticals, Teva Pharmaceuticals , Hetero Labs and Torrent Pharmaceuticals can proceed with generics.