Otsuka Falters Against FDA Over Abilify Generics

A federal judge dealt Otsuka a blow, dismissing claims that the FDA is precluded from approving generic versions of its blockbuster antipsychotic Abilify until its orphan exclusivity runs out in December 2021.

Judge George Hazel of the U.S. District Court for the Southern District of Maryland ruled last week that the FD&C Act and the FDA’s regulations allow the agency to carve out an indication that is protected by orphan exclusivity as long as the ANDA remains safe and effective for the remaining nonprotected conditions of use.

The ruling grants the FDA’s motion for summary judgment and denies a similar motion by Otsuka.

On April 28, the agency approved generic versions of Abilify (aripiprazole) manufactured by Alembic Pharmaceuticals, Hetero Labs, Teva and Torrent Pharmaceuticals. The following day, Hazel denied the brandmaker’s request for a preliminary injunction or restraining order to bar market entry of the generics.

Otsuka sued the FDA in March, claiming the agency knowingly removed its monopoly protection by extending Abilify’s pediatric indication for Tourette syndrome to adults, which the company had not sought. The FDA’s December 2014 approval of the drug as an orphan treatment specifically for children with Tourette pushed its monopoly protection from April 20 of this year to 2021.

Otsuka could still appeal the decision in Otsuka Pharmaceutical Co., Ltd. et al. v. Sylvia Matthews Burwell et al.

The company did not respond to a request for comment by press time. The FDA does not comment on pending litigation. — Jonathon Shacat