FDA Fights Otsuka Motion to Block Generic Abilify

As Otsuka’s exclusivity protection for its blockbuster Tourette syndrome drug Abilify expired last week, the FDA urged a federal judge not to grant the drugmaker’s last-ditch request for a court order blocking the agency from approving generic versions of the drug.

In a court filing last week in Otsuka Pharmaceutical Co., Ltd. v. Sylvia Mathews Burwell et al., the FDA claims that Otsuka failed to prove it will suffer “certain, great, and irreparable injury” in the absence of a restraining order or injunction and that the drugmaker’s attempts to delay generic competition on Abilify (aripriprazole) do not outweigh the public interest in having access to affordable drugs.

This was Otsuka’s latest effort to prevent generic forms of Abilify from reaching the market. The drugmaker claims the FDA stripped the drug of its orphan treatment status by modifying its indication to include all Tourette patients — not just children, as Otsuka had sought. Otsuka charged that this unsolicited change was a direct violation of the Orphan Drug Law, because orphan exclusivity bars all generics on a drug’s approved indications.

The Maryland district court judge has yet to rule on either request.

Both Otsuka and the FDA declined to comment on the matter. — Jessica Grinspan