Federal Judge: FDA Authorized in Approving Generic Abilify
A federal judge has ruled that the FDA was right in approving generic versions of Otsuka’s blockbuster antipsychotic Abilify, despite exclusivity remaining on at least one indication, removing any final obstacles to market entry of those drugs.
The FDA gave its blessing April 28 to generic Abilify (aripiprazole) manufactured by Alembic Pharmaceuticals, Hetero Labs, Teva and Torrent Pharmaceuticals, despite strong objections from Otsuka that led to an expedited lawsuit against the agency.
The brandmaker accused the FDA of knowingly eliminating its monopoly protection by extending Abilify’s pediatric indication for Tourette syndrome to adults, which Otsuka 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 to 2021.
In approving generic versions of Abilify last week, the FDA said a labeling carveout would protect Otsuka’s pediatric exclusivity.
In the April 29 ruling in Otsuka Pharmaceutical Co., Ltd. et al. v. Sylvia Matthews Burwell et al., Judge George J. Hazel denied the brandmaker’s request, saying the FD&C Act gives the FDA broad authority to approve ANDAs that carve out exclusivities, including orphan exclusivity.
Teva announced it is ready to launch generic Abilify in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg dosage forms.
Otsuka said that is doesn’t comment on pending litigation. — Jessica Grinspan