- Since Abilify (aripiprazole) lost patent protection in April, Otsuka has been claiming that the patent does not expire until 2021.
- The company just lost a lawsuit challenging the FDA's decision to allow generic versions of Abilfy into the market.
- Teva's generic version of Abilify was approved by the FDA at the end of April.
Otsuka's argument did not hold up in court in terms of the idea that Abilify should retain patent protection through 2021. Although Abilify's approval for use in patients with schizophrenia dates back more than 12 years, in December 2014, Otsuka/BMS received an approval for use of Abilify in treating Tourette's syndrome in children. And because Tourette's is an orphan disease, the thinking is that Abilify should enjoy the requisite seven-year patent protection period afforded orphan drugs. However, the judge made the case that Abilify's non-pediatric uses are not protected by orphan-drug status.
Although Otsuka has the right to appeal, at this point, Teva can launch its generic version of Abilify into the marketplace.