Game on: FDA approves first generics of blockbuster antipsychotic Abilify
- Generic aripiprazole (Bristol-Myers Squibb's Abilify), which is used to treat schizophrenia and bipolar disorder (BPD), will be be available in multiple strengths and dosages.
- Four manufacturers have received approval to market generic aripiprazole, including Alembic Pharmaceuticals, Hetero Labs, Teva, and Torrent Pharmaceuticals.
- As an atypical antipsychotic, aripiprazole carries a boxed warning regarding an increased risk of suicidal thinking in children, adolescents and young adults.
With more than $7.5 billion in sales in the U.S., Abilify, co-marketed by BMS and Otsuka, is easily one of the top-selling drugs in the nation. Since it was originally approved in 2003, it has racked up one approval after another, including approvals for schizophrenia and BPD in various populations.
All told, between schizophrenia, which affects 1% of the population, and BPD, which affects roughly 1.5% of the population, aripiprazole represents an important treatment options for 2.5% of the population—and now they have a generic option.