- Approvals for generic versions of Abilify (aripiprazole) are slated to start in May, but Otsuka and its partner Bristol-Myers Squibb are fighting back.
- Abilify grossed $5.5 billion in revenues last year, however, BMS is already factoring in losses due to genericization.
- Otsuka continues to fight in Maryland federal court.
Although the patent for use of Abilify (aripiprazole) for psychiatric uses is due to expire later this spring, Otsuka is claiming that it has the right to block generic entry into the market based on a seven-year exclusivity deal associated with it pediatric indication in Tourette's disorder.
Arguably, it would be difficult to prevent physicians from prescribing generic Abilify for a specific purpose, so Otsuka has a point, but it seems like a technicality. By summer 2015, it will become clear whether generic versions will be blocked.