Ostuka’s Abilify Patent under Generic Threat

Barr Pharmaceuticals has made a Para IV challenged against Japanese drugmaker Otsuka Pharmaceutical over atypical antipsychotic drug Abilify, generically known as Aripiprazole worth US $ 1.9 billion annual sales (based on IMS sales data ending January 2007). In response to Barr Para IV challenge, Otsuka has filed a patent infringement lawsuit in the U.S. District Court for the District of New Jersey. Abilify is used in the treatment of schizophrenia and the manic and mixed episodes associated with bipolar disorder and currently been licensed to Bristol-Myers Squibb Co. which got US approval in 2002. Para IV certification would likely give Barr 180 days of exclusive marketing rights.