FDA Approves First Generic Abilify to Treat Mental Illnesses

Teva Pharmaceutical Industries has announced the launch of the generic equivalent to Abilify (aripiprazole) Tablets, 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg, in the US. Aripiprazole tablets, an atypical antipsychotic medication, are approved for the treatment of schizophrenia and for the acute treatment of manic and mixed episodes associated with bipolar I disorder.

“Our commitment at Teva is to make affordable, high-quality generic medicines available to millions of patients every day. We are pleased to launch generic Aripiprazole tablets and offer a generic treatment for patients suffering from schizophrenia and bipolar I disorder,” said Siggi Olafsson, President and CEO, Global Generic Medicines for Teva.

Teva remains involved in a patent litigation in the US District Court for the District of New Jersey in which Otsuka Pharmaceutical has asserted three patents, and recently requested a temporary restraining order (TRO) based solely on one of those patents, a combination patent, to block generic competition beyond the 20 April 2015 expiration of pediatric exclusivity on Otsuka’s compound patent. On 16 April 2015, the District Court denied Otsuka’s request for a TRO based on the combination patent, finding that Otsuka’s likelihood of success on the merits is low.

Abilify (aripiprazole) Tablets, marketed by Otsuka Pharmaceutical, had annual sales of approximately $7.8 billion in the US, according to IMS data as of December 2014.