Teva among first cleared to launch Abilify generic

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WASHINGTON — The Food and Drug Administration has approved the first generic versions of Otsuka Pharmaceutical’s Abilify (aripiprazole), an antipsychotic drug.

The FDA said Tuesday that Teva Pharmaceuticals, Alembic Pharmaceuticals, Hetero Labs and Torrent Pharmaceuticals have been cleared to market generic aripiprazole in multiple strengths and dosage forms.

With the approval, Teva Pharmaceutical Industries Ltd. on Tuesday announced the U.S. launch of the generic aripiprazole tablets in dosages of 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg.

Aripiprazole tablet are approved for the treatment of schizophrenia and bipolar disorder, which is also known as manic-depressive illness.

“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,” stated Siggi Olafsson, president and chief executive officer of global generic medicines for Teva.

Teva said it remains engaged in a patent litigation in the U.S. District Court for the District of New Jersey with Otsuka Pharmaceutical Co. Ltd. According to Teva, Otsuka has asserted three patents and recently requested a temporary restraining order (TRO) based on one of those patents, a combination patent, to block generic competition beyond the April 20, 2015, expiration of pediatric exclusivity on its compound patent. On April 16, the District Court denied Otsuka’s request for a TRO based on the combination patent, Teva reported.

Abilify tablets, marketed by Otsuka, had annual U.S. sales of about $7.8 billion through December 2014, according to IMS Health data cited by Teva.


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