FDA Approves Generic Version of Abilify

The US Food and Drug Administration (FDA) has approved the first generic versions of Abilify (aripiprazole). Generic aripiprazole is an atypical antipsychotic drug approved to treat schizophrenia and bipolar disorder. Alembic Pharmaceuticals Ltd., Hetero Labs Ltd., Teva Pharmaceuticals and Torrent Pharmaceuticals Ltd. have received FDA approval to market generic aripiprazole in multiple strengths and dosage forms.

Teva Pharmaceutical Industries has launched the generic equivalent to Abilify (aripiprazole) tablets, 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg, in the United States. 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.

Teva remains involved in a patent litigation in the US District Court for the District of New Jersey in which Otsuka Pharmaceutical Co., Ltd. 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 April 20, 2015 expiration of pediatric exclusivity on Otsuka's compound patent. On April 16, 2015, the District Court denied Otsuka's request for a TRO based on the combination patent, according to information from Teva.

Abilify, marketed by Otsuka Pharmaceutical, had annual sales of approximately $7.8 billion in the United States, according to IMS data as of December 2014, and as reported by Teva.

Bristol-Myers Squibb has a worldwide commercialization agreement with Otsuka to co-develop and co-promote Abilify, excluding certain Asian countries. The US portion of the agreement was amended in 2009 and 2012 and was scheduled to expire upon the expected loss of product exclusivity on April 20, 2015, according to the company’s annual filing. The agreement expired in all European Union countries in June 2014, and in each other non-U.S. countr where BMS has the exclusive right to sell Abilify, the agreement expires on the later of April 20, 2015 or loss of exclusivity in any such country.

Source: Teva and FDA

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