FDA Approves First Generics of Antipsychotic Abilify

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FDA Approves First Generics of Antipsychotic Abilify
FDA Approves First Generics of Antipsychotic Abilify

The FDA on Tuesday approved the first generics of the blockbuster atypical antipsychotic aripiprazole (Abilify), dealing a major blow to Otsuka Pharmacutical and Bristol-Myers Squibb, which market the drug.

Four generic manufacturers, Alembic Pharmaceuticals, Hetero Labs, Teva Pharmaceuticals, and Torrent Pharmaceuticals received approval in multiple strengths.

Aripiprazole is approved to treat schizophrenia and bipolar disorder, as well as irriitability associated with autism and Tourette's syndrome.

Teva is wasting no time shipping the drug, saying it has launched aripiprazole in six dosage strengths. However, Teva conceded that it is still embroiled in patent litigation with several Abilify patents. But a federal court recently rejected a temporary restraining order to block the generic launch requested by Otsuka over one of the patents.

Annual sales of Abilify were $7.8 billion as of December 2014, according to IMS data.

Otsuka has been preparing for the loss of patent exclusivity on its best-selling drug. Earlier this month, the drugmaker released positive Phase III data on brexipiprazole, its follow-on to aripiprazole. The FDA is slated to make a decision on that drug's NDA in July.


U.S. Food and Drug Administration. FDA approves first generic Abilify to treat mental illnesses. News Release. April 28, 2015.

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