FDA gives Wockhardt tentative approval for bipolar, schizophrenia drug


PARSIPPANY, N.J. — Indian drug maker Wockhardt has received tentative approval from the Food and Drug Administration for a generic version of a Pfizer psychiatric drug.

Wockhardt announced the tentative approval for ziprasidone hydrochloride in the 20 mg, 40 mg, 60 mg and 80 mg strengths, used to treat bipolar disorder and schizophrenia, and the company plans to launch the drug on Sept. 2, 2012.

The drug is a generic version of Pfizer's Geodon, which has a market size of about $1.3 billion, according to IMS Health. Tentative approval means that the generic drug meets the conditions for FDA approval, but the agency can't approve it because the branded drug's patent has not yet expired. One of Geodon's patents expired in March 2012, and another expires on Sept. 1 of this year, while two more expire in 2018 and 2019, according to FDA records. The drug will lose data exclusivity in November 2012.

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