Johnson & Johnson won federal approval Wednesday for a schizophrenia drug derived from another top-selling anti-psychotic medicine.
The Food and Drug Administration said Invega will add to the treatment options for the disabling mental disorder, which affects about 2 million Americans.
It also could add to the bottom line for J&J, which faces the loss of patent protection in December 2007 for the No. 3 anti-psychotic drug, Risperdal. Risperdal, also called risperidone, had $2.3 billion in sales in 2005, according to the pharmaceutical data company IMS Health.
Confronted with the prospect of competition from generic versions of the drug, the New Brunswick, N.J.-based company seeks a further six months’ patent protection for Risperdal by studying its use in children.
Invega, also called paliperidone, is derived from Risperdal. The body breaks down Risperdal to form paliperidone.
Unlike Risperdal, Invega will be sold in extended-release tablet form. The company didn’t disclose the drug’s cost, saying only that it would be priced competitively with other anti-psychotics.
Schizophrenia is marked by hallucinations, delusions, disordered thinking and movements and cognitive deficits, the FDA said.
