Par Pharmaceutical Companies, Inc has started shipping 0.25 mg, 3 mg and 4 mg strengths of risperidone ODT to the trade. Risperidone ODT is a generic version of Janssen Pharma's Risperdal M-TAB.
Annual US sales of Risperdal M-TAB were approximately $89 million in 2008, according to IMS Health data. Par has been awarded 180 days of marketing exclusivity for being the first to file an ANDA containing a paragraph IV certification for these three strengths of the product.
Risperidone is an atypical antipsychotic agent indicated for the acute and maintenance treatment of schizophrenia in adults and alone, or in combination with lithium or valproate, for the short-term treatment of acute manic or mixed episodes associated with Bipolar I Disorder in adults.
Par Pharmaceutical develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets.