Ajanta Pharma, a Rs.650 crore plus Mumbai based pharma major, has entered an agreement with Breckenridge Pharmaceutical, Inc. to market Risperidone tablets, the generic version of Risperdal tablets by Janssen Pharma. The product was approved by the US FDA on August 24, 2011. Under the terms of this agreement, Ajanta Pharma will manufacture and supply the product to Breckenridge Pharmaceutical, Inc., who will have exclusive marketing and distribution rights in the US. The companies will start shipping immediately.
Risperidone tablets are an atypical antipsychotic agent indicated for the treatment of schizophrenia in adults and adolescent aged 13-17 years 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, and alone in children and adolescent aged 10-17 years, and also for the treatment of irritability associated with autistic disorder in children and adolescents aged five to 16 years.
The current generic market is approximately $20 million, based on industry sales data. The product is available in six strengths: 0.25mg, 0.5mg, one mg, two mg, three mg, and four mg.
Breckenridge Pharmaceutical Inc., is a privately-held pharmaceutical marketing, research and development company founded in 1983 that markets a broad range of generic prescription products and medical foods in many therapeutic categories. The Breckenridge label is recognized by wholesalers, distributors, chains, and managed care accounts, as well as retail pharmacies nationwide. The company markets over 60 products in a variety of dosage forms including tablets, capsules, soft gel capsules, and liquids, and powders.
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