BOCA RATON, Fla., Oct. 3, 2012 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today that it has entered into an agreement with Ajanta Pharma, Ltd. to market its Abbreviated New Drug Application (ANDA) for Risperidone Tablets, the generic version of Risperdal® Tablets by Janssen Pharma. The product was approved by the U.S. Food and Drug Administration (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 U.S. 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 5-16 years.
The current generic market is approximately $20M, based on industry sales data. The product is available in 6 strengths: 0.25mg, 0.5mg, 1mg, 2mg, 3mg, & 4mg.
About Breckenridge Pharmaceutical, Inc.
Breckenridge 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.
Ajanta Pharma is a specialty pharmaceutical company engaged in the development, manufacture and commercialization of pharmaceutical products, headquartered in Mumbai, India. The company employs over 3,200 people worldwide and their products are sold in over 30 countries. Ajanta operates with 5 state-of-the art manufacturing facilities that produce high quality pharmaceutical products. They focus on commercializing unique generic products and pioneering synergistic combination products in the therapeutic areas of anti- malarial, cardiology, dermatology, gastroenterology, musculoskeletal, ophthalmology and respiratory.
SOURCE Breckenridge Pharmaceutical, Inc.