BOCA RATON, Fla., March 26, 2013 /PRNewswire/ -- Breckenridge Pharmaceutical, Inc. announced today that it has entered into an agreement with Aptalis Pharmatech, Inc. to market Propranolol Hydrochloride Extended-Release Capsules, USP the generic version of Inderal® LA by Akrimax Pharmaceuticals, LLC, under Aptalis Pharmatech, Inc.'s Abbreviated New Drug Application (ANDA). The product was approved by the U.S. Food and Drug Administration (FDA) on July 15, 2011. Under the terms of this agreement, Aptalis Pharmatech, Inc. will manufacture and supply the product to Breckenridge Pharmaceutical, Inc., who will have exclusive marketing and distribution rights in the U.S. The companies have already begun shipping the product.
Propranolol Hydrochloride Extended-Release Capsules are indicated to treat hypertension, angina pectoris due to coronary atherosclerosis, migraine, and hypertrophic subaortic stenosis.
The current generic market is approximately $75 million USD, based on industry sales data. The product is available in 4 strengths: 60mg, 80mg, 120mg and 160mg.
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.
Aptalis Pharma™ is a privately held, leading specialty pharmaceutical company providing innovative, effective therapies for unmet medical needs including cystic fibrosis and gastrointestinal disorders. Aptalis has manufacturing and commercial operations in the United States, the European Union and Canada, and its products include ZENPEP®, CANASA®, CARAFATE®, PYLERA®, RECTIV®, VIOKACE™, ULTRESA, LACTEOL®, DELURSAN®, PANZYTRAT®, and SALOFALK®. Aptalis also formulates and clinically develops enhanced pharmaceutical and biopharmaceutical products for itself and others using its proprietary technology platforms including bioavailability enhancement of poorly soluble drugs, custom release profiles, and taste-masking/orally disintegrating tablet (ODT) formulations. For more information, visit www.aptalispharma.com.
SOURCE Breckenridge Pharmaceutical, Inc.