BOCA RATON, Fla., July 28 /PRNewswire/ -- Breckenridge announced today that through its agreement with Tris Pharma, the company will market Methylphenidate Solution, the generic version of Methylin® marketed by Shionogi Pharma, Inc., under an Abbreviated New Drug Application (ANDA). Under the terms of this agreement, the products will be manufactured by Tris Pharma, and marketed and distributed by Breckenridge on an exclusive basis in the U.S. The companies plan to start shipping immediately. Methylphenidate Oral Solution was filed with a Paragraph IV Certification under Hatch-Waxman and, having "first-to-file status," the companies will enjoy a 180-Day generic exclusivity period granted under the statute. Separately the two companies also have an agreement to market several additional ANDA liquids upon approval by the FDA.
Breckenridge Pharmaceutical is a privately held pharmaceutical marketing, research and development company founded in 1983 that markets a broad range of Generic prescription products in many therapeutic categories; including several unique ValuBrand™ products. The Breckenridge label is recognized by Wholesalers, Distributors, Chains, and Managed Care Accounts, as well as Retail Pharmacies nationwide. The company markets over 100 products, including multiple ANDA's, in a variety of dosage forms including: Tablets, Capsules, Soft Gel Capsules, Liquids, Suspensions and Topical preparations. Breckenridge was recently honored as a 50th Anniversary DIANA award winner for "Best Overall Generic Products Manufacturer" by the HDMA in October 2009.
About Tris Pharma:
Tris Pharma is a privately owned, product-focused, specialty pharmaceutical company engaged in the research and development of innovative drug delivery technologies. Through its OralXR+ platform, Tris has pioneered the delivery of sustained release technology in the liquid, chewable/ODT and strip dosage forms so patients do not have to swallow a pill. Tris' NoBuse™ platform provides abuse-deterrence for opioids and other abuse-prone drugs. The company has more than 20 Rx and OTC products in development with pharmaceutical partners. Tris' R&D and manufacturing facilities are located in Monmouth Junction, New Jersey.
Methylin is a registered trademark of Mallinckrodt Inc.
SOURCE Breckenridge Pharmaceutical, Inc.