Breckenridge Pharmaceutical Settles 'Paragraph IV' Litigation and Receives FDA Approval for its Oxcarbazepine ANDA
BOCA RATON, Fla., Jan. 11 /PRNewswire-FirstCall/ -- Breckenridge Pharmaceutical, Inc. announced today that it settled "Paragraph IV" litigation with Novartis concerning Trileptal(R) and that the U.S. Food and Drug Administration approved Breckenridge's Abbreviated New Drug Application for oxcarbazepine 150mg, 300mg and 600 mg tablets in the United States ("Oxcarbazepine Tablets"). Breckenridge enjoys a shared 180-day exclusivity period and will immediately launch Oxcarbazepine Tablets 150 mg, 300 mg, and 600 mg. Oxcarbazepine Tablets are AB rated to Trileptal(R), a $600 million brand name drug marketed by Novartis Pharmaceuticals Corporation, and are used in treating seizures. Breckenridge is actively seeking development and marketing alliances with domestic and foreign companies for generic and branded pharmaceuticals. Breckenridge products are contract manufactured through partnerships with pharmaceutical manufacturers in state-of-the-art facilities throughout the U.S. Breckenridge maintains a stringent Quality Assurance program to ensure a consistent supply of quality pharmaceutical products. About Breckenridge: Breckenridge Pharmaceutical, Inc., a privately-held pharmaceutical marketing research and development company founded in 1983, is headquartered in Boca Raton, FL, with offices in Berlin, CT, and Fairfield, NJ. Breckenridge markets over 100 products in many therapeutic categories to over 100 customers in all classes of trade. Trileptal(R) is a registered trademark of Novartis Pharmaceuticals Corporation
SOURCE Breckenridge Pharmaceutical, Inc.
More by this Source
Breckenridge Completes Acquisition of Certain Cypress Products from Pernix Therapeutics
Sep 11, 2013, 17:13 ET
Browse our custom packages or build your own to meet your unique communications needs.
Learn about PR Newswire services
Request more information about PR Newswire products and services or call us at (888) 776-0942.