Breckenridge Pharmaceutical Settles 'Paragraph IV' Litigation and Receives FDA Approval for its Oxcarbazepine ANDA

Jan 11, 2008, 00:00 ET from Breckenridge Pharmaceutical, Inc.

    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
     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

SOURCE Breckenridge Pharmaceutical, Inc.