DETROIT, Oct. 17 /PRNewswire-FirstCall/ -- Caraco Pharmaceutical Laboratories, Ltd. announced today that it has launched a generic version of Trileptal(R), Oxcarbazepine Tablets (oxcarbazepine), on behalf of Sun Pharmaceutical Industries, Ltd. (Sun Pharma). Sun Pharma recently received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for generic Trileptal(R), and being one of the first-to-file an ANDA with a Paragraph IV certification, shares a 180-day marketing exclusivity. No action for patent infringement has been brought against Sun Pharma.
Oxcarbazepine is indicated for the use in monotherapy or adjunctive therapy for the treatment of partial seizures in adults and as monotherapy in the treatment of partial seizures in children aged 4 years and above with epilepsy, and as adjunctive therapy in children aged 4 years and above with epilepsy. This new product is bioequivalent to Trileptal(R), a registered trademark of Novartis. Trileptal(R) had U.S. sales of approximately $640 million for the 12-month period ended June 30, 2007, according to IMS Data. Caraco has three strengths available, 150 mg, 300 mg and 600 mg.
Daniel H. Movens, Caraco’s Chief Executive Officer, said, “We are pleased to be one of the first companies to market oxcarbazepine. We continue to focus on working towards expanding our product offering as quickly and effectively as possible. This will bring our total product selection to 42 different products represented by 89 various strengths.”
Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures, markets and distributes generic and private-label pharmaceuticals to the nation’s largest wholesalers, distributors, drugstore chains and managed care providers.
Safe Harbor: This news release contains forward-looking statements made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements are based on management’s current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward- looking statements. These risks and uncertainties are contained in the Corporation’s filings with the Securities and Exchange Commission and include, but are not limited to: information of a preliminary nature that may be subject to adjustment, potentially not obtaining or delay in obtaining FDA approval for new products, governmental restrictions on the sale of certain products, development by competitors of new or superior products or cheaper products or new technology for the production of products, the entry into the market of new competitors, market and customer acceptance and demand for new pharmaceutical products, availability of raw materials, timing and success of product development and launches, dependence on few products generating majority of sales, product liability claims for which the Company may be inadequately insured, and other risks identified in this report and from time to time in our periodic reports and registration statements. These forward- looking statements represent our judgment as of the date of this report. We disclaim, however, any intent or obligation to update our forward-looking statements.
CONTACT: Daniel Movens, +1-313-871-8400, or Aaron Miles, +1-313-556-4150,
both for Caraco Pharmaceutical
Web site: http://www.caraco.com/
