Generic Equivalent to Novartis' Trileptal(R) Tablets, 150 mg, 300 mg and 600 mg
HAWTHORNE, N.Y., Jan 09, 2008 (BUSINESS WIRE) -- Taro Pharmaceutical Industries Ltd. ("Taro," Pink Sheets: TAROF) reported today that it settled a pending lawsuit with Novartis and will be launching Oxcarbazepine Tablets 150 mg, 300 mg, and 600 mg ("Oxcarbazepine Tablets") in the United States.
Oxcarbazepine Tablets, marketed by Novartis as Trileptal(R) Tablets, is a prescription pharmaceutical product used in treating seizures. Taro recently settled litigation with Novartis regarding Taro's "Paragraph IV" certification challenging Novartis' patent protection on Trileptal(R). On November 15, 2007, Taro received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Oxcarbazepine Tablets 150 mg, 300 mg, and 600 mg. The Company did not immediately launch the product at that time, pending settlement of the litigation with Novartis. The Company plans to launch Oxcarbazepine Tablets in the near future. According to industry sources, Trileptal(R) Tablets currently have annual U.S. sales of approximately $700 million.
Taro Pharmaceutical Industries Ltd. is a multinational, science-based pharmaceutical company, dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products.
For further information on Taro Pharmaceutical Industries Ltd., please visit the Company's website at www.taro.com.
Certain statements in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company's new oxcarbazepine product. Although Taro Pharmaceutical Industries Ltd. believes the expectations reflected in such forward-looking statements to be based on reasonable assumptions, it can give no assurance that its expectations will be attained. Factors that could cause actual results to differ include industry and market conditions; slower than anticipated penetration of new markets; marketplace acceptance of the new Taro product; changes in the Company's financial position; regulatory actions; and, other risks detailed from time to time in the Company's SEC reports, including its Annual Reports on Form 20-F. Forward-looking statements speak only as of the date on which they are made. The Company undertakes no obligation to update, change or revise any forward-looking statements, whether as a result of new information, additional or subsequent developments or otherwise.
SOURCE: Taro Pharmaceutical Industries Ltd.
Kekst and Company
Roanne Kulakoff, 212-521-4837