Barr Receives Tentative Approval for Modafinil Tablets, 100 mg and 200 mg
Thursday, January 8, 2004 10:43 AM ET Printer-friendly version
WOODCLIFF LAKE, N.J., Jan. 8 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE: BRL, news) today announced that its wholly-owned subsidiary, Barr Laboratories, Inc., has received tentative approval from the U.S. Food and Drug Administration (FDA) for its generic version of Cephalon's Provigil® Tablets (Modafinil Tablets), 100 mg and 200 mg. The Company is currently litigating whether its products infringe a patent held by Cephalon. A trial in the U.S. District Court of New Jersey is currently scheduled for January 2005.
Barr's tentatively approved Modafinil Tablets is indicated to improve wakefulness in patients with excessive daytime sleepiness associated with narcolepsy. Modafinil Tablets had annual sales of approximately $289 million, based on IMS data for the twelve months ended November 2003.
Barr filed an Abbreviated New Drug Application (ANDA) for Modafinil Tablets, 100 mg and 200 mg, with the FDA on December 24, 2002, and received notification of the application's acceptance for filing in early February 2003. Following receipt of notice from FDA, Barr notified Cephalon on February 20, 2003 of Barr's challenge to the two patents that Cephalon had listed in the Orange Book in connection with Provigil®. On March 28, 2003, Cephalon filed suit against four generic pharmaceutical companies, including Barr, for alleged infringement of one of two listed Cephalon patents in U.S. District Court for the District of New Jersey.
A tentative approval reflects FDA's preliminary determination that a generic product satisfies the substantive requirements for approval, subject to the expiration of all statutorily imposed non-approval periods. A tentative approval does not allow the applicant to market the generic drug product.
Barr Pharmaceuticals, Inc. and its subsidiaries are engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals.
Forward-Looking Statements
The following press release contains a number of forward-looking statements. To the extent that any statements made in this press release contain information that is not historical, these statements are essentially forward-looking. Forward-looking statements can be identified by their use of words such as "expects," "plans," "will," "may," "anticipates," "believes," "should," "intends," "estimates" and other words of similar meaning. These statements are subject to risks and uncertainties that cannot be predicted or quantified and, consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include: the difficulty in predicting the timing and outcome of legal proceedings, including patent-related matters such as patent challenge settlements and patent infringement cases; the difficulty of predicting the timing of U.S. Food and Drug Administration, or FDA, approvals; court and FDA decisions on exclusivity periods; the ability of competitors to extend exclusivity periods for their products; the success of our product development activities; market and customer acceptance and demand for our pharmaceutical products; our dependence on revenues from significant customers; reimbursement policies of third party payors; our dependence on revenues from significant products; the use of estimates in the preparation of our financial statements; the impact of competitive products and pricing; the ability to develop and launch new products on a timely basis; the availability of raw materials; the availability of any product we purchase and sell as a distributor; our mix of product sales between manufactured products, which typically have higher margins, and distributed products; the regulatory environment; our exposure to product liability and other lawsuits and contingencies; the increasing cost of insurance and the availability of product liability insurance coverage; our timely and successful completion of strategic initiatives, including integrating companies and products we acquire and implementing new enterprise resource planning systems; fluctuations in operating results, including the effects on such results from spending for research and development, sales and marketing activities and patent challenge activities; and other risks detailed from time to time in our filings with the Securities and Exchange Commission.
Source: Barr Pharmaceuticals, Inc.
Contact: Carol A. Cox of Barr Pharmaceuticals, Inc., +1-201-930-3720, ccox@barrlabs.com |
