Tentative Approval for a Generic Version of Zofran ODT(R) Orally Disintegrating Tablets

Main Category: Public Health
Article Date: 28 Aug 2004 - 0:00 PDT

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Barr Pharmaceuticals, Inc announced that it has received tentative approval from the FDA for its generic version of GlaxoSmithKline's Zofran ODT(R) (ondansetron) Orally Disintegrating Tablets, 4mg and 8mg. The Company anticipates receiving final approval and launching its generic product following the expiration of GlaxoSmithKline's patent on June 24, 2006 or following any additional applicable exclusivity.

Barr's Ondansetron Orally Disintegrating Tablets are indicated for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy, certain radiotherapies, and the prevention of postoperative nausea and/or vomiting. Zofran ODT had annual sales of approximately $167 million, based on IMS data for the twelve months ended June 2004.

Barr filed an Abbreviated New Drug Application (ANDA) for Ondansetron Orally Disintegrating Tablets, 4mg and 8mg in March 2003, and received notification of the application's acceptance for filing in April 2003. The ANDA contained a paragraph IV certification that two of the patents listed in the Orange Book for Ondansetron Orally Disintegrating Tablets, 4mg and 8mg tablets were invalid or would not be infringed by Barr's product. Following receipt of notice from FDA, Barr notified GlaxoSmithKline of its ANDA filing. GlaxoSmithKline failed to file suit against Barr within the 45-day period provided for by the Hatch-Waxman Act.

Barr's ANDA also contained a paragraph III certification on the three other patents protecting Zofran ODT, the last of which expires on June 24, 2006.

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., a holding company that operates through its principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals.

Forward-Looking Statements

This 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, which typically have lower margins, during any given period; 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.