WOODCLIFF LAKE, N.J., April 1 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that the U.S. District Court in New Jersey has granted summary judgment of invalidity on an additional patent in Barr Laboratories, Inc.'s ("Barr"), patent challenge litigation involving Allegra(R) (Fexofenadine Hydrochloride) allergy treatment products. The court had previously granted summary judgment of non-infringement with respect to three other patents in the case.
The court has yet to rule on six patents remaining in the litigation -- three method-of-use patents, two raw material patents and a formulation patent that has been asserted only against the generic version of Allegra-D(R). While no trial date has been set, Barr anticipates that the case may be ready for trial later this year.
"We are very pleased that the Judge has removed an additional obstacle in our Allegra patent challenge, as we continue our progress toward a trial," said Bruce L. Downey, Barr Pharmaceutical's Chairman and CEO. "We remain committed to bringing this litigation to a successful conclusion for Barr and the millions of allergy sufferers who take Allegra," Downey continued.
Barr filed an Abbreviated New Drug Application (ANDA) for Fexofenadine HCI 60 mg capsules in May 2001, an ANDA for Fexofenadine HCI 30 mg, 60 mg, and 180 mg tablets in June 2001, and an ANDA for Fexofenadine Hydrochloride 60 mg and Pseudoephedrine Hydrochloride 120 mg Extended-Release Tablets (marketed by Aventis as Allegra-D) in September 2001. The Company believes it was the first applicant to file an ANDA containing a paragraph IV patent challenge with respect to the capsule and tablet products and that Barr was the first to file on all but one of the patents relating to the Allegra-D product. Barr recently filed an action against FDA asserting that Barr is entitled to 180 days of generic exclusivity on the Allegra D product.
Aventis filed suits in 2001 in the United States District Court for the District of New Jersey seeking to prevent approval of Barr's ANDAs until after the expiration of various patents, the last of which expires in 2018. Aventis and AMR Technology, Inc. filed an additional suit against Barr's products in March of 2004.
Allegra(R) is indicated for the relief of symptoms associated with seasonal allergic rhinitis and for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older. Allegra-D(R) is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older. For the 12 months ending January 2005, Allegra tablets had sales of approximately $1.5 billion, while Allegra-D had annual sales of approximately $432 million, based on IMS sales data.
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.
Except for the historical information contained herein, the statements made in this press release constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements can be identified by their use of words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates" and other words of similar meaning. Because such statements inherently involve risks and uncertainties that cannot be predicted or quantified, actual results may differ materially from those expressed or implied by such forward-looking statements depending upon a number of factors affecting the Company's business. These factors include, among others: 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 outcome of litigation arising from challenging the validity or non- infringement of patents covering our products; the difficulty of predicting the timing of FDA approvals; court and FDA decisions on exclusivity periods; the ability of competitors to extend exclusivity periods for their products; our ability to complete product development activities in the timeframes and for the costs we expect; 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 on products, including the launch of authorized generics; the ability to launch new products in the timeframes we expect; the availability of raw materials; the availability of any product we purchase and sell as a distributor; 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 our new enterprise resource planning system; fluctuations in operating results, including the effects on such results from spending for research and development, sales and marketing activities and patent challenge activities; the inherent uncertainty associated with financial projections; changes in generally accepted accounting principles; and other risks detailed from time-to-time in our filings with the Securities and Exchange Commission, including in our Annual Report on Form 10-K for the fiscal year ended June 30, 2004.
The forward-looking statements contained in this press release speak only as of the date the statement was made. The Company undertakes no obligation (nor does it intend) to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required under applicable law.
Barr Pharmaceuticals, Inc.