Court ruling allows Barr, Teva to market generic allergy medication

By Lisa Kerner

Erie, Pa., Jan. 27 - Barr Pharmaceuticals, Inc. and Teva Pharmaceutical Industries Ltd. can continue to market Fexofenadine Hydrochloride (30 mg, 60 mg and 180 mg Tablets), the generic versions of Aventis' Allegra Tablets for allergies.

The U.S. District Court for the District of New Jersey denied a motion filed by Aventis Pharmaceuticals, Inc. and Albany Molecular Research, Inc. to stop Barr and Teva from marketing the products, according to a company news release.

In June 2004 Barr and Teva were granted summary judgment of non-infringement with respect to three patents and were granted summary judgment of invalidity on an additional patent in the case in April 2005.

Several patents remain in the litigation. While no trial date has been set, the companies expect a trial will occur this year.

"Since our September launch, consumers have realized considerable savings as a result of the competition our product has created," Barr chairman and chief executive officer Bruce L. Downey said in the release. "We will continue to defend our launch of this product as we pursue the underlying patent challenge litigation with Aventis."

Barr and Teva formed an agreement to launch the Fexofenadine Hydrochloride Tablet products.

Under terms of the agreement, Barr was responsible for the regulatory steps to obtain final Food and Drug Administration approval of Teva's Fexofenadine Hydrochloride Tablets, the company said.

Barr was the first generic applicant to file an abbreviated New Drug Application challenging the patents related to the Allegra tablet products. As a result, Barr was granted 180 days exclusivity, which has since been transferred to Teva.

Barr Pharmaceuticals is a holding company whose principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., develop, manufacture and market generic and proprietary pharmaceuticals. The company is based in Woodcliff Lake, N.J.

Teva Pharmaceutical Industries, based in Jerusalem, Israel, develops, manufactures and markets generic and innovative pharmaceuticals and active pharmaceutical ingredients.

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