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Allegra generic to be launched in US

Generic version of rhinitis drug fexofenedine will be soon launched in the US.



13 September,2005: Barr Pharmaceuticals, Inc and Teva Pharmaceutical Industries Ltd have entered into an agreement for the launch of Fexofenadine Hydrochloride 30 mg, 60 mg and 180 mg Tablets.

The pills are the generic equivalent of Aventis Pharmaceuticals’ Allegra tablets. Allegra tablets had annual sales of approximately $1.4 billion, based on IMS data for the twelve months ended June 2005.

Under the agreement, Barr has taken the regulatory steps necessary to permit Teva to obtain final U.S. Food and Drug Administration approval of Teva’s fexofenadine hydrochloride tablets and to sell the product within Barr’s 180-day exclusivity. In return, Barr will receive a negotiated percentage of the gross profit of Teva’s product, both during and after the exclusivity period. Teva will record the revenues resulting from sales of the product and remit the negotiated percentage of its gross profit to Barr. 

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. Although no trial date has been set, the companies expect that a trial will occur sometime in 2006. 

Barr was the first generic applicant to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV patent challenge on the patents related to the Allegra tablet product and consequently was granted 180 days exclusivity, which it has now transferred to Teva. 

Allegra (fexofenadine hydrochloride) 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. 

Barr Pharmaceuticals, Inc is a holding company whose principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., develop, manufacture and market generic and proprietary pharmaceuticals.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. The company develops, manufactures and markets generics and active pharmaceutical ingredients. Close to 90% of Teva’s sales are in North America and Europe.



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