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| | | | Teva and Barr Announce Launch of Generic Allegra® Tablets by Teva Under Agreement With Barr Sep 11th 2005
Barr Pharmaceuticals, Inc. (NYSE: BRL) and Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced that they have entered into an agreement for the launch of Fexofenadine Hydrochloride 30 mg, 60 mg and 180 mg Tablets... 
the generic versions 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.
“This agreement and launch represent an extraordinary opportunity for consumers and for both companies,” said Bruce L. Downey, Barr’s Chairman and Chief Executive Officer. “However, the courts have yet to resolve the pending patent litigation concerning our generic products. The agreement with Teva enables us to maximize the opportunity, while sharing the risk of the ongoing litigation.”
Israel Makov, Teva’s President and Chief Executive Officer commented, “The launch of Fexofenadine represents the culmination of many months of work between Teva and Barr. It allows us to accelerate the availability of this important generic product and expands the already large portfolio of generic pharmaceutical products that we offer to American consumers.”
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.
Teva Pharmaceutical Industries Ltd. http://www.tevausa.com
Sep 11th 2005
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