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Final Approval Granted for Generic Version of Allegra

WOODCLIFF LAKE, N.J., July 14 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. (NYSE:BRL) today announced that its subsidiary Barr Laboratories, Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its generic version of Aventis Pharmaceuticals' Allegra(R) (Fexofenadine Hydrochloride) Capsules, 60 mg. The Company is the first applicant to file an Abbreviated New Drug Application (ANDA) containing a paragraph IV patent challenge on the patents related to the Allegra capsule product, and is entitled to 180 days of marketing exclusivity on the product.

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. Allegra (Fexofenadine Hydrochloride) Capsules, 60 mg, which had annual sales of approximately $14,000 based on IMS data for the twelve months ended May 2005, is no longer marketed by Aventis.

Barr filed an ANDA for Fexofenadine Hydrochloride Capsules, 60 mg, in May 2001. Following receipt of notice of acceptance from FDA, Barr notified Aventis of its ANDA filing. Aventis filed suit in the United States District Court for the District of New Jersey seeking to prevent approval of Barr's ANDA until after the expiration of various patents, the last of which expires in 2017.

In July 2004, Barr announced that the U.S. District Court in New Jersey had granted summary judgment of non-infringement with respect to three patents in the Company's patent challenge litigation involving Allegra (Fexofenadine Hydrochloride). On April 1, 2005, the Company announced that the Court granted summary judgment of invalidity on an additional patent in the case.

The court has yet to rule on five patents related to the Allegra tablet and capsule products remaining in the litigation -- three method-of-use patents and two raw material patents. While no trial date has been set, Barr anticipates that the case may be ready for trial early in 2006.

Source: Barr Pharmaceuticals, Inc.

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