Friday, April 01, 2005

Barr wins a litigation in Allegra/Aventis decathalon

Barr Pharmaceuticals announced on April 1, 2005 that D NJ had invalidated a patent of Aventis related to Allegra-D (which includes the active ingredient fexofenadine).

Barr filed an Abbreviated New Drug Application (ANDA) for Fexofenadine HCl60 mg capsules in May 2001, an ANDA for Fexofenadine HCl 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. Then, Aventis filed Hatch-Waxman suits in 2001 in D NJ 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.

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.


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