Barr Pharmaceuticals, Inc., a holding company that operates through its principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., announced that the U.S. District Court in New Jersey has granted summary judgment of invalidity on an additional patent in their litigation challenging the patents on Allegra(R) (Fexofenadine Hydrochloride) allergy treatment products. The court had previously granted summary judgment of non-infringement with respect to three other patents in the case and has yet to rule on six patents remaining in the litigation.
Barr filed an Abbreviated New Drug Application (ANDA) for Fexofenadine HCI 60 mg capsules in May 2001, an ANDA for Fexofenadine HCI 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.
Aventis filed suits in 2001 trying to prevent approval of Barr’s ANDAs until after the expiration of various patents, the last of which expires in 2018. For the 12 months ending January 2005, Allegra tablets had sales of approximately $1.5 billion, while Allegra-D had annual sales of approximately $432 million.
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