Court Grants Barr Summary Judgment in DDAVP(R) Patent Challenge
Barr Pharmaceuticals, Inc. announced that the U.S. District Court for the Southern District of New York has granted summary judgment in favor of its wholly owned subsidiary, Barr Laboratories, Inc., in the Company's challenge to the patents for DDAVP(R) (desmopressin Acetate) Tablets. The court ruled that the patents alleged to cover DDAVP are unenforceable and not infringed by Barr's product. The court's decision effectively ends the 30-month stay on U.S. food & Drug Administration (FDA) approval of Barr's products, and allows FDA to approve Barr's products in the normal course.
The Company's application to market a generic version of DDAVP is currently pending at FDA. The Company believes that it is the first to file an Abbreviated New Drug Application (ANDA) with the FDA for DDAVP Tablets, 0.1 mg and 0.2 mg, and has the right to 180 days of exclusivity on the products.
Barr filed an ANDA for Desmopression Acetate Tablets, 0.1 mg and 0.2 mg, with the FDA in July 2002, and was sued on December 13, 2002, by Ferring B.V. and Aventis Pharmaceuticals, Inc. Ferring manufactures DDAVP(R) Tablets for Aventis, which markets the product in the United States. Barr filed for summary judgment in April 2004.
DDAVP Tablets are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus and for the management of the temporary polyuria and polydipsia following head trauma or surgery in the pituitary region. They are also indicated for the management of primary nocturnal enuresis.
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