Barr beats Ferring BV and Aventis Pharmaceuticals Inc. in antidiuretic case
A decision in the SDNY clears the way for the Food and Drug Administration to approve Barr's pending application to market a generic version of DDAVP (desmopressin acetate). Barr said it is the first to file an abbreviated new drug application for the doses and has 180 days of exclusivity on the products.
Barr filed an ANDA in July 2002, and was sued Dec. 13, 2002 [?] by Ferring and Aventis. Ferring manufactures DDAVP for Aventis, which markets the product in the United States. Barr filed for summary judgment in April 2004.
DDAVP tablets had annual sales of $177 million last year. They are indicated as antidiuretic replacement therapy in the management of central diabetes insipidus - a disorder of the pituitary gland characterized by intense thirst and by the excretion of large amounts of urine - and for the management of the temporary excessive urination and thirst following head trauma or surgery in the pituitary region. They are also indicated for the management of primary nocturnal enuresis, or bed-wetting.