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news.A US court has ruled in favor of Barr Pharmaceuticals subsidiary Barr Laboratories in the company's challenge to the patents for antidiuretic tablets held by Ferring BV and Aventis Pharmaceuticals.
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The court ruled that the patents alleged to cover DDAVP (desmopressin acetate) are unenforceable and not infringed by Barr’s product. The court’s decision effectively ends the 30-month stay on FDA approval of Barr’s products, and allows the FDA to approve Barr’s products in the normal course.
The company’s application to market a generic version of DDAVP is currently pending with the FDA. Barr believes that it is the first to file an abbreviated new drug application (ANDA) with the FDA for DDAVP tablets 0.1mg and 0.2mg and has the right to 180 days of exclusivity on the products.
“We are very pleased that the Court has found in our favor,” said Bruce L. Downey, Barr’s chairman and CEO. “While we evaluate this opinion, we will continue to seek approval of our application. We also believe that the citizen’s petition currently pending at FDA regarding DDAVP is without merit, and we will vigorously oppose it, if necessary.”
Barr filed an ANDA for desmopression acetate tablets 0.1mg and 0.2mg with the FDA in July 2002, and was sued on December 13, 2002, by Ferring BV and Aventis Pharmaceuticals. Ferring manufactures DDAVP tablets for Aventis, which markets the product in the US. 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.