FDAnews
www.fdanews.com/articles/69041-court-rules-against-ferring-on-ddavp-patent-protection-ferring-to-appeal

Court Rules Against Ferring on DDAVP Patent Protection; Ferring to Appeal

February 22, 2005

Ferring Pharmaceuticals is appealing a recent court ruling that cut short its patent protection on antidiuretic treatment DDAVP -- a move that could delay the launch of a generic version of DDAVP by Barr Laboratories.

The U.S. District Court for the Southern District of New York ruled recently that Ferring's patents on DDAVP (desmopressin acetate) tablets were not enforceable and not infringed by Barr's planned generic version of the product. Ferring said it intends to appeal the court ruling.

Since Barr believes it was the first company to file an abbreviated new drug application for 0.1 and 0.2-mg strengths of desmopressin, the company believes it will obtain 180 days of marketing exclusivity upon FDA approval of the DDAVP. But Ferring said it is confident it can block generic entry for the drug.

"We are disappointed with this judgment and will definitely appeal," Ferring spokeswoman Michele Pettigrew said in a statement. "We believe that the facts support our case and are confident that our appeal will be successful."

DDAVP is a peptide-based synthetic analogue of the human antidiuretic hormone vasopressin, and is used as a therapy for central diabetes insipidus, for managing primary nocturnal enuresis and for treatment following head trauma or surgery in the pituitary region.