Barr initiates patent challenge

Barr Pharmaceuticals has initiated a challenge on the patents listed by Sanofi-Avenits over its Uroxatral (alfuzosin hydrochloride extended-release tablets), 10mg.

The subsidiary of Barr Laboratories has disclosed that its Abbreviated New Drug Application (ANDA) contains a paragraph IV certification for a generic Uroxatral product and that it was approved by US Food and Drug Administration (FDA) in June of this year.

Barr was then prevented from proceeding with the marketing of the product after Sanofi-Aventis filed a suit in the district of Delaware.

Barr claims that its ANDA had been accepted for filing and that it notified the New Drug Application (NDA) and patent holder.

However under the Hatch-Waxman Act, the action taken by Sanofi-Aventis formally initiates the patent challenge while Barr has formally acknowledged that other companies have filed an ANDA for alfuzosin hydrochloride extended-release tablets, and have been sued

Earlier this year, Barr Pharmaceuticals saw the resignation of its chief operating officer Paul M Bisaro, who was also the board member for newly acquired Pliva.