Teva Pharmaceutical Industries Ltd announced that the U. S. Food and Drug Administration has approved the company's ANDA for Hydrocodone Bitartrate and Ibuprofen Tablets, 7.5 mg/200 mg. This approval follows a September 12, 2002 summary judgment decision in favor of Teva invalidating the patent asserted by Abbott. Abbott's appeal is pending. Shipment of this product will begin immediately.
Hydrocodone Bitartrate and Ibuprofen Tablets are the AB-rated generic equivalent of Abbott's Vicoprofen Tablets, indicated for short-term management of acute pain.. Annual sales of the brand are approximately $104 million. Teva's approval is the first for this generic product.