KV Pharmaceutical Company announced that it has begun shipment of its 100 mg and 200 mg strengths of metoprolol succinate extended release tablets.
Based on the company's first-to-file status on its ANDA for these two strengths, KV anticipates being accorded the benefit of a 180-day generic exclusivity period for the marketing of these two dosage strengths. The company also announced that the US Court of Appeals for the Federal Circuit has affirmed the judgment in the company's favour in its patent litigation with AstraZeneca. The decision clears the way for the company to market its metoprolol succinate extended-release tablets without interference from the AstraZeneca patents.
Marc S. Hermelin, chairman of the board and chief executive officer of KV Pharmaceutical Company stated, "Today marks a major milestone for our company. Our entire KV team has worked hard to accomplish this achievement and we look forward to the execution of a successful launch of this product through our outstanding team at ETHEX Corporation. Many individuals contributed to making the regulatory approval, manufacturing and launch of Toprol-XL a reality and we now look forward to pursuing our strategy for maximizing the value of this asset not only during the remainder of fiscal 2008, but into the future as well."
KV Pharmaceutical Company is a fully integrated specialty pharmaceutical company that develops, manufactures, acquires and markets technology-distinguished branded and generic/non-branded prescription pharmaceutical products. The Company markets its technology distinguished products through ETHEX Corporation, a national leader in pharmaceuticals that compete with brands, and Ther-Rx Corporation, its emerging branded drug subsidiary.