Barr Laboratories Inc has received approval from the U.S. Food and Drug Administration (FDA) for its generic version of 3M Pharmaceuticals Tambocor (Flecainide Acetate) Tablets. Flecainide Acetate is a cardiovascular therapy for the prevention of certain arrhythmias. Barr expects to launch Flecainide Acetate during the second quarter of fiscal 2003.
Flecainide Acetate is available in 50mg, 100mg and 150mg tablet dosage strengths, and has current annual brand sales of approximately $110 million.
Barr filed an Abbreviated New Drug Application (ANDA) for Flecainide Acetate tablets with the U.S. Food and Drug Administration (FDA) in May 2000, and received notification of the application's acceptance for filing in July. Following receipt of notice from FDA, Barr notified 3M Pharmaceuticals.
On August 29, 2000, 3M Pharmaceuticals filed suit in U.S. District Court in Minnesota to prevent Barr from proceeding with the commercialization of this product. On April 18, 2001 the District Court for the District of Minnesota granted Barr's motion for summary judgment, and the decision was upheld by a Federal Appeals Court on May 1, 2002. Approval by the FDA follows the expiration of Alphapharm PTY Ltd.'s 180-days of market exclusivity, as the first to file a generic challenge for this product.
"We are pleased that FDA approval will enable us to add this cardiovascular therapy to our product line," said Bruce L. Downey, Barr's Chairman and CEO. "Our challenge was based on the fact that patents protecting this product were related to the raw material, and that our raw material did not infringe. This position was upheld by the courts."