Teva Pharmaceutical Industries Ltd. has announced that the US FDA has granted final approval for the Company's ANDA for Fenofibrate Tablets, 54 mg and 160 mg.

Fenofibrate Tablets are the AB-rated generic equivalent of Abbott's Tricor Tablets. This product is indicated for the treatment of hypercholesterolemia and hypertriglyceridemia.

The approval follows a ruling at the US District Court for the District of Delaware, which granted summary judgment of non-infringement in favour of Teva on certain patent claims at issue. The Court ruled that Teva's ANDA for Fenofibrate Tablets, which was made under Paragraph IV of the Hatch-Waxman Act, does not infringe US Patent Nos. 6,589,552 and 6,074,670, and one claim of US Patent No. 6,277,405, a release from Teva stated.

Abbott is no longer marketing the 54 mg and 160 mg strength tablets, having converted its Tricor product to 48 mg and 154 mg strength tablets during the pendency of the patent litigation and second 30-month stay. This is the second such market conversion undertaken by Abbott on Fenofibrate. Prior to this conversion, annual brand sales of the product were approximately $800 million.