Fenofibrate tablets are the AB-rated generic equivalent of Abbott’s Tricor tablets, which are indicated for the treatment of hypercholesterolemia and hypertriglyceridemia.
The FDA approval follows a ruling at the US District Court for the District of Delaware, which granted summary judgment of non-infringement in favor of Teva on certain patent claims at issue.
The FDA had initially granted tentative approval of Teva’s abbreviated new drug application (ANDA) in March 2004. At that time, Teva was subject to a second 30-month stay with respect to a US patent, which the company has now been found to not infringe. The court has yet to rule on certain claims relating to two other US patent, a trial on which is scheduled for June 6, 2005.
Abbott is no longer marketing the 54mg and 160mg strength tablets, having converted its Tricor product to 48mg and 154mg 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.
Shortly following Abbott’s announcement last year that it was planning to switch to a different tablet formulation, Teva filed to assert antitrust counterclaims against Abbott, contending that Abbott’s actions have frustrated generic competition in Fenofibrate products, denying consumers access to a generic alternative to Abbott’s products. Teva is seeking triple damages, including lost profits and attorneys’ fees, as provided for under the antitrust laws.