From rxpgnews.com
FDA Gives Final Approval to Fenofibrate Tablets
By Teva Pharmaceutical
May 19, 2005, 09:24
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration 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(R) Tablets. This product is indicated for the treatment of hypercholesterolemia and hypertriglyceridemia.
Today's approval follows a ruling at the U.S. 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 Court ruled that Teva's ANDA for Fenofibrate Tablets, which was made under Paragraph IV of the Hatch-Waxman Act, does not infringe U.S. Patent Nos. 6,589,552 and 6,074,670, and one claim of U.S. Patent No. 6,277,405.
The FDA had initially granted tentative approval of Teva's ANDA in March 2004. At that time, Teva was subject to a second 30-month stay with respect to U.S. Patent No. 6,589,552, which Teva has now been found to not infringe. The court has yet to rule on certain claims relating to U.S. Patent Nos. 6,277,405 and 6,652,881. A trial on these two patents is scheduled for June 6, 2005.
Abbott is no longer marketing the 54 mg and 160 mg strength tablets, having converted its Tricor(R) 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.
In late 2001, Abbott began to convert the previous market for Fenofibrate Capsules to the 54 mg and 160 mg Fenofibrate Tablet products. At that time, Teva had an ANDA pending for Fenofibrate Capsules. Teva received FDA approval to market a generic capsule product following summary judgment on all Orange Book patents, but only after Abbott had ceased sales of its capsule products and had taken steps to frustrate Teva's ability to fully commercialize that product as a generic.
Shortly following Abbott's announcement last year that it was planning to switch the market to a different tablet formulation, Teva filed a motion to amend its answer to assert antitrust counterclaims against Abbott, contending that Abbott's actions have frustrated generic competition in Fenofibrate products through a combination of two market conversions and the gaming of the Hatch-Waxman Act, 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.
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