FDA Gives Final Approval to Fenofibrate Tablets
May 19, 2005, 09:24, Reviewed by: Dr.
|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.
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.
- U.S. Food and Drug Administration (FDA)
Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 25 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients. Close to 90% of Teva's sales are in North America and Europe.
Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause Teva's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include Teva's ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competitive generic products, the impact of competition from brand-name companies that sell or license their own generic products (so called "authorized generics") or successfully extend the exclusivity period of their branded products, the effects of competition on Copaxone(R) sales, Teva's ability to rapidly integrate the operations of acquired businesses, including its acquisition of Sicor Inc., regulatory changes that may prevent Teva from exploiting exclusivity periods, potential liability for sales of generic products prior to completion of appellate litigation, including that relating to Neurontin, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Association and other regulatory authority approvals, the regulatory environment and changes in the health policies and structure of various countries, Teva's ability to successfully identify, consummate and integrate acquisitions, exposure to product liability claims, dependence on patent and other protections for innovative products, significant operations outside the United States that may be adversely affected by terrorism or major hostilities, fluctuations in currency, exchange and interest rates, operating results and other factors that are discussed in Teva's Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.
Contact Teva Pharmaceutical Industries Ltd. Dan Suesskind, (011) 972-2-589-2840 Dorit Meltzer, (011) 972-3-926-7554 or Teva North America George Barrett, 215-591-3030
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