View printer-friendly version
« Back
September 04, 2002 4:19 p.m.
Teva Announces Approval of Fenofibrate Capsules (micronized), 67mg. will Have 180 Days of Marketing Exclusivity

Jerusalem, Israel, September 4, 2002 - 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 Capsules (Micronized), 67 mg. The 134 mg and 200 mg strengths were approved April 9, 2002 following a favorable ruling on a motion for summary judgement. Approval of the 67 mg strength was granted upon the expiration of the 30-month clock which resulted from patent litigation. As the first company to file an ANDA with a Paragraph IV patent certification, Teva has been awarded 180 days marketing exclusivity for this product. Therefore, this exclusivity period will begin upon Teva's first commercial marketing of the 67 mg strength.

Fenofibrate Capsules (Micronized) are the AB-rated generic equivalent of Abbott's Tricor Capsules, Micronized, for the treatment of patients with very high elevations of serum triglyceride levels. Annual sales of the 67 mg strength of the brand product are approximately $14 million.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 35 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. Over 80% of Teva's sales are in North America and Europe. The company develops, manufactures and markets generic and branded human pharmaceuticals and active pharmaceutical ingredients.

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 current 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 their own generic products or successfully extend the exclusivity period of their branded products, Teva's ability to rapidly integrate the operations of acquired businesses, the availability of product liability coverage in the current insurance market, 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 ("FDA") and other regulatory authority approvals, the regulatory environment and changes in the health policies and structure of various countries, acceptance and demand for new pharmaceutical products and new therapies, uncertainties regarding market acceptance of innovative products newly launched, currently being sold or in development, the impact of restructuring of clients, reliance on strategic alliances, exposure to product liability claims, dependence on patent and other protections for innovative products, 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 ("SEC"). 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.