View printer-friendly version
« Back
June 07, 2000 3:26 p.m.
Teva Pharmaceutical Industries Ltd Receives Final FDA Approval of Nabumetone 750mg 180 Days Market Exclusivity Under Paragraph IV

Jerusalem, Israel, June 7, 2000 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that it has received from the US FDA final approval to manufacture and market Nabumetone 750mg Tablets.

Nabumetone is the generic version of the SmithKline Beecham drug Relafen®, for the treatment of acute and chronic osteoarthritis and rheumatoid arthritis.

Relafen® is being marketed in the U.S. in two strengths (500mg and 750mg). The 750mg approval is in addition to the 500mg approval Teva received last week.

Teva, as previously announced, was the first to file an application with the FDA for Nabumetone 500mg, and Copley (acquired by Teva last year) was the first to file for Nabumetone 750mg. Both fillings include Paragraph IV certifications under the Waxman-Hatch Act. Teva will therefore have 180 days of market exclusivity for both strengths. 1999 US sales of the branded products were approximately $380 million ($220 million for the 500mg strength and $160 million for the 750mg strength).

As with Nabumetone 500mg, prior to making a decision on the launch of Nabumetone 750mg, Teva awaits the outcome of a patent infringement case currently pending in a US Federal District Court in Massachusetts relating to these products.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 50 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. Over 80% of Teva's sales are outside Israel, mainly in the United States 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.