View printer-friendly version
« Back
August 23, 2000 3:30 p.m.
Teva Received Two Approvals:Final Approval for Enalapril to be Shipped Immediately Tentative Approval for Loratadine

Jerusalem, Israel, August 23, 2000 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that it has received from the U.S. FDA final approval to manufacture and market Enalapril Maleate 2.5, 5, 10 and 20mg Tablets.

Enalapril Maleate is the generic version of Merck's Vasotec® which is an ACE inhibitor indicated for the treatment of hypertension. Combined annual branded sales are approximately $690 million.
Teva received the final approval upon the expiration of the patent on the branded product and will ship the product immediately. Other companies have received similar approval.

Teva has also received tentative approval for Loratadine 10mg Tablets. Loratadine is the generic version of Schering-Plough's Claritin® and is indicated for the relief of nasal and non-nasal symptoms of seasonal allergic rhinitis. Current US sales of the branded product, are approximately $1.4 billion per annum. Teva is currently in patent litigation on Loratadine under the Hatch-Waxman legislation. Teva expects that another company may be eligible for the 180 days of market exclusivity and that the market will have multiple competitors thereafter.

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 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.