Teva Pharmaceutical Industries Ltd. announced that the English Court of Appeal unanimously affirmed the decision of the English Patents Court and ruled in favor of Teva and two other companies that two Merck patents, relating to Fosamax are invalid.
One of the patents relates to pharmaceuticals containing the active ingredient of Merck's Fosamax and the second patent relates to its once weekly administration.
Alendronate sodium tablets are the generic equivalent of Merck's Fosamax tablets. The product is indicated for the treatment and prevention of osteoporosis and the treatment of Paget's disease. Annual branded sales of Fosamax in the UK are approximately £ 55 million.
Our application for regulatory approval is under review and we will launch this product only after receiving the required authorizations, which we do not expect before late 2004.