Teva, Barr will produce generic Fosamax

Merck & Co. Inc. yesterday lost exclusive patent protection on its blockbuster osteoporosis medicine Fosamax, and the company expects sales on its third-biggest product to significantly erode.

The bad news for Merck is good news for consumers, who will have lower-cost choices for the popular treatment, and for drug manufacturers, which are rushing generic versions to market.

Two large manufacturers, Teva Pharmaceutical Industries Ltd. and Barr Pharmaceuticals Inc., said that U.S. regulators had granted marketing approval for their generic versions of Fosamax and that they were ready to ship the products immediately to pharmacies.

Generic Fosamax is expected to boost the financial results of Teva, an Israeli company with North American headquarters outside Philadelphia in North Wales, and Barr, of Montvale, N.J.

Merck's worldwide sales of Fosamax totaled $3 billion last year, but they are expected to plunge in 2008 to $1.1 billion to $1.4 billion worldwide, the company said last month.

Teva and Barr are the first companies allowed to market generic versions of the drug for 180 days because they were the first to file with the U.S. Food and Drug Administration for marketing approval of their chemically equivalent generic formulations.

The six-month exclusivity will not stop Merck from selling its own generic, called an "authorized generic," with partner Watson Pharmaceuticals Inc.

Merck, based in Whitehouse Station, N.J., with significant operations in West Point, Montgomery County, plans to manufacture generic Fosamax, which will be distributed by Watson, in 35- and 70-milligram once-weekly tablets. Merck will share in the profits.

Merck said in its 2007 earnings release Jan. 30 that it anticipated a significant decline in U.S. sales of Fosamax and Fosamax Plus D, after both products lose market exclusivity - this month for Fosamax and in April for Fosamax plus Vitamin D.

Despite the loss of exclusivity for U.S. sales of Fosamax, Merck has said it expects solid earnings growth in 2008 from established and new products.

Teva said yesterday that its generic Fosamax, known by the chemical name alendronate sodium, would be sold in strengths of 5, 10, 35, 40 and 70 milligrams.

Barr announced that it would immediately sell generic Fosamax in 70-milligram tablets.

Generic drugs are chemically equivalent to brand-name drugs but often sell at one-third to one-half the price. Teva is the world's largest manufacturer of generic medicines.

Merck shares closed down 24 cents, or 0.52 percent, at $45.71. Teva shares closed up 22 cents, or 0.48 percent, at $46.20.