Barr launches generic Fosamax following final FDA approval

MONTVALE, N.J. Barr Laboratories has launched a generic version of Merck’s osteoporosis drug Fosamax tablets, 70 mg after receiving final approval from the Food and Drug Administration.

Barr is entitled to share 180 days of marketing exclusivity for its 70 mg alendronate sodium product. Barr will share this exclusivity with Teva and any authorized generics that Merck plans on introducing with another company.

“Barr is pleased to be able to provide people suffering from osteoporosis and Paget’s disease with a more affordable generic alternative,” said Bruce Downey, Barr’s chairman and chief executive officer. “This is particularly critical as our elderly population increases and seeks to maintain their quality of life in their advanced years.”

Fosamax 70 mg had annual sales of approximately $1.7 billion in the U.S., based on IMS sales data for the 12 months that ended November 2007.