Barr Pharmaceuticals, Inc. said its subsidiary, Barr Laboratories, Inc., has launched a generic version of Merck & Co., Inc.'s Fosamax (Alendronate Sodium) Tablets, 70 mg after receiving final approval from the US Food and Drug Administration (FDA).
The FDA approved the company's application on February 6, 2008, following the expiration of paediatric exclusivity associated with the earliest to expire of the patents listed with the FDA for Fosamax, 70 mg tablets. Barr obtained favourable resolutions with regard to the other patents listed for this product. Barr is entitled to share 180 days of marketing exclusivity for its 70 mg Alendronate Sodium product. This exclusivity bars the entry of competition for this product against generic competitors, other than an authorized generic and another company with which Barr shares exclusivity.
"Barr is pleased to be able to provide people suffering from osteoporosis and Paget's disease with a more affordable generic alternative," said Bruce L. Downey, chairman and chief executive officer, Barr. "This is particularly critical as our elderly population increases and seeks to maintain their quality of life in their advanced years."
Barr's Alendronate Sodium product is indicated for the treatment and prevention of osteoporosis in postmenopausal women; for the treatment to increase bone mass in men with osteoporosis; for the treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density; and for the treatment of Paget's disease of bone in men and women.
Fosamax Tablets, 70 mg had annual sales of approximately $1.7 billion in the United States, based on IMS sales data for the 12 months ending November 2007.
Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical company that operates in more than 30 countries worldwide and is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients.