The FDA has approved generic drug following the expiration of pediatric exclusivity associated with the earliest to expire of the patents listed with the FDA for Fosamax, 70mg tablets. Barr obtained favorable resolutions with regard to the other patents listed for this product. Barr is entitled to share 180 days of marketing exclusivity for its 70mg alendronate sodium product.
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 7.5mg 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.