FDAnews Drug Daily Bulletin

As Merck’s blockbuster osteoporosis treatment Fosamax loses patent protection, Watson Pharmaceuticals is planning to ship an authorized generic of the drug.

Watson will market the 35- and 70-mg dosage strengths of Fosamax (alendronate sodium). Merck’s other formulation of the drug, Fosamax Plus D (alendronate sodium/cholecalciferol), is expected to lose exclusivity in April.

Final approval of Barr Pharmaceuticals’ 70-mg dosage form of the product is expected when pediatric exclusivity on the Fosamax ’575 patent expires Feb. 6. Barr has said it will share 180-day marketing exclusivity for the generic with Teva Pharmaceutical Industries. Both companies have multiple tentatively approved applications pending at the FDA.