The Israeli company was first to file, making the product eligible for 180 days of market exclusivity. Risedronate sodium tablets, USP are the second approved product indicated to treat osteoporosis in Teva’s generic portfolio.
Designed to treat or prevent osteoporosis in women after menopause, the risedronate sodium tablets help increase bone mass and reduce the chance of having a spinal or non-spinal fracture (break).
These tablets are also used to treat or prevent osteoporosis in men and women who are taking corticosteroid medicines, and to treat Paget’s disease of the bone.
According to IMS data, Actonel tablets marketed by Actavis had annual sales of about $157m in the US, in 2014.
In the US, around 54 million people have low bone mass and osteoporosis, a condition that causes the bones to become weak and brittle.