Generic Actonel Osteoporosis Drug Launched in US

Teva recently launched risedronate sodium tablets, the generic version of Actavis’s Actonel bisphosphonate, in 3 dosage strengths.

Risedronate sodium is indicated to treat or prevent postmenopausal osteoporosis, as it can help increase bone mass and reduce the odds of a spinal or non-spinal fracture. The bisphosphonate is also used to treat or prevent glucocorticoid-induced osteoporosis in both men and women, as well as treat Paget's disease.

The generic product is now available in 5-mg, 30-mg and 35-mg tablet strengths in the United States. Since Teva was first to file, the product is eligible for 180 days of market exclusivity.

As of December 2014, Actonel had annual sales of about $157 million in the United States.

The most common side effects associated with risedronate sodium tablets include back pain, abdominal pain, and skin reactions. Some serious side effects that have been reported include bone or joint pain, muscle pain, and low trauma fractures.

Risedronate may also cause irritation in the upper gastrointestinal mucosa. For this reason, those with known esophageal diseases must be evaluated for potential adverse effects. Health care professionals should instruct patients who develop dysphagia, odynophagia, retrosternal pain, or new or worsening heartburn to discontinue risedronate treatment and seek medical help.