Aurobindo's generic drug for osteoporosis approved by US FDA

Published: 9-Dec-2015
Media Regulatory

The global osteoporosis drugs market is seeing significant growth due to a rising geriatric population and changing lifestyles


India's Aurobindo Pharma has received final approval from the US FDA to manufacture and market the generic version of Risedronate Sodium tablets, used in the treatment of osteoporosis, in the American market.

The approval is an extension of a tentative nod received by the company on 10 October 2012.

Aurobindo's product is therapeutically equivalent to Warner Chilcott's Actonel tablets, which are also used in the treatment of osteoporosis.

The approved product had an estimated market size of US$113m for the 12 months ending October 2015, according to IMS data.

The osteoporosis drugs market is anticipated to grow from an estimated $11.23bn in 2015 to $14.8bn by 2022 at a CAGR of 4.0% during the forecast period.

The global osteoporosis drugs market is seeing significant growth due to a rising geriatric population and changing lifestyles impinging on bone health. Increasingly, the prevalence of osteoporosis in postmenopausal women, growing awareness about osteoporotic care, and increasing investment in drug discovery and development are driving the growth of the market.

While North America is the largest market for osteoporosis drugs, with bisphosphonates being the most popular type of treatment, Asia-Pacific is the fastest growing region in terms of revenue.

  • Companies:
  • Aurobindo
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