FDA approves generic osteoporosis drug

Generics/News | Posted 14/03/2014 post-comment0 Post your comment

FDA announced on 4 March 2014 that it had approved Teva Pharmaceutical Industries (Teva’s) generic version of Eli Lilly’s osteoporosis drug Evista (raloxifene).

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Raloxifene is an oral selective estrogen receptor modulator (SERM) that has estrogenic actions on bone and anti-estrogenic actions on the uterus and breast. Evista is used to treat and prevent osteoporosis (a condition in which the bones become thin and weak and break easily) in postmenopausal women. Evista can also be used to lower the risk of getting invasive breast cancer.

According to the International Osteoporosis Foundation, around the world, 1 in 3 women and 1 in 5 men over the age of 50 are at risk of an osteoporotic fracture. In fact, an osteoporotic fracture is estimated to occur every three seconds.

Evista had sales of US1.05 billion in 2013, a 4% increase on 2012, according to data from Eli Lilly’s 2013 investor report. The patents on Evista for use in osteoporosis expired on 2 March 2014. However, patents on the drug’s use for the prevention of breast cancer remain in place until 10 March 2017.

Teva’s generic raloxifene will be available as a 60 milligram strength tablet. Teva was the ‘first-to-file’, giving the generics company 180 days of marketing exclusivity. Teva expects to start shipping the product within the next 30 days.

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Source: Eli Lilly,FDA, IOF, Teva

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