Renagel/Renvela (sevelamer hydrochloride and sevelamer carbonate)
Chronic Kidney Disease
Global Sales 2012: $861 million
U.S. Sales 2012: $595 million
Expiration Date: September 2014, March 2014 generic launch under license
Acquired by Sanofi ($SNY) when it bought Genzyme, Renagel and Renvela aren't blockbusters. But the two drugs, designed to lower phosphorus levels in patients with chronic kidney disease, have been solid performers for the company. Genzyme is one of the "growth platforms" CEO Christopher Viehbacher points to when announcing quarterly results, and Renvela and its newer follow-up Renagel have done their part to prove it. Global sales of the two were $861 million for 2012, up from $538 million in 2011; for the first half of 2013, they brought in €346 million, or about $450 million.
That's about to change. After a patent fight with Impax Laboratories ($IPXL), Sanofi last year agreed to allow the generics maker to launch Renvela tablets in March 2014. Renvela's liquid formulation and Renagel tablets are set to follow in September. Impax has first-to-file status with the FDA, so each formula will face only one generic rival for its first 6 months on the market. Multiple competitors will hit after that, kicking in price competition--and that's when the branded versions will begin to suffer most.
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-- Tracy Staton (email | Twitter)