Watson seeks FDA approval for generic Renvela, confirms patent challenge

MORRISTOWN, N.J. Generic drug maker Watson Pharmaceuticals hopes to be the first to market a version of a kidney disease treatment made by Genzyme, Watson said Monday.

Watson said it filed a regulatory approval application with the Food and Drug Administration for sevelamer carbonate for oral suspension. The drug is a generic version of Genzyme’s Renvela, used to control serum phosphorus in patients with chronic kidney disease who are on dialysis.

 

Watson’s application included a Paragraph IV certification, a legal assertion that the patents covering Renvela are invalid, unenforceable or won’t be infringed by a generic version, prompting Genzyme to file a patent infringement suit in the U.S. District Court for the District of Maryland. Watson’s case puts a stay of final FDA approval of Watson’s product for two and a half years or until the two companies resolve the matter before the court.

 

 

In May, Watson also filed for approval of a generic version of Renvela in tablet form.

 

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