Impax Ships Generic Renvela

Impax Laboratories said it has begun shipping generic Renvela tablets in the U.S. after securing a license from Genzyme to sell a specified number of bottles.

The license came after nearly four years of litigation, beginning in 2010 when Genzyme sued Impax over its Renvela (sevelamer carbonate) ANDA. The brand drugmaker alleged that Impax’s submission contained a Paragraph IV certification claiming Genzyme’s ‘775 patent is invalid.

Genzyme asked the U.S. District Court for the District of Maryland to issue an injunction preventing Impax from making or selling its version of the drug until after the ‘775 patent expires in September.

Impax said Tuesday that it continues to seek approval of generic Renvela, pending resolution of a warning letter at its Hayward, Calif., manufacturing plant.

The FDA approved Renvela in 2007, and the European Medicines Agency followed suit two years later. The drug is indicated for control of serum phosphorus in dialysis patients with chronic kidney disease.

According to IMS Health, Renvela garnered sales of about $907 million between February 2013 and February 2014. — Lena Freund

Subscribe to Drug Industry Daily for complete coverage of the pharmaceutical industry. Click here for more information.