Impax Laboratories, Inc. today announced that it has reached agreement with Genzyme, a Sanofi company, to settle pending U.S. litigation with regard to the production and sale of generic formulations of RENVELA® (sevelamer carbonate 800 mg tablet and oral suspension 2.4g and 0.8g) and RENAGEL® (sevelamer hydrochloride 400 mg and 800 mg tablets). Under the terms of the settlement, Genzyme has agreed to grant Impax a license to sell a generic version of RENVELA® tablets on March 16, 2014 or earlier under certain circumstances. Genzyme has also agreed to grant Impax a license to sell a generic version of RENVELA® for oral suspension and of RENAGEL® on September 16, 2014 or earlier under certain circumstances.
The Company believes that it is the first to file an ANDA with a paragraph IV certification with respect to the sevelamer carbonate 800 mg tablet product, and expects to be entitled to 180-days of market exclusivity prior to the launch of additional ANDA products. Upon the agreed-upon launch dates, Global Pharmaceuticals, Impax’s generic division, intends to commercialize the products.
RENAGEL® and RENVELA® are both indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis.
As reported by Sanofi, net sales of RENAGEL® and RENVELA® were 415 million € ($512 million based on a current exchange rate of $1.257) from April 1, 2011 to the end of the year. In the first half of 2012, net sales of RENAGEL® and RENVELA® were 312 million € ($392 million based on a current exchange rate of $1.257).
