Impax settles patent dispute with Genzyme

Generics/News | Posted 14/09/2012 post-comment0 Post your comment

Impax Laboratories (Impax) announced on 4 September 2012 that it had reached an agreement with Sanofi subsidiary, Genzyme Corporation (Genzyme), to settle pending US litigation with regard to the production and sale of generic versions of Renvela (sevelamer carbonate) and Renagel (sevelamer hydrochloride).


Genzyme filed a patent infringement suit against Impax on 19 November 2010 after Impax filed its Abbreviated new Drug Application (ANDAs) with FDA for generic versions of Renagel and Renvela.

US-based Impax 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, giving the generics maker 180-days of market exclusivity. Impax intends to commercialise the drugs through its generics division, Global Pharmaceuticals.

Renagel and Renvela are both indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis. Sales of Renagel and Renvela were Euros 415 million from 1 April 2011 to end 2011, according to Sanofi. In the first half of 2012, net sales of Renagel and Renvela were Euros 312 million.

The agreement covers the 800 mg tablet and 2.4 g and 0.8 g oral suspensions of Renvela and the 400 mg and 800 mg tablets of Renagel. The core patent on Renagel/Renvela expires in 2014. Under the terms of this agreement with genzyme, Impax will be able to start selling Renvela tablets on 16 March 2014 and Renvela oral suspension and Renagel as of 16 September 2014 or earlier under certain circumstances.

This is good news for Impax, which develops controlled-release and specialty generics in addition to the development of brand-name products. The company has been under a barrage of patent litigation from Abbott, Alza Corporation and Daiichi Sankyo, to name just a few, after submitting ANDAs for a whole range of generics [1].

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1.  GaBI Online - Generics and Biosimilars Initiative. New ANDAs and patent challenges for Impax Laboratories []. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Sep 14]. Available from:

Source: Impax

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