Generic player Impax Lab confirms (in a press release Here) that it has initiated a challenge of the patents listed by Genzyme Corporation in connection with its RENAGEL® (Sevelamer hydrochloride) tablets, 400 mg and 800 mg.
Impax filed its Abbreviated New Drug Application (ANDA) containing a paragraph IV certification for a generic version of RENAGEL® with the U.S. Food & Drug Administration (FDA). Following receipt of the notice from the FDA that Impax's ANDA had been accepted for filing, Impax notified the New Drug Application holder and patent owner of its paragraph IV certification.
Following patents are listed in Orange Book for this product:
US5496545 (Expiry: Aug 11, 2013): The patent covers formulation and method of use
US5667775 (Expiry: Sep 16, 2014) : The patent covers a method for removing phosphate from a patient by ion exchange comprising orally administering to said patient a therapeutically effective amount of a composition comprising Sevelamer
US6509013 (Expiry: Aug 11, 2013): The patent covers a pharmaceutical composition consisting essentially of a carrier and at least one water insoluble, crosslinked polymer
US7014846 (Expiry: Aug 11, 2013): The patent covers a pharmaceutical composition comprising a carrier and a crosslinked, water insoluble polyallylamine homopolymer, wherein said polyallylamine homopolymer comprises repeat units wherein said polyallylamine homopolymer is crosslinked with an epichlorohydrin crosslinking agent, and wherein the homopolymer is fully protonated, partially protonated or unprotonated.
US6733780 (Expiry: Oct 18, 2020): The patent covers a tablet comprising a core and a coating thereof, wherein at least about 95% by weight of the core is an aliphatic amine polymer selected from the group consisting of unsubstituted and N-substituted poly(allylamine), poly(diallylamine), and poly(vinylamine).
US7459151 (Expiry: Aug 11, 2013): The patent covers a method for removing phosphate from a patient in need thereof comprising orally administering to said patient a therapeutically effective amount of a pharmaceutical composition comprising a crosslinked, water insoluble polyallylamine copolymer wherein said crosslinked, water insoluble polyallylamine copolymer consists of a crosslinking agent
Innovator Genzyme has sued Impax On March 13, 2009 for the infringement of '545, '775, '013 and '846 in United States District Court for the District of Maryland.
Also, innovator has sued Lupin for the infringement of '545, '775, '013 and '846 in Delaware District Court as reported earlier by IPPharmadoc Here.
Sevelamer (Renegal) is a phosphate binder indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis.
According to Wolters Kluwer Health, U.S. sales of RENAGEL® were approximately $469 million across both strengths for the period ending January 2009.
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