Innovator Genzyme had sued Indian generc players Lupin for allegedly filing ANDA with Paragraph IV certification as part of Lupin's generic version of Genzyme's Sevelamer hydrochloride (Renagel) 400 and 800 mg tablets.
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
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 has sued Lupin for the infringement of '545, '775, '013 and '846 in Delaware District Court.
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 has sued Lupin for the infringement of '545, '775, '013 and '846 in Delaware District Court.
Earlier, Lupin sent its Para IV letter to innovator on January 20, accordingly, innovator sued lupin within 45 days to delay Lupin's ANDA approval for 30 months.
Sevelamer was first disclosed in USSR patent 417441 (patent by Tashkent Polytechnic University), accordingly, there is no product patent for this compound. Further, to thwart generic challenge innovator has listed patents covering method of use and formulation in Orange Book.
Genzyme had sales last year of $678 million for Renagel and a companion drug, Renvela, the company said last month. Renegal is used for the control of serum phosphorus in patients with chronic renal failure and on dialysis. Genzyme reported $4.6 billion in total revenue for 2008.
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