Innovator Genzyme had sued Indian generic players Lupin for allegedly filing ANDA with Paragraph IV certification as part of Lupin's generic version of Genzyme's Sevelamer Carbonate (Renvela) 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
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.
US6858203 (Expiry: Aug 11, 2013): The patent covers method for removing phosphate from a patient comprising orally administering to said patient a therapeutically effective amount of a composition comprising at least one polymer characterized by a repeat unit (in a markush structure) and or a copolymer thereof, wherein each n is an integer, each R, independently, is H or a lower alkyl, alkylamino, or aryl group, and each X.sup.- is a carbonate or bicarbonate anion
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 Lupin for the infringement of '545, '775, '013, ‘203 and '846 patents in District Court of Maryland.
Earlier, Lupin sent its Para IV letter to innovator, accordingly, innovator sued lupin within 45 days to delay Lupin's ANDA approval for 30 months.
This formulation is protected by new salt exclusivity, which will expire on Oct 19, 2010.
Earlier, innovator sued Lupin for filing para IV on Renagel (Sevelamer hydrochloride) as reported by us Here.
Also, innovator has sued Impax for this product as reported by us earlier.
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.
About Renvela
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.
About Lupin
Lupin is an aggressive Indian generic player and in recent times have many First To File Para IV filings and other Para IV challenges to its credit. Recently, Lupin settled patent litigation on Venlafaxine extended release (Effexor) capsules as reported in their press release Here
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