Lanthanum carbonate (Fosrenol) Chewable tablets 500mg, 750mg and 1gm: Innovator Shire confirmed that Barr and Mylan filed Para IV

Innovator Shire, announced (in a press release here) that it has received Paragraph IV Notice letters from two generic players Barr Lab and Mylan dated February 2 and 4, 2009 respectively, advising in each case of the filing of an Abbreviated New Drug Application for a generic version of 500mg, 750mg and 1gm FOSRENOL(R), (Lanthanum carbonate) chewable tablets.
Innovator has following 3 Orange Book listed patents for Lanthanum carbonate (Fosrenol) Chewable tablets 500mg, 750mg and 1gm:
US5968976 (Expiry: Oct 26, 2018): Which coves a pharmaceutical composition for the treatment of hyperphosphataemia comprising lanthanum carbonate
US7381428 (Expiry: Aug 26, 2024): Which coves a stabilized Lanthanum Carbonate Compositions against substantial decarboxylation to lanthanum hydroxycarbonate before administration by admixing the lanthanum carbonate in an amount of from 13.4-13.9% to 32.2-33.3% by weight of the composition as elemental lanthanum with a monosaccharide or disaccharide in an amount from 20 to 80% by weight of the composition, wherein the monosaccharide or disaccharide is dextrates, mannitol, sorbitol, or a mixture thereof and the amount of the monosaccharide or disaccharide is such that lanthanum hydroxycarbonate is not observed in an x-ray powder diffraction (XRPD) pattern of the lanthanum carbonate composition after it has been exposed to 60 degree C and 95% relative humidity for at least 7 days.
US7465465 (Expiry: Aug 26, 2024): Which coves a lanthanum carbonate pharmaceutical formulation in a chewable tablet, comprising lanthanum carbonate in an amount of from about 200 mg to about 1000 mg elemental lanthanum in the proportion of about 10 to about 40 wt % of the formulation as elemental lanthanum and pharmaceutically acceptable excipients comprising a diluent in an amount from about 40 to about 80 wt % of the formulation and a flow agent in an amount from about 0.1 to about 5.0 wt % of the formulation, produced by a process which comprises the steps of: a. blending the lanthanum carbonate and the pharmaceutically acceptable excipients to form a mixture; or b. blending the lanthanum carbonate and the pharmaceutically acceptable excipients, compressing the resulting combination into a slug material or roller compacting the resulting combination into a strand material, and milling the prepared material into a free flowing mixture; and c. compressing the mixture formed in steps a or b into a tablet, wherein the process is performed without wet granulation or drying, the diluent is dextrates, corn syrup, oligosaccharide, isomaltooligosaccharide, glucose, lycasin, xylitol, lactitol, erythritol, mannitol, isomaltose, polydextrose, dextrin, starch, fructose, xylitol, maltodextrin, maltitol, isomalt, lactose, sorbitol, microcrystalline cellulose, sucrose based diluent-binders, confectioner's sugar, calcium sulfate dihydrate, calcium lactate trihydrate, hydrolysed starches, dextrose, inositol, hydrolyzed cereal solids, amylase, or glycine, and the flow agent is magnesium stearate, talc, polyethylene glycol, silica, colloidal anhydrous silica, hydrogenated vegetable oils, glyceryl behenate, or glyceryl monostearate.
innovator Shire believes these patents provide a robust and sustainable proprietary position for FOSRENOL under U.S. patent laws.
Shire is currently reviewing the detail of the Paragraph IV Notice letters from Barr and Mylan, and under the Hatch Waxman Act, has 45 days from the date of each notice letter to determine if it will file a patent infringement suit. If Shire brings suit pursuant to the Hatch Waxman regulations, a 30-month stay of approval will be imposed by the FDA on Barr's and Mylan's ANDA, which will commence on 26 October 2009.
Earlier, Innovator got approval for Lanthanum carbonate (Fosrenol) Chewable tablets 500mg on Oct 26, 2004, while, 750mg and 1gm were approved by USFDA on Nov 23, 2005