Generic player Watson Pharma confirmed (in a press release Here) that it has filed Abbreviated New Drug Applications (ANDA) with Paragraph IV certification on Dextromethorphan HBr+ Guaifenesin 30 mg+600 mg and 60 mg+1200 mg ER tablets. Watson has challenged innovator Reckitt Benckiser following Orange Book listed patents on Dextromethorphan HBr+ Guaifenesin ER 30 mg+600 mg and 60 mg+1200 mg tablets (Mucinex):
US6372252 (Assignee: Adams Lab): Which covers a modified release tablet having two portions, wherein a first portion comprises a first quantity of guaifenesin in an immediate release form which becomes fully bioavailable in the subject's stomach and a second portion comprises a second quantity of guaifenesin and a release-delaying matrix comprising a hydrophilic polymer and a water-insoluble polymer wherein the weight ratio of said hydrophilic polymer to said water-insoluble polymer is in the range of from about 1:1 to about 6.8:1, wherein said tablet demonstrates a Cmax in a human subject equivalent to the Cmax obtained when the first of three doses of a standard immediate release formulation having one third the amount of guaifenesin is dosed every four hours over a 12 hour period, and wherein said tablet also provides therapeutically effective bioavailability for at least twelve hours after a single dose in a human subject according to serum analysis.
US6955821 (Assignee: Adams Lab): Which covers a modified release drug product comprising a first quantity of guaifenesin in an immediate release formulation wherein the guaifenesin becomes bioavailable in a subject's stomach; a second quantity of guaifenesin in a release-delaying matrix; and at least one additional drug, wherein the release-delaying matrix comprises a hydrophilic polymer and a water-insoluble polymer in a weight ratio of hydrophilic polymer to water-insoluble polymer from about 1:1 to about 9:1, wherein the immediate release formulation guaifenesin has a Cmax in a human subject equivalent to the Cmax obtained when a dose of a standard immediate release formulation having one third the amount of guaifenesin is dosed, and immediately after administration the serum concentration of guaifenesin peaks in about an hour, followed by a gradual serum concentration decrease over twenty-four hours but the serum concentration of guaifenesin never decreases below the minimum concentration of said standard immediate release formulation over twelve hours, and wherein the drug product releases a therapeutically effective bioavailable guaifenesin dose for at least twelve hours after a single dose in the human subject according to serum analysis.
Innovator Reckitt Benckiser has filed suit against Watson on April 20, 2009 in the U.S. District Court for the Southern District of New York seeking to prevent Watson from commercializing its products prior to expiration of ‘821 and ‘252 patents
Dextromethorphan HBr+ Guaifenesin ER tablets are indicated to help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
According to IMS Health data for the twelve-months ended December 31, 2008, Dextromethorphan HBr+ Guaifenesin ER tablets 30 mg+600 mg and 60 mg+1200 had total U.S. sales of approximately $106 million and $85 million respectively,.
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