Generic player Watson Pharmaceuticals has filed an Abbreviated New Drug Application (ANDA) with the USFDA seeking approval to market its Guaifenesin + Pseudoephedrine HCI Extended Release 600mg/60mg and 1200mg/120mg tablets prior to the expiration of patents owned by innovator Reckitt Benckiser (as confirmed in press release Here ).
Watson's Guaifenesin+ Pseudoephedrine HCI ER products are the generic versions of innovator Reckitt Benckiser Inc.'s Mucinex(R) D product, which are indicated to help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Watson has challenged innovator Reckitt Benckiser following Orange Book listed patents on Guaifenesin+ pseudoephedrine HCI 600mg/60mg and 1200mg/120mg ER tablets:
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.
Reckitt Benckiser filed suit against Watson on June 5, 2009 in the U.S. District Court for the Southern District of Florida seeking to prevent Watson from commercializing its products prior to expiration of Orange Book listed patents:
Probably, Watson is first Para IV filer on this product and entitled for prized 180 days exclusivity under Hatch-Waxma provision.
For the twelve-months ended March 31, 2009, Mucinex(R) D products had total U.S. sales of approximately $62 million, according to IMS Health data.
Earlier, Watson filed ANDAs seeking approval to market generic versions of Reckitt Benckiser's Mucinex(R) and Mucinex(R) DM products as reported by IP Pharma Doc Here.
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