Watson has filed an Abbreviated New Drug Application (ANDA) with the FDA seeking approval to market its guaifenesin pseudoephedrine HCI extended-release 600mg/60mg and 1200mg/120mg tablets prior to the expiration of patents owned by Reckitt Benckiser.
Watson’s guaifenesin pseudoephedrine HCI extended-release tablet products are the generic versions of Reckitt Benckiser‘s Mucinex 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 previously filed ANDAs seeking approval to market generic versions of Reckitt Benckiser Mucinex and Mucinex DM products.
On this Reckitt Benckiser filed suit against Watson Pharmaceuticals and Watson Laboratories on June 5, 2009 in the US District Court for the Southern District of Florida seeking to prevent Watson from commercializing its products prior to expiration of US patent numbers 6372252 and 6955821. Reckitt Benckiser’s suit resulting in a stay of final FDA approval of Watson’s ANDA for up to 30 months or until final resolution of the matter before the court, whichever occurs sooner.
Based on available information, Watson Pharmaceuticals believes that Watson Laboratories may be the first applicant to file an ANDA for a generic version of Mucinex D and, should its product be approved, may be entitled to 180 days of generic market exclusivity.