Watson Pharmaceuticals, Inc, a leading specialty pharmaceutical company, confirmed that its subsidiary, Watson Laboratories, Inc - Florida, has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration 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 Inc. Watson Laboratories, Inc - Florida's guaifenesin pseudoephedrine HCI extended-release tablet products are the generic versions of Reckitt Benckiser Inc'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 Laboratories, Inc - Florida previously filed ANDAs seeking approval to market generic versions of Reckitt Benckiser Inc's Mucinex and Mucinex DM products.
Reckitt Benckiser filed suit against Watson Pharmaceuticals, Inc and Watson Laboratories, Inc - Florida 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 6,372,252 and 6,955,821. Reckitt Benckiser's suit was filed under the provisions of the Hatch Waxman Act, resulting in a stay of final FDA approval of Watson Laboratories, Inc - Florida'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, Inc believes that Watson Laboratories, Inc - Florida may be the first applicant to file an ANDA for a generic version of Mucinex(R) D and, should its product be approved, may be entitled to 180 days of generic market exclusivity.
For the twelve-months ended March 31, 2009, Mucinex D products had total US sales of approximately $62 million, according to IMS Health data.
Watson Pharma is a global leader in the development and distribution of pharmaceuticals with a broad portfolio of generic products and a specialized portfolio of brand pharmaceuticals focused on urology, women's health and nephrology/medical.