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Watson Pharma Files for FDA OK on Generic Mucinex

By Pharmaceutical Processing | June 10, 2009

CORONA, Calif. (AP) — Watson Pharmaceuticals Inc. has asked the FDA to approve two more generic versions of the Reckitt Benckiser expectorant Mucinex. Watson said it filed for approval of generics of extended-release Mucinex, or guaifenesin, with pseudoepinephrine. The brand name drug is made by Reckitt Benckiser Inc. In April, Watson asked the FDA to approve generic versions of Mucinex and Mucinex DM. Watson said sales of extended-release Mucinex totaled $62 million last year. Reckitt Benckiser filed suit against Watson on Friday to prevent it from selling its generics before the patents supporting Mucinex expire. The suit triggers a mandatory waiting period before the FDA can approve the generic version. The agency will wait for 30 months, or until a court makes a ruling on the patent.

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