Sunday, March 19, 2017

Dextromethorphan hydrobromide & Guaifenesin - USA

On Mar 06, 2017, in Reckitt Benckiser LLC v. Aurobindo Pharma Ltd., the Delaware Court granted Defendants’ motion for summary judgment of non-infringement of the asserted claims of U.S. Patent No. 6,955,821 (“the ‘821 patent”) and U.S. Patent No. 7,838,032 (“the ‘032 patent”) with respect to Defendants’ proposed generic version of Mucinex® DM, an extended-release tablet that contains dextromethorphan hydrobromide and guaifenesin.

The claim limitations of the patents-in-suit require the claimed drug product to include both an immediate-release formulation and a sustained release formulation of the drug guaifenesin. Defendants moved for summary judgment on the basis that Plaintiff failed to present sufficient evidence that Defendants’ proposed product has two distinct formulations, as required by each asserted claim. 

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