Guaifenesin & combinations - USA

On Sep. 10, 2018 Federal Circuit affirmed (Rule 36 judgment) district court’s decision of non-infringement in Mucinex®; Mucinex-D®; Mucinex DM®.

District court’s decisions:

Mucinex®; Mucinex-D® - On Aug 22, 2017, the New Jersey District Court issued its opinion in a case involving Amneal and Dr. Reddy’s and their formulations involving Mucinex®(guaifenesin) (Amneal) and Mucinex D®(guaifenesin and pseudoephedrine) ER Tablets (Dr. Reddy’s). The trial had ended in May, and essentially, the two patents (6,955,821 and 7,838,032) covered the product’s two-release formulation. In concluding neither ANDA filer infringed these patents, Judge Bumb found that each of their formulation is single formulation matrices. This ruling follows similar rulings made over the years in different jurisdictions over the Mucinex® family of products.

Mucinex DM® (guaifenesin & dextromethorphan) - On Mar 6, 2017 the Delaware District Court granted summary judgment to Aurobindo. Judge Stark concluded that the facts were relatively clear that the two patents ('821 and '032) covered a product that included both an immediate-release formulation and a sustained-release formulation. There was no evidence that the Aurobindo formulation had the two components. Thus, the Court granted summary judgment to Aurobindo, finding non-infringement.