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www.fdanews.com/articles/165345-teva-reaches-patent-settlement-with-perrigo-and-catalent-over-proair-hfa

Teva Reaches Patent Settlement with Perrigo and Catalent Over ProAir HFA

June 20, 2014

Teva said it had reached a settlement with Perrigo Pharmaceutical and Catalent Pharma Solutions that will allow the companies to sell generic versions of Teva’s ProAir HFA Inhalation Aerosol product ahead of patent expiry.

This settlement provides a license to market limited quantities of the product from Dec. 19, 2016, through June 2018, when the limits will no longer apply, Teva said Friday. This agreement dismisses pending litigation in the U.S. District Court for the District of Delaware, in which Teva filed suit against Perrigo and Catalent following their challenge to four of the five patents on the drug.

The drug is indicated in patients four years of age and older for the treatment of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.

Teva said there are no additional generic challenges to the ProAir HFA and no further litigation pending. — Neal Learner

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