This settlement provides a license to Perrigo and Catalent to sell limited units of Perrigo’s generic version of the product for an initial period beginning Dec. 19, 2016 and lasting until June 2018, when the limits will no longer apply.
This settlement dismisses pending litigation in the U.S. District Court for the District of Delaware in which Teva filed suit against Perrigo and Catalent in response to a notice of the filing of an ANDA containing a paragraph (IV) certification directed against four (4) of the five (5) patents listed in the Orange Book for ProAir HFA (U.S. Patent 7,105,152, which expires September 12, 2023; 7,566,445, which expires June 4, 2017; 6,446,627, which expires December 18, 2017; and 8,132,712, which expires September 7, 2028.) Additional terms of the settlement are agreed by the parties to remain undisclosed.
There are currently no additional challenges to the IP for ProAir HFA and no further litigation pending. Teva will continue to vigorously defend its intellectual property rights relating to its products.
ProAir HFA is indicated in patients 4 years of age and older for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm.