Meridian Medical Technologies, a Pfizer subsidiary, and Teva have entered into a settlement agreement to resolve generic epinephrine auto-injector pending patent litigation.
Under the terms of the agreement, Teva may launch a generic epinephrine auto-injector covered by its ANDA on 22 June 2015 or earlier under certain circumstances, subject to receipt of approval from the FDA. Additional terms of the agreement, which is subject to review by the US Department of Justice and the Federal Trade Commission, have not been disclosed. Teva presently does not have tentative FDA approval for its epinephrine auto-injector product. Meridian manufactures EpiPen Auto-Injector while Mylan Specialty markets and distributes the product in the US.
