Judge Orders Teva to Remove ProAir HFA Device Patents From Orange Book

A New Jersey federal judge has ordered Teva Pharmaceuticals to remove from the Orange Book five patents on its ProAir HFA asthma inhalation device, clearing the way for Amneal Pharmaceuticals to launch a generic version.

The decision is the latest in an ongoing battle between Amneal and Teva, and related to a larger action the FTC has undertaken to remove improperly listed patents that are blocking market entrance for generic products. Earlier this year, three of the 10 companies warned of inappropriate Orange Book patent listings agreed to delist the challenged patents; five others — including Teva — refused.

The Teva case originated when Amneal sought FDA approval to bring a generic version of ProAir HFA to market. Teva’s patent infringement claims triggered a statutory stay that blocked approval of Amneal’s competing drug product for up to 30 months — potentially until February 2026. In March, the FTC entered the fray with an amicus brief supporting Amneal.

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