FTC Continues Battle to Force Teva to Delist Patents From Orange Book

March 27, 2024

The FTC has filed an amicus brief in a suit between Teva Pharmaceuticals and Amneal Pharmaceuticals, supporting Amneal and saying Teva has improperly listed the patents in dispute in the FDA’s Orange Book, and urged the court to order Teva’s listings removed.

Teva brought the case against Amneal after Amneal sought FDA approval to bring a generic version of asthma inhaler ProAir HFA to market, delaying market entry of Amneal’s less expensive generic inhaler devices.

Teva argued that Amneal’s patents infringe on Teva’s ProAir HFA patents and had listed them in the FDA’s publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the “Orange Book.” Teva’s patent infringement claims triggered a statutory stay that blocks approval of Amneal’s competing drug product for up to 30 months — potentially until February 2026.

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