Had Teva not challenged Amneal on the basis of its five ProAir HFA patents, Amneal argues that the FDA could have approved its generic asthma med as early as April 2024, according to the FTC.

Use your preventer inhaler as prescribed, even if your asthma feels under control and the blue inhaler is rarely or never needed. Without regular use of a preventer inhaler, symptoms could worsen ...

The report said that U.S. District Judge Stanley Chesler agreed with Amneal and the FTC, that Teva's patents only covered inhaler device technology, ordering it to remove the listings from the FDA ...

Teva Pharmaceuticals failed to convince a U.S. appeals court on Friday to reverse a decision that would remove patents related to its ProAir HFA inhaler from the U.S. Food and Drug Administration ...

In October 2023, Teva Pharmaceuticals filed a patent infringement lawsuit against Amneal Pharmaceuticals alleging that their generic version of Teva’s ProAir® HFA inhaler infringed upon the ...

Teva stopped making brand-name ProAir HFA in October 2022, though the company continues to offer an authorized generic. Amneal did not immediately respond to Fierce Pharma’s request for comment.

The case is centered around Teva’s New Drug Application (NDA) for the ProAir HFA inhaler. While Teva holds patents related to the inhaler, a product that is used to treat potentially life ...

R&D, Inc. v. Amneal Pharms. of N.Y., LLC, affirming a lower court decision that Teva must delist five patents from the US Food and Drug Administration (FDA) Orange Book that claim inhalers for ...

Amneal, US FTC win order removing Teva inhaler patents from FDA list By Blake Brittain June 10, 20243:26 PM PDTUpdated June 10, 2024 ...