As part of efforts to increase transparency and generic drug competition, the US Food and Drug Administration (FDA) is publishing patent submission dates to help generic drug manufacturers determine ...

The Federal Circuit heard oral argument on November 8, 2024, grappling with the issue of what patent claims may properly be listed in the Orange Book. In late 2023, Teva filed a complaint for patent ...

The US Food and Drug Administration has published a final draft guidance that addresses what’s expected when sponsors get complete response letters (CRL) to their abbreviated new drug applications ...

The Federal Trade Commission announced on Wednesday that Teva Pharmaceutical (TEVA), under pressure from the agency, has requested the removal of more than 200 patents improperly listed in the FDA’s ...

For more than two years, the U.S. Federal Trade Commission (FTC) has been taking certain drugmakers to task over their alleged listing of "improper" patents in an FDA registry, a practice the agency ...

Biofrontera Inc. announced that it has received patent approval for a revised formulation of its Ameluz® nanoemulsion gel, which is now listed in the FDA's Orange Book, ensuring patent protection ...