HR. 6485In Committee

Skinny Labels, Big Savings Act

Establishes a patent infringement safe harbor for generic and biosimilar drug makers using FDA-approved skinny labels for unpatented uses

What this bill does

Establishes a patent infringement safe harbor for generic and biosimilar drug makers using FDA-approved skinny labels for unpatented uses

Key points
  • Establish patent safe harbor
  • Authorize skinny label approval actions
  • Allow marketing of skinny label drugs

Where it stands

Status
In Committee
Latest action
2025-12-05Referred to the House Committee on the Judiciary.

Topics and policy areas

undefinedCommerce