S 43
Skinny Labels, Big Savings Act
Jurisdiction
US Congress
Session
119th Congress (2025-2026)
Last updated at
Jun 14, 2026, 8:40 AM
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Sign in to take action- Introduced
- Passed Senate
- Passed House
- To President
- Became Law
Bill overview
The Skinny Labels, Big Savings Act aims to protect generic and biosimilar drug manufacturers from patent infringement lawsuits. Specifically, it establishes a ‘safe harbor’ that shields manufacturers who obtain FDA approval for drugs labeled with only the approved uses of a drug, as opposed to all uses covered by a patent. This legislation clarifies that certain actions, such as submitting an application for approval, promoting a drug with approved labeling, or describing a drug as generic, do not constitute infringement, provided certain conditions are met regarding reference to patented conditions of use.
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