# 119-s-43: Skinny Labels, Big Savings Act

119-s-43, Skinny Labels, Big Savings Act, is a 119th Congress bill sponsored by Sen. Hickenlooper, John W. [D-CO] (D-CO); status introduced; PRIA reads it as touching household money (as of 2026-08-11).

- Canonical: https://policyrisk.com/legislation/119-s-43
- As of: 2026-08-11
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Bill: 119-s-43
- Congress: 119
- Title: Skinny Labels, Big Savings Act
- Status: introduced
- Introduced: 2025-01-09
- Sponsor: Sen. Hickenlooper, John W. [D-CO] (D-CO)
- Cosponsors: 3
- Policy area: Commerce
- Touches household money: yes
- Last recorded action: 2026-08-11

## Summary

**Creates a statutory safe harbor for skinny-labeled generics and biosimilars.** The bill says seeking FDA approval, marketing, or describing a product as generic or biosimilar with FDA-approved skinny labeling will not count as infringement of method-of-use patents under the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act, subject to limits tied to what patent owners have told the FDA about patented uses. - Generic and biosimilar manufacturers can submit or seek approval and market products with skinny labeling without facing direct, induced, or contributory infringement claims for method-of-use patents when done in connection with FDA approval pathways such as 505(j) or 351(k). - Brand patent owners lose the ability to sue over those specific activities when the safe harbor applies, but the protection does not cover labeling, promotion, or marketing that references the patented condition the patent owner identified to the FDA. - The safe harbor covers conduct that occurred before, on, or after enactment and applies to judicial or other proceedings that are pending.

## Cosponsors (3)

- Sen. Welch, Peter [D-VT] (D-VT), 2025-01-09T00:00:00.000Z
- Sen. Cotton, Tom [R-AR] (R-AR), 2025-01-09T00:00:00.000Z
- Sen. Collins, Susan M. [R-ME] (R-ME), 2025-01-09T00:00:00.000Z

## Provisions PRIA read

- New patent safe harbor for generic drugs: benefit, medium. This bill would create a safe harbor for method-of-use patents tied to listed drug products. If you file an ANDA, a 505(b)(2), or a related animal-drug filing, submitting the application, using the proposed labeling, marketing with that labeling, or calling the product generic or therapeutically eq…
- New safe harbor for biosimilars: benefit, medium. This bill would create a safe harbor for method-of-use patents tied to reference biological products. If you file a 351(k) biosimilar or interchangeable application, submitting the application, describing the product as biosimilar or interchangeable using the approved labeling, or marketing the pro…
- Definitions and retroactive safe harbor: benefit, low. This bill would adopt standard definitions for words used in the safe harbors, relying on existing FDA and PHSA definitions for terms like "biosimilar," "labeling," and "commercial marketing." It would also make the new safe-harbor rules apply to conduct before, on, or after enactment and to pendin…

## Related bills

- 119-s-1748: Kids Online Safety Act
- 119-s-3923: Weather Research and Forecasting Innovation Reauthorization Act of 2026
- 119-s-1241: Sanctioning Russia Act of 2025
- 119-s-410: Love Lives On Act of 2025
- 119-s-1261: CONNECT for Health Act of 2025
- 119-s-1462: Fix Our Forests Act

## Sources
- [119-s-43 on Congress.gov](https://www.congress.gov/bill/119th-congress/senate-bill/43)

## Related
- [119-s-1748: Kids Online Safety Act](https://policyrisk.com/legislation/119-s-1748)
- [119-s-3923: Weather Research and Forecasting Innovation Reauthorization Act of 2026](https://policyrisk.com/legislation/119-s-3923)
- [119-s-1241: Sanctioning Russia Act of 2025](https://policyrisk.com/legislation/119-s-1241)
- [119-s-410: Love Lives On Act of 2025](https://policyrisk.com/legislation/119-s-410)
- [119-s-1261: CONNECT for Health Act of 2025](https://policyrisk.com/legislation/119-s-1261)
- [119-s-1462: Fix Our Forests Act](https://policyrisk.com/legislation/119-s-1462)
- [All bills in Congress](https://policyrisk.com/legislation)

Source: PRIA, https://policyrisk.com/legislation/119-s-43 (as of 2026-08-11).