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Senate bill · S. 43 (119th Congress)

Skinny Labels, Big Savings Act

U.S. Senate

Latest action Jan 9, 2025

Sponsor: John W. Hickenlooper (U.S. Senator for Colorado, Democratic)

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From Congress.gov and official rosters. This record was last updated Jul 30, 2026. About our data

Summary

Skinny Labels, Big Savings Act This bill provides a statutory safe harbor from patent infringement claims for generic or biosimilar manufacturers that seek or obtain approval for skinny labels of their drugs. Under current law, the Food and Drug Administration (FDA) may approve generic and biosimilar drugs through a process known as skinny labeling, which allows a generic manufacturer to seek approval only for approved uses of the drug that are no longer protected by patents. However, in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. , a court held that a generic manufacturer may sometimes be liable for patent infringement when it markets skinny label generics. The bill specifically lists the following as actions that are not considered infringement of a method of use claim in a patent under the Federal Food, Drug, and Cosmetic Act: submitting or seeking approval of a skinny label for a generic or biosimilar drug; promoting or commercially marketing a drug with skinny labeling approved by the FDA; or describing a drug product approved by the FDA as a generic of, or therapeutically equivalent to, the branded drug. The bill also applies the safe harbor to similar actions under the Public Health Service Act.

Summary from the Congressional Research Service. How we handle summaries

Where it stands

Assigned to a committee for review.

  1. Introduced
  2. In committee
  3. Up for a vote
  4. Passed one chamber
  5. Passed
  6. Enacted

Committee

House Committee on the Judiciary · U.S. House of Representatives

Also referred to Senate Committee on the Judiciary · U.S. Senate.

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Cosponsors

3

Cosponsors listed on Congress.gov, shown A to Z.

  • Republican2
  • Democratic1

This bill has cosponsors from more than one party.

Shown in neutral colors by design; Agora is non-partisan.

Related bills

As identified by Congress.gov.

Full history

  1. Jan 9, 2025

    Introduced

    Introduced in U.S. Senate

    U.S. Senate

  2. Jan 9, 2025

    Referred to committee

    Read twice and referred to the Committee on the Judiciary.

  3. Jan 9, 2025

    Referred to committee

    Read twice and referred to the Committee on the Judiciary.

  4. Jan 9, 2025

    Referred to committee

    Read twice and referred to the Committee on the Judiciary.

Read the record