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S. 1040 · Where this bill is now

In committee

Introduced in the Senate, Mar 13, 2025

What this bill does

In plain words · AI-written from the official summary

Stops drug makers from blocking generic competition

Ever wondered why some drug makers switch to a slightly different version of a drug right when cheaper generic versions are about to hit the market. This bill makes that practice illegal. It says drug manufacturers can't use patents on new versions to dodge competition from generic drugs, and it gives the Federal Trade Commission power to punish companies that do this and recover money for people who were harmed.

How it affects you

If you take prescription drugs, this could eventually mean lower prices. When generic versions can actually reach the market without manufacturers blocking them with patent tricks, competition increases and drug costs typically fall. Patients and insurance companies that pay for medications would directly benefit from this lower-cost competition.

Read the official summary (Introduced in Senate, Mar 13, 2025)

Drug Competition Enhancement Act

This bill prohibits product hopping by drug manufacturers and authorizes the Federal Trade Commission (FTC) to enforce this prohibition.

Generally, product hopping describes a situation where, when the patents on a reference drug (or biological product) expire, the manufacturer switches to a follow-on product that is covered by a later-expiring patent. Under this bill, a follow-on product is a modified version of the reference drug that has an indication (what the drug is used for) that is identical or substantively similar to an indication of the reference drug.

The bill establishes a presumption that product hopping has occurred when a reference drug manufacturer, after receiving notice that the Food and Drug Administration has received an application to market a competing generic (or biosimilar) version, takes certain actions such as withdrawing the reference drug from the market and selling a follow-on product.

A drug manufacturer may rebut these presumptions by demonstrating that its conduct was not intended to limit competition.

The bill makes product hopping an unfair method of competition and provides for enforcement by the FTC. If the FTC has reason to believe a manufacturer has violated or is about to violate this prohibition on product hopping, the FTC may institute an administrative proceeding or bring suit in federal court to stop the manufacturer’s action and seek equitable remedies, including disgorgement of unjust profits or paying restitution to those harmed.

Written by AI (Claude) using only the official summary by the Congressional Research Service, the Library of Congress’s nonpartisan research staff. It can miss nuance, so check the official summary and the bill text for details.

119th Congress
1st Session
S. 1040

A BILL

Drug Competition Enhancement Act

In the SenateNo vote yet

Sponsor: Sen. John Cornyn (R-TX) · Introduced Mar 13, 2025 · Health · 2 versions of the text

Sources: Congress.gov actions and votes · bill text from GovInfo · latest official action Apr 10, 2025: “Placed on Senate Legislative Calendar under General Orders. Calendar No. 43.”

Sections

Opens on the most recent version where something changed
Sections · 1
S. 1040: Drug Competition Enhancement Act — Bill Status, Votes and Text · Public Law Tracker