Skip to main content
S 142 118th Congress Senate Health Administrative law and regulatory procedures Civil actions and liability Competition and antitrust Contracts and agency Federal Trade Commission (FTC) Intellectual property Judicial review and appeals Licensing and registrations Manufacturing Marketing and advertising Prescription drugs

Preserve Access to Affordable Generics and Biosimilars Act

Introduced: January 30, 2023 Introduced by: Klobuchar, Amy Democratic · Minnesota See on congress.gov
Sign in to write a letter Sign in to watch
This bill died when the 118th Congress ended
It never became law before the 118th Congress (2023–2024) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 5 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Mar 1, 2023
Placed on Senate Legislative Calendar under General Orders. Calendar No. 20.
Mar 1, 2023
Committee on the Judiciary. Reported by Senator Durbin with an amendment in the nature of a substitute. Without written report.
Feb 9, 2023
Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.
Jan 30, 2023
Read twice and referred to the Committee on the Judiciary.
Jan 30, 2023
Introduced in Senate
 Ask about this bill AI · grounded in the bill text

Have a question about what this bill does? Ask in plain English; the answer is drawn from the bill's actual text and official record, and it'll tell you when something isn't in the text rather than guess.

AI answers can be imperfect; always confirm against the full bill text.

 Plain-English summary Congressional Research Service

Preserve Access to Affordable Generics and Biosimilars Act

This bill authorizes the Federal Trade Commission (FTC) to initiate proceedings against parties to any agreement resolving or settling a patent infringement claim in connection with the sale of a drug or biological product. Such an agreement is presumed to have anticompetitive effects and is a violation of this bill if the filer of the generic drug or biosimilar application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug or biosimilar.

An agreement is exempted if the only consideration granted to the generic manufacturer is (1) the right to market and secure final approval for its product prior to the expiration of any statutory exclusivity, (2) a payment for reasonable litigation expenses, or (3) a covenant not to sue on any claim that the generic drug or biosimilar infringes a patent. An agreement is also exempt if the agreement's pro-competitive benefits outweigh the anticompetitive effects.

When a generic or biosimilar drug manufacturer enters into an agreement with another drug manufacturer related to the manufacturing, marketing, or sale of a drug, the manufacturers must certify that the material they have given the FTC concerning the agreement contains the complete agreement and any agreements related to that main agreement, including descriptions of any oral agreements or representations.

The bill imposes penalties for violations of this bill, including the forfeiture of the 180-day marketing exclusivity period for a generic drug.

What's happening now March 1, 2023

Placed on Senate Legislative Calendar under General Orders. Calendar No. 20.

 Bill text 2 versions

Source documents hosted by congress.gov.

 Committees of jurisdiction 1
 Lobbying activity 9

Registered lobbyists who named this bill in their disclosure filings. Source: federal Lobbying Disclosure Act filings.

See all 9 filings →
 Cosponsors 10
All 10 Democratic 7 Republican 3
D
Welch, Peter
Vermont · Feb 9, 2023
 R
Ernst, Joni
Iowa · Feb 1, 2023
 D
Ossoff, Jon
Georgia · Feb 1, 2023
 D
Blumenthal, Richard
Connecticut · Jan 30, 2023
 D
Booker, Cory A.
New Jersey · Jan 30, 2023
 R
Cramer, Kevin
North Dakota · Jan 30, 2023
 D
Durbin, Richard J.
Illinois · Jan 30, 2023
 R
Grassley, Chuck
Iowa · Jan 30, 2023
 D
Kelly, Mark
Arizona · Jan 30, 2023
 D
Van Hollen, Chris
Maryland · Jan 30, 2023
Cite this page click to expand
APA
U.S. Congress. (2026). S. 142: Preserve Access to Affordable Generics and Biosimilars Act. 118th Congress. Open America. https://openamerica.io/bill/118-S-142/
MLA
"S. 142: Preserve Access to Affordable Generics and Biosimilars Act." 118th Congress, 2026, Open America, https://openamerica.io/bill/118-S-142/.
Bluebook (legal)
S. 142, 118th Cong. (2026), https://openamerica.io/bill/118-S-142/.
Markdown link
[S. 142: Preserve Access to Affordable Generics and Biosimilars Act](https://openamerica.io/bill/118-S-142/)
Report a problem