Preserve Access to Affordable Generics and Biosimilars Act

openUnited States· United States Congress· EN

Introduced

28 April 2021

Last action

9 December 2021 · Reported

Status

Placed on Senate Legislative Calendar under General Orders. Calendar No. 180.

Summary

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 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.

This text is taken from the official record. PoliticalRepo does not editorialize.

Timeline

28 April 2021
Introduced
Read twice and referred to the Committee on the Judiciary.
Source: IntroReferral
28 April 2021
Introduced
Introduced in Senate
Source: IntroReferral
29 July 2021
Reported
Committee on the Judiciary. Ordered to be reported with an amendment in the nature of a substitute favorably.
Source: Committee
9 December 2021
Calendars
Placed on Senate Legislative Calendar under General Orders. Calendar No. 180.
Source: Calendars
9 December 2021
Reported
Committee on the Judiciary. Reported by Senator Durbin with an amendment in the nature of a substitute. Without written report.
Source: Committee
9 December 2021
Reported
Committee on the Judiciary. Reported by Senator Durbin with an amendment in the nature of a substitute. Without written report.
Source: Committee

Votes

No vote records are attached yet.

Versions

Reported to Senate · 9 December 2021 · Download file
Introduced in Senate · 28 April 2021 · Download file

Documents

6 official files

Reported to Senate (text)

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Reported to Senate (text)
Reported to Senate · EN · 9 December 2021
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Reported to Senate (PDF)
Reported to Senate · EN · 9 December 2021
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Reported to Senate
summary · EN · 9 December 2021
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Introduced in Senate (text)
Introduced in Senate · EN · 28 April 2021
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Introduced in Senate (PDF)
Introduced in Senate · EN · 28 April 2021
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Introduced in Senate
summary · EN · 28 April 2021
Open at official source
Leesvertaling
Vertaal dit document naar jouw taal. PoliticalRepo bewaart geen aparte kopie per EU-taal.
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Documentvertaling op verzoek met downloadbare PDF (logo + link naar de officiële bron). Het bronbestand blijft leidend.

Related records

related to → Preserve Access to Affordable Generics and Biosimilars Act
related to ← Reduced Costs and Continued Cures Act of 2021
related to ← Reduced Costs and Continued Cures Act
related to ← Preserve Access to Affordable Generics and Biosimilars Act

Sources

PoliticalRepo is an index and interpretation layer, not the authoritative legal source.

Official source: https://www.congress.gov/bill/117th-congress/senate-bill/1428
Open data entity: https://api.congress.gov/v3/bill/117/s/1428
us · 117-s-1428 · source updated 10 August 2026