S 1128 United States Senate · 118th Congress

Ensuring Access to Generic Medications Act

This bill creates a legal process allowing generic drug manufacturers to challenge inaccurate patent listings by brand-name drug companies. Specifically, it permits generic applicants to file lawsuits seeking court orders to correct or delete misleading "use codes" in patent records related to a drug's method of use. This directly affects generic drug makers and brand-name sponsors who list patents for drug applications under FDA approval pathways. The key mechanism requires courts to address listings that don't match actual patents, cover unrelated uses, or are overly broad, aiming to clear patent-related barriers for generic competition.
Sub-Topics: Prescription Drugs
Bill status in committee 1 of 4 stages cleared
Introduction
Mar 2023
Committee Review
Floor Vote
President
Introduced Mar 30, 2023 Last action Mar 30, 2023
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Total actions
2
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0
Committee
1
Mar 30, 2023
Committee
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
upper
Mar 30, 2023
Introduced
Introduced in Senate
upper
1 primary · 2 co-sponsors

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