A 2289 New York Assembly · 2025 Regular Session

Enacts the manufacturer disclosure and transparency act

Summary

Enacts the manufacturer disclosure and transparency act requiring prescription drug manufacturers to notify the attorney general of arrangements between pharmaceutical manufacturers resulting in the delay of the introduction of generic medications.

Issues: ✓ Healthcare

Bill status in committee 1 of 4 stages cleared

Introduction

Jan 2025

Committee Review

Floor Vote

Governor

Introduced Jan 16, 2025 Last action Jan 7, 2026

Maddy AI version diff · 1 comparison

What changed between versions

A2289 → A2289A · 4 edits

MODERATE

The bill was amended to expand its scope from only requiring notice of generic drug delays to also requiring notice of patent settlement agreements. It added detailed definitions for terms like 'patent settlement agreement' and 'biological product,' and increased the daily penalty for non-compliance from $5,000 to $10,000.

Scope change

The bill now applies to both brand-name drug manufacturers delaying generic entry and those entering into patent settlement agreements that affect commercial launch dates, including those involving biosimilars.

SCOPE

Added a new requirement for pharmaceutical manufacturers to notify the Attorney General when entering into patent settlement agreements that affect the commercial launch date of a drug or biological product.

DEFINITION

Introduced specific definitions for key terms including 'patent settlement agreement,' 'biological product,' 'biosimilar,' 'interchangeable product,' and 'reference product sponsor' to clarify the bill's application.

ENFORCEMENT

Increased the daily fine for failing to submit the required notice from $5,000 to $10,000.

REQUIREMENT

Required the Attorney General to post the full text of patent settlement agreements on their website for public review within 60 days of receiving notice.

Floor votes

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No floor votes recorded yet.

Full legislative history

Actions timeline

Total actions

Key actions

Committee

Amendments

Jan 7, 2026

Committee

REFERRED TO CONSUMER AFFAIRS AND PROTECTION

lower

May 22, 2025

Lower · Passed

PRINT NUMBER 2289A

lower

May 22, 2025

Lower · Passed

AMEND AND RECOMMIT TO CONSUMER AFFAIRS AND PROTECTION

lower

Jan 16, 2025

Committee

REFERRED TO CONSUMER AFFAIRS AND PROTECTION

lower

1 primary · 27 co-sponsors