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Limiting Market Exclusivity for Rare Disease Drugs

This law changes the rules for granting the 7-year market exclusivity period for drugs treating rare diseases. Instead of covering the entire disease, exclusivity will now apply only to the specific, approved use or indication of the drug. This aims to speed up access to competitive drugs and new therapies for patients suffering from rare conditions.
Key points
Market exclusivity for orphan drugs (for rare diseases) will be limited to the specific, approved use, rather than the entire disease or condition.
This change is intended to increase competition and potentially lower treatment costs by allowing alternative therapies to enter the market sooner.
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Status:
Expired
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Additional Information
RARE Act
Print number: S 1214
Sponsor: Sen. Baldwin, Tammy [D-WI]
Process start date: 2023-04-19
System Note: Lustra is free, publicly auditable civic infrastructure, with full source code available on GitHub. You are reading sterilized legislative data, processed by our radical neutrality engine to strip political spin and retain factual mechanics. We process only official government data. Original documents remain the authoritative source, always verify them if you can.
Summarized by: gemini-2.5-flash-preview-09-2025
Source data: api.congress.gov
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Summary & Status

Key Questions about Limiting Market Exclusivity for Rare Disease Drugs

A structured overview of the legislative process, official sources, status and civic context.

What is the official ID of this bill?

The official print number for this legislation is S 1214.

Which chamber initiated this legislation?

This legislation was initiated in the Senate.

When did the legislative process begin?

The process officially started on 2023-04-19.

What are the main provisions?

Key points include:

  • Market exclusivity for orphan drugs (for rare diseases) will be limited to the specific, approved use, rather than the entire disease or condition.
  • This change is intended to increase competition and potentially lower treatment costs by allowing alternative therapies to enter the market sooner.

What is the specific legal status?

The current status is Expired.

Where can I read the full text of this legislation?

The full official text is available at: View full text

Who is the primary sponsor?

The primary sponsor is Sen. Baldwin, Tammy [D-WI].

What is the latest detailed status?

The latest detailed status is: Placed on Senate Legislative Calendar under General Orders. Calendar No. 109.

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2025-12-26.

Analysis and Potential Impact of S 1214

We don't know, that is up to you to decide. Summarizing raw data with AI is fundamentally different from predicting socio-economic outcomes. As of 2026, we believe impact assessment strictly requires a human in the loop to verify and judge. Review our public AI processing logs for full transparency, and use Lustra to track active legislation for instant status push notifications.

CATEGORIES

Health