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Leo's Law: Extending Market Protection for Rare Disease Treatments

This bill extends market exclusivity for drugs treating rare diseases by 180 days to offset development delays caused by the COVID-19 pandemic. It aims to maintain incentives for companies to create treatments for conditions that affect few people.
Key points
Adds 180 days to the period during which a drug has no competition from generic versions.
Applies to 'orphan drugs' developed or submitted during the COVID-19 emergency period.
Helps ensure that research into rare diseases remains financially viable despite pandemic disruptions.
May result in a 6-month delay before cheaper generic alternatives become available to patients.
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Status:
Introduced
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Additional Information
Print number: 119_HR_7693
Sponsor: Rep. Gottheimer, Josh [D-NJ-5]
Process start date: 2026-02-25
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-flash-latest
Source data: api.congress.gov
AI work logs for this document launch

OFFICIAL LEGAL TITLE

Leo’s Law

FREQUENTLY ASKED QUESTIONS

What is the official ID of this bill?

The official print number for this legislation is 119_HR_7693.

Which chamber initiated this legislation?

This legislation was initiated in the House of Representatives.

When did the legislative process begin?

The process officially started on 2026-02-25.

What are the main provisions?

Key points include:

  • Adds 180 days to the period during which a drug has no competition from generic versions.
  • Applies to 'orphan drugs' developed or submitted during the COVID-19 emergency period.
  • Helps ensure that research into rare diseases remains financially viable despite pandemic disruptions.
  • May result in a 6-month delay before cheaper generic alternatives become available to patients.
What is the specific legal status?

The current status is Introduced.

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 Rep. Gottheimer, Josh [D-NJ-5].

What is the latest detailed status?

The latest detailed status is: Referred to the House Committee on Energy and Commerce.

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2026-03-13.

What is the impact of this bill?

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.

CATEGORIES

Health Economy