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Support for Rare Disease Drugs: COVID-19 Exclusivity Extension

Leo's Law aims to support pharmaceutical companies in developing drugs for rare diseases that were impacted by the COVID-19 pandemic. It extends market exclusivity periods for these drugs, which may encourage further research and development, potentially accelerating access to new therapies for patients with rare conditions.
Key points
Extends market exclusivity periods by 180 days for orphan drugs whose development was hindered by the COVID-19 pandemic.
Applies to drugs for which applications were submitted during the COVID-19 emergency period and are exclusively for rare diseases.
The goal is to incentivize companies to continue research and bring drugs to market for patients with rare conditions, who often have limited treatment options.
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Additional Information
Print number: 118_HR_1805
Sponsor: Rep. Gottheimer, Josh [D-NJ-5]
Process start date: 2023-03-27
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Summarized by: gemini-2.5-flash-preview-05-20
Source data: api.congress.gov
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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 118_HR_1805.

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 2023-03-27.

What are the main provisions?

Key points include:

  • Extends market exclusivity periods by 180 days for orphan drugs whose development was hindered by the COVID-19 pandemic.
  • Applies to drugs for which applications were submitted during the COVID-19 emergency period and are exclusively for rare diseases.
  • The goal is to incentivize companies to continue research and bring drugs to market for patients with rare conditions, who often have limited treatment options.
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 Rep. Gottheimer, Josh [D-NJ-5].

What is the latest detailed status?

The latest detailed status is: Referred to the Subcommittee on Health.

Is this summary verified?

Yes. This content was analyzed by AI and verified by the Lustra Judge System on 2025-12-24.

CATEGORIES

Health