Priority Review Voucher Sales and FDA Awards

• Rare pediatric disease. FDA may award vouchers until September 30, 2029, under Public Law 119-75 (signed February 3, 2026). FDA's program page says the same.
• Tropical disease. Section 524 of the FD&C Act carries no end date. FDA keeps the qualifying disease list. Its latest docket decision, on May 22, 2026, was not to add hepatitis delta.
• Material threat medical countermeasure. Section 565A(g) says FDA may not award these vouchers after October 1, 2023 (the Act as amended through Public Law 119-75). FDA still published notices for Paxlovid in May 2024 and Ebanga in April 2025, and they give no award date.
• Using one. The fiscal year 2027 fee is $1,798,596 (Federal Register, September 10, 2026).

A sale is listed only when the seller's press release, an SEC filing or FDA's own record states the price. A sale reported only by a news outlet is left out, so the list is not complete. The date is when the earliest source listed disclosed the sale, which can be after the agreement was signed; a note says when the source gives an earlier date. Prices are gross, before fees and any share owed to a licensor or institute, and a note on the row says when the seller kept only part. The buyer is blank when the source does not name one.

FDA publishes a Federal Register notice for each rare pediatric disease and material threat voucher it awards, and the awards table is read from those notices. FDA does not publish tropical disease awards or say which vouchers have been used, so neither is shown. FDA's Commissioner's National Priority Vouchers are a separate pilot and are not covered.

The notices refresh daily from the Federal Register. A daily check of SEC filings queues possible new sales for a person to verify. A queued filing never appears on this page until its price has been checked against the source.

• Sales that were disclosed outside SEC filings and sponsor releases this page could reach, such as some sellers outside the United States. They are missing rather than guessed.
• Which vouchers have been used, and by whom. FDA does not publish it.
• Whether FDA's material threat notices for 2024 and 2025 reflect awards made after the October 1, 2023 sunset. The notices give no award date.
• The buyer in rows marked not disclosed. Some filings call the buyer an affiliate of a large pharmaceutical company without naming it.

How much does a priority review voucher sell for?

The median of the 10 most recent disclosed sales is $197.5 million. Disclosed prices run from $21.1 million to $350 million across the 39 sales listed here, each with a source link. Prices are gross, as the seller reported them.

Is the rare pediatric disease priority review voucher program still running?

Yes. Public Law 119-75, the Consolidated Appropriations Act, 2026, enacted February 3, 2026, amended section 529 of the FD&C Act so that FDA may not award rare pediatric disease vouchers after September 30, 2029. FDA's program page says the same.

What does it cost to use a priority review voucher?

FDA's fiscal year 2027 priority review user fee is $1,798,596, set in a Federal Register notice of September 10, 2026. It applies to tropical disease, rare pediatric disease and material threat medical countermeasure vouchers and is due in addition to the application fee.

Does FDA publish who bought a voucher?

No. FDA publishes a Federal Register notice when it awards a rare pediatric disease or material threat voucher. A sale is a private transaction, so prices and buyers come from the seller's press release or SEC filing, and some sales are never disclosed.

How is this list kept current?

The list of vouchers FDA has announced is re-read from the Federal Register every day. SEC filings are checked every day for possible new sales, which are queued for a person to verify against the source. A queued filing is never shown on this page.