PRV Tracker

About PRVs
While most drugs are funded and developed by the pharmaceutical industry, those for rare diseases can sometimes fall outside that model. For conditions affecting very small patient populations, developing a treatment is often not commercially viable due to high costs and long timelines. To address this market failure, Congress established the Priority Review Voucher (PRV) framework in 2007 for tropical diseases, later expanding to rare pediatric diseases and material threat medical countermeasures.

PRVs are awarded to sponsors that receive approval for drugs targeting the qualifying indications mentioned above. Sponsors that receive a PRV can either redeem it to shorten FDA’s target review timeline from the standard 10 months to 6 months for a drug application or sell it to another sponsor. Because faster FDA review can allow a drug to reach the market earlier, many sponsors consider PRVs highly valuable.

For more background on the PRV program design, sunset dates, and program impact, see The Butterfly Effect: How Pediatric PRVs Shape Innovation and Access to Medicines.

What the Data Shows
To date, a total of 96 PRVs have been awarded across the Tropical Disease (TD), Rare Pediatric Disease (RPD), and Material Threat Medical Countermeasures (MTMC) programs. Rare Pediatric Disease PRVs account for 71 of those awards, or roughly three-quarters of all PRVs awarded.

The following stacked bar chart illustrates the number of PRVs awarded each year. PRV awards generally trended upward from 2009 to 2023, peaking at 13 awards in 2023.

To date, publicly disclosed PRV sales have generated more than $5.7 billion, including $4.7 billion from Rare Pediatric Disease PRV sales alone. These transactions can provide crucial funding for biotech companies to sustain their pipelines. The following pie chart shows the total PRV sales by disease type. RPD vouchers account for 83% of all PRVs sold.

Among publicly disclosed PRV sales, prices varied. The highest disclosed sale price was $350 million for the PRV awarded to United Therapeutics for Unituxin in 2015, while the lowest disclosed sale price was $67.5 million for the PRV awarded to BioMarin for Vimizim in 2014. The following table and boxplot provide more descriptive statistics on PRV sale prices.

Overall, sale prices were relatively steady from 2016 to 2024, generally falling within the $80–$150 million range. From 2024 to 2026, sale prices rose, with most transactions exceeding $150 million and some surpassing $200 million. This suggests that PRVs are becoming more valuable, likely because of strong demand for faster FDA review and the limited supply of vouchers available for sale.

The following chart shows how PRV sale prices have changed over time. Each point represents a transaction, and hovering over a point reveals more information about each sale.

Conclusion
Since its launch, the PRV program has become an important tool for the rare disease community, providing companies with a crucial financial incentive to sustain investments in rare disease pipelines. Across all voucher programs, the Rare Pediatric Disease PRV program has been the most impactful, accounting for most PRVs awarded and sold.

Analysis of voucher transactions shows that while individual transaction values have varied, PRVs have maintained substantial market value over time. Even more than a decade after its introduction, the RPD PRV market remains active, highlighting continued demand for accelerated regulatory review and the program’s role in supporting rare pediatric disease innovation.

Sources:

U.S. Food and Drug Administration. (2026, April 28). Rare pediatric disease designation and priority review voucher programs.
https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/rare-pediatric-disease-designation-and-priority-review-voucher-programs

U.S. Food and Drug Administration. (2024, June 12). Tropical disease priority review voucher program. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/tropical-disease-priority-review-voucher-program

U.S. Food and Drug Administration. (2025, April 27). 21st Century Cures Act: MCM-related Cures provisions. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/21st-century-cures-act-mcm-related-cures-provisions

U.S. Government Accountability Office. (2020). Drug development: FDA’s priority review voucher programs (GAO-20-251). https://collections.nlm.nih.gov/master/borndig/9918265998906676/9918265998906676.pdf

Last updated July 8, 2026