In 2007, the FDA created the Priority Review Voucher (PRV) program to incentivize the development of drugs for rare pediatric and tropical diseases. These PRVs act as a way to skip to the front of the FDA’s line to have a future drug reviewed, which offers potential for larger capital gains. These future drugs can be for any disease or ailment and do not need to be for rare diseases. PRVs can also be sold to other companies.
Below you can find CheckRare’s chart tracking every PRV that has been issued along with the current status.
| Date of PRV Issuance | Product | Disease | Approval Date | PRV Recipient | Status of PRV | Purchase Price | PRV Buyer | Transaction Date of PRV |
|---|---|---|---|---|---|---|---|---|
| 4.9.2009 | Artemether/Lumefantrine | Malaria | 4.7.2009 | Novartis | Used | |||
| 12.28.2012 | Bedaquiline | Tuberculosis | 12.28.2012 | Janssen (JNJ) | Used | |||
| 3.12.2014 | Elosulfase alfa | Morquio A | 2.14.2014 | BioMarin Pharmaceutical, Inc | Sold | $67,500,000 | Regeneron Ireland | 7.29.2014 |
| 3.19.2014 | Miltefosine | Leishmaniasis | 3.19.2014 | Paladin/Knight | Sold | $125,000,000 | Gilead | 11.19.2014 |
| 4.7.2015 | Dinutuximab | Neuroblastoma | 3.10.2015 | United Therapeutics Corporation | Sold | $350,000,000 | AbbVie | 8.19.2015 |
| 4.7.2015 | Cholic acid | Bile acid synthesis disorders and peroxisomal disorders | 3.17.2015 | Asklepion/Retrophin | Sold | $245,000,000 | Sanofi | 5.22.2015 |
| 9.29.2015 | Uridine triacetate | Hereditary orotic aciduria | 9.4.2015 | Wellstat Therapeutics Corp | ||||
| 11.17.2015 | Asfotase alfa | Hypophosphatasia | 10.23.2015 | Alexion Pharmaceuticals | Used | |||
| 6.10.2016 | Vaxchora | Cholera | 6.10.2016 | PaxVax | Sold | $200,000,000 | Gilead | |
| 10.17.2016 | Eteplirsen | Duchenne muscular dystrophy | 9.19.2016 | Sarepta Therapeutics | Sold | $125,000,000 | Gilead | 2.20.2017 |
| 3.6.2017 | Nusinersen | Spinal muscular atrophy | 12.23.2016 | Biogen | ||||
| 4.25.2017 | Deflazacort | Duchenne muscular dystrophy | 2.9.2017 | Marathon Pharmaceuticals, LLC | ||||
| 6.26.2017 | Cerliponase alfa | Batten disease | 4.27.2017 | Biomarin Pharmaceuticals Inc | Sold | $125,000,000 | Novartis | 11.21.2017 |
| 8.29.2017 | Benznidazole | Chagas disease | 8.29.2017 | Chemo Research | ||||
| 9.11.2017 | Tisagenlecleucel | B-cell precursor acute lymphoblastic leukemia | 5.1.2018 | Novartis | ||||
| 12.15.2017 | Vestronidase alfa-vjbk | Mucopolysaccharidosis type VII | 11.15.2017 | Ultragenyx Pharmaceutical | Sold | $130,000,000 | Novartis | 12.18.2017 |
| 1.2.2018 | Voretigene neparvovec | Biallelic RPE65 mutation-associated retinal dystrophy | 12.19.2017 | Spark Therapeutics | Sold | $110,000,000 | Jazz Pharmaceuticals | 4.30.2018 |
| 6.13.2018 | Moxidectin | Onchocerciasis | 6.13.2018 | Medicines Development | Novo Nordisk | |||
| 7.19.2018 | Cannabidiol | Seizures associated with Lennox Gastaut-Syndrome and Dravet syndrome | 6.25.2018 | GW Research Ltd | Sold | $105,000,000 | Biohaven Pharmaceutical | 3.15.2019 |
| 7.20.2018 | Krintafel | Malaria | 7.20.2018 | GSK | Sold | ViiV Healthcare | ||
| 8.15.2018 | Burosamab-twza | X-linked hypophosphatemia | 4.17.2018 | Ultragenyx Pharmaceutical, Inc | Sold | $80,600,000 | Gilead | 6.1.2018 |
| 10.25.2018 | Elapegademase-lvlr | Adenosine deaminase-severe combined immunodeficiency | 10.5.2018 | Leadiant Bioscience Inc | Sold | |||
| 12.13.2018 | Emapalumab-lzsg | Hemophagocytic lymphohistiocytosis | 11.20.2018 | Novimmune/Sobi | $95,000,000 | AstraZeneca | 8.22.2019 | |
| 2.13.2019 | Egaten | Fascioliasis | 2.13.2019 | Novartis | ||||
| 3.29.2019 | Tezacaftor/ivacaftor | Biallelic RPE65 mutation-associated retinal dystrophy | 2.12.2018 | Vertex Pharmaceutical | ||||
| 4.1.2019 | Ttecovirimat | Smallpox | 7.13.2018 | SIGA Technologies | Sold | $80,000,000 | Eli Lilly | 11.1.2018 |
| 5.1.2019 | Dengvaxia | Dengue disease | 5.1.2019 | Sanofi | ||||
| 6.24.2019 | Onasemnogene abeparvovec-xioi | Spinal muscular atrophy | 5.24.2019 | AveXis | ||||
| 7.1.2019 | Sebelipase alfa | Lysosomal acid lipase deficiency | 12.8.2015 | Alexion Pharmaceuticals | ||||
| 8.14.2019 | Pretomanid | Treatment-resistant tuberculosis | 8.14.2019 | TB Alliance | ||||
| 10.9.2019 | Smallpox/Monkeypox Vaccine | Smallpox/Monkey pox | 9.24.2019 | Bavarian Nordic A/S | Sold | $95,000,000 | Unknown | 12.17.2019 |
| 12.19.2019 | Ervebo | Zaire Ebola virus disease | 12.19.2019 | Merck | ||||
| 1.23.2020 | Golodirsen | Duchenne muscular dystrophy | 12.12.2019 | Sarepta Therapeutics | Sold | $108,100,000 | Vifor Pharma | 2.17.2020 |
| 8.25.2020 | Evrysdi | Spinal muscular atrophy | 8.7.2020 | Genentech | ||||
| 9.4.2020 | Viltepso | Duchenne muscular dystrophy | 8.12.2020 | Nippon Shinyaku | ||||
| 9.15.2020 | Trikafta | Cystic fibrosis | 10.21.2019 | Vertex | ||||
| 9.16.2020 | Koselugo | Neurofibromatosis type 1 | 4.10.2020 | AstraZeneca Pharmaceuticals | ||||
| 12.7.2020 | Danyelza | Neuroblastoma | 11.25.2020 | Y-mAbs Therapeutics | ||||
| 12.17.2020 | Zokinvy | Progeria | 11.20.2020 | Eiger BioPharmaceuticals | ||||
| 12.17.2020 | Imcivree | Genetic obesity | 11.25.2020 | Rhythm Pharmaceuticals | ||||
| 2.16.2021 | Oxlumo | Primary hyperoxaluria type 1 | 11.23.2020 | Alnylam Pharmaceuticals | ||||
| 3.12.2021 | Amondys 45 | Duchenne muscular dystrophy | 2.25.2021 | Sarepta Therapeutics | Sold | $102,000,000 | Unknown | 4.1.2021 |
| 3.12.2021 | Nulibry | Molybdenum cofactor deficiency | 2.26.2021 | Origin Biosciences | ||||
| 7.2.2021 | Ryplazim | Plasminogen deficiency type 1 | 6.4.2021 | Prometic Bioproduction | Sold | $105,000,000 | Unknown | 8.9.2021 |
| 7.12.2021 | Stratagraft | Burns | 6.15.2021 | Mallinckrodt | Sold | $100,000,000 | Norvartis | 7.1.2022 |
| 7.16.2021 | fexinidazole | Sleeping sicknes | 7.16.2021 | Sanofi | ||||
| 10.27.2021 | Rethymic | Pediatric Congenital Athymia | 10.8.2021 | Enzyvant Therapeutics | ||||
| 2.17.2022 | Comirnaty | COVID vaccine | 8.16.2021 | BioNTech | ||||
| 2.17.2022 | Spikevax | COVID vaccine | 8.16.2021 | Moderna | Used | |||
| 4.29.2022 | Veklury | COVID antiviral | 8.22.2020 | Gilead Sciences | ||||
| 5.2.2022 | Inmazeb | Ebola virus | 10.14.2020 | Regeneron | ||||
| 8.29.2022 | Zynteglo | Beta-thalassemia | 8.17.2022 | Bluebird Bio | Sold | $102,000,000 | Argenx | 11.30.2022 |
| 9.6.2022 | Voxzogo | Achondroplasia | 11.9.2021 | BioMarin | Sold | $110,000,000 | Eli Lilly | 2.9.2022 |
| 9.7.2022 | Ztalmy | CDKL5 deficiency disorder | 3.18.2022 | Marinus Pharma | Sold | $110,000,000 | Novo Nordisk | 7.14.2022 |
| 10.7.2022 | Bylvay | Progressive familial intrahepatic cholestasis | 7.20.2021 | Albireo | Sold | $105,000,000 | Ares Trading | 9.7.2021 |
| 10.7.2022 | Skysona | Cerebral adrenoleukodystrophy | 9.16.2022 | Bluebird Bio | Sold | $95,000,000 | Bristol Myers Squib | 1.6.2023 |
| 3.16.2023 | Lamzede | Alpha-mannosidosis | 2.16.2023 | Chiesi Farmaceutici | ||||
| 3.16.2023 | Skyclarys | Friedreich's ataxia | 2.28.2023 | Reata Pharma | ||||
| 3.30.2023 | Daybue | Rett Syndrome | 3.10.2023 | Acadia Pharma | Sold | $150,000,000 | Unknown | 11.5.2024 |
| 4.24.2023 | Joenja | Activated PI3Kδ syndrome | 3.24.2023 | Pharming Technologies | Sold | $21,200,000 | Novartis | 6.1.2023 |
| 6.6.2023 | Vyjuvek | Dystrophic epidermolysis bullosa | 3.19.2023 | Krystal Biotech | Sold | $100,000,000 | Unknown | 8.1.2023 |
| 7.17.2023 | Elevidys | Duchenne muscular dystrophy | 6.22.2023 | Sarepta Therapeutics | Sold | $102,000,000 | Unknown | 7.5.2023 |
| 9.7.2023 | Sohonos | Fibrodysplasia ossificans progressiva | 8.16.2023 | Ipsen Biopharmaceuticals | Sold | $158,000,000 | Unknown | 8.27.2024 |
| 9.7.2023 | Veopoz | CHAPLE disease | 8.18.2023 | Regeneron | ||||
| 11.9.2023 | Ixchiq | Chikungunya vaccine | 11.9.2023 | Valneva | Sold | $103,000,000 | Novartis | 2.5.2024 |
| 12.5.2023 | Xenpozyme | Acid sphingomyelinase deficiency | 8.31.2022 | Genzyme | ||||
| 1.9.2024 | Casgevy | Sickle cell disease | 12.8.2023 | Vertex Pharma | ||||
| 1.11.2024 | Adzynma | Congenital thrombotic thrombocytopenic purpura | 11.9.2023 | Takeda | ||||
| 1.11.2024 | Filsuvez | Epidermolysis bullosa | 12.18.2023 | Amryt Pharma | ||||
| 4.11.2024 | Duvyzat | Duchenne muscular dystrophy | 3.21.2024 | Italfarmaco | ||||
| 4.18.2024 | Lenmeldy | Metachromatic leukodystrophy | 3.18.2024 | Orchard Therapeutics | ||||
| 5.15.2024 | Ojemda | Glioma | 4.23.2024 | Day One Biopharma | Sold | $108,000,000 | Unknown | 5.30.2024 |
| 5.16.2024 | Xolremdi | WHIM | 4.26.2024 | X4 Pharma | Sold | $105,000,000 | Unknown | 5.9.2024 |
| 5.28.2024 | Paxlovid | COVID-19 | 5.25.2023 | Pfizer | ||||
| 8.28.2024 | Livmarli | Cholestatic pruritus | 9.29.2021 | Mirum Pharma | Sold | $110,000,000 | Johnson and Johnson | |
| 10.15.2024 | Miplyffa | Niemann-Pick disease type C | 9.20.2024 | Zevra Therapeutics | Sold | $150,000,000 | Unknown | 2.27.2025 |
| 10.15.2024 | Aqneursa | Niemann-Pick disease type C | 9.24.2024 | IntraBio | ||||
| 12.2.2024 | Kebilidi | Aromatic L-amino acid decarboxylase deficiency | 11.13.2024 | PTC Therapeutics | Sold | $150,000,000 | Unknown | 11.27.2024 |
| 1.15.2025 | Alhemo | Hemophilia A | 12.20.2024 | Novo Nordisk | ||||
| 3.13.2025 | Gomekli | Neurofibromatosis type 1 | 2.11.2025 | SpringWorks Therapeutics | ||||
| 4.23.2025 | Ebanga | Ebola virus | 12.21.2020 | Ridgeback Biotherapeutics |