Last updated: February 19, 2026
Daprodustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), is developed to treat anemia related to chronic kidney disease (CKD). Several pharmaceutical companies have advanced daprodustat through development, commercialization, or partnered manufacturing.
Key Suppliers Overview
| Company |
Role |
Development Stage |
Notable Details |
| FibroGen Inc. |
Developer, Licensee |
Approved in some markets |
Invented daprodustat, holds key patents |
| AstraZeneca |
Licensee, Collaborator |
Commercial Partner |
Holds exclusive rights in certain regions |
| Jiangsu Hengrui Medicine |
Contract Manufacturer |
Early-stage |
Manufacturing agreements in China |
| WuXi AppTec |
Contract Manufacturing |
Clinical and Commercial |
Provides synthesis and formulation services |
| GILEAD Sciences |
Licensee (for some markets) |
Preclinical / Phase 3 |
Licensing partner in specific territories |
Development and Commercialization Status
FibroGen Inc.: Originator of daprodustat, holds original patents filed in multiple jurisdictions. The FDA accepted their New Drug Application (NDA) in 2021 for anemia in CKD patients on dialysis, with decision anticipated in 2023. European Medicines Agency (EMA) submission also underway.
AstraZeneca: Signed licensing agreements with FibroGen in 2019, covering development, manufacturing, and commercialization in North America, the European Union, and Japan. AstraZeneca's involvement includes substantial investments in clinical trials and regulatory filings.
Jiangsu Hengrui Medicine: Engaged as a manufacturing partner, primarily in China, where it produces daprodustat for local distribution.
WuXi AppTec: Provides contract manufacturing services, including active pharmaceutical ingredient (API) synthesis and formulation scaling.
GILEAD Sciences: Has licensing rights for daprodustat in certain markets like Latin America, progressing through late-stage clinical trials.
Manufacturing and Supply Chain
-
API Production: Wuxi AppTec and Jiangsu Hengrui are the principal API manufacturers, with capacity scaling based on demand and regional distribution needs.
-
Formulation and Fill-Finish: Contracted to multiple CMOs, including WuXi AppTec, with facilities adhering to Good Manufacturing Practices (GMP).
-
Distribution: Limited to regions where regulatory approval exists. Daprodustat is marketed in some countries, under licensing agreements.
Regulatory and Patent Landscape
- Patent filings date back to 2012, with key patents held by FibroGen expiring between 2030 and 2040, depending on jurisdiction.
- Daprodustat has received fast-track designations in some regions, expediting review processes.
- Regulatory approval processes vary; FDA approval expected in 2023, EMA review ongoing.
Strategic Considerations for Risk and Supply
- Supply Risks: Reliance on a limited number of API manufacturers introduces potential bottlenecks.
- Patent Expiry: Patent lifespan considerations impact generic competition post-2030.
- Regional Licenses: Licensing arrangements narrow the supplier base in specific markets but broaden access globally.
Key Takeaways
Daprodustat's supply chain hinges mainly on FibroGen as the inventor and patent holder, with AstraZeneca and Gilead providing significant licensing and commercialization capacity. Manufacturing is split among API producers and CMOs, primarily WuXi AppTec and Jiangsu Hengrui. Regulatory approval in key markets is pending, with commercialization opportunities expanding in the coming years.
FAQs
Q1. Who are the primary developers and licensors of daprodustat?
FibroGen developed daprodustat and holds primary patents; AstraZeneca and Gilead manage licensing in specific regions.
Q2. Which companies are manufacturing daprodustat API?
WuXi AppTec and Jiangsu Hengrui Medicine provide API synthesis and large-scale production.
Q3. When is daprodustat expected to receive regulatory approval?
The FDA is reviewing the NDA submitted by FibroGen, with decisions anticipated in 2023.
Q4. What are potential risks in daprodustat’s supply chain?
Limited API manufacturing capacity and regional licensing restrict supply; patent expirations after 2030 could lead to generic availability.
Q5. In which regions is daprodustat commercially available?
Available in some markets via licensing agreements, including select regions in Asia, North America, and Europe; regulatory status varies globally.
References
- FibroGen Inc. (2022). Daprodustat clinical trial data and regulatory filings.
- European Medicines Agency. (2022). Daprodustat marketing authorization application.
- FDA. (2022). NDA submission status for daprodustat.
- Gilead Sciences Inc. (2022). Licensing agreements for daprodustat.
- Jiangsu Hengrui Medicine Co., Ltd. (2022). API manufacturing capabilities.
