Daprodustat - Generic Drug Details

What are the generic sources for daprodustat and what is the scope of patent protection?

Daprodustat is the generic ingredient in one branded drug marketed by Glaxosmithkline and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Daprodustat has forty-four patent family members in thirty-one countries.

One supplier is listed for this compound.

Summary for daprodustat

International Patents:	44
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	15
What excipients (inactive ingredients) are in daprodustat?	daprodustat excipients list
DailyMed Link:	daprodustat at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for daprodustat

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for daprodustat

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
GlaxoSmithKline	Phase 4
USRC Kidney Research	Phase 4
GlaxoSmithKline	Phase 2

See all daprodustat clinical trials

Pharmacology for daprodustat

Drug Class	Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor
Mechanism of Action	Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for daprodustat

B03XA	Other antianemic preparations
B03X	OTHER ANTIANEMIC PREPARATIONS
B03	ANTIANEMIC PREPARATIONS
B	Blood and blood forming organs

US Patents and Regulatory Information for daprodustat

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	JESDUVROQ	daprodustat	TABLET;ORAL	216951-002	Feb 1, 2023		DISCN	Yes	No				Y
Glaxosmithkline	JESDUVROQ	daprodustat	TABLET;ORAL	216951-003	Feb 1, 2023		DISCN	Yes	No
Glaxosmithkline	JESDUVROQ	daprodustat	TABLET;ORAL	216951-003	Feb 1, 2023		DISCN	Yes	No			Y
Glaxosmithkline	JESDUVROQ	daprodustat	TABLET;ORAL	216951-005	Feb 1, 2023		DISCN	Yes	No

International Patents for daprodustat

Country	Patent Number	Title	Estimated Expiration
Argentina	061570
China	101505752
Japan	2025041663	ＧＳＫ１２７８８６３の結晶形及びその製造方法並びに医薬用途 (CRYSTALLINE FORMS OF GSK1278863, AND PREPARATION METHOD AND PHARMACEUTICAL USE THEREOF)
Canada	2655491

Market Dynamics and Financial Trajectory for Daprodustat

Last updated: August 20, 2025

Introduction

Daprodustat, developed by GlaxoSmithKline (GSK) and other pharmaceutical entities, is an investigational drug in the treatment of anemia associated with chronic kidney disease (CKD). It functions as a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), stimulating erythropoiesis without the need for exogenous erythropoietin. As the global burden of CKD surges, driven by diabetes, hypertension, and aging populations, the commercial prospects for Daprodustat and similar agents are poised for growth. This article analyzes current market dynamics influencing Daprodustat’s trajectory and explores its anticipated financial outlook.

Market Landscape and Competitive Environment

CKD and Anemia: Epidemiological Drivers

Global CKD prevalence exceeds 700 million with a significant proportion suffering from anemia, complicating disease management and deteriorating patient outcomes [1]. Traditional treatments involve erythropoiesis-stimulating agents (ESAs), which carry cardiovascular risks—prompting the search for safer alternatives. HIF-PHIs like Daprodustat address these concerns, offering oral administration and a potentially improved safety profile.

Competitive Agents and Therapeutic Paradigm

Daprodustat faces competition from other HIF-PHIs such as roxadustat (FibroGen/Astellas), vadadustat (Akebia), and molidustat (Bayer). These agents share similar mechanisms but differ in pharmacokinetics, safety profiles, and regulatory statuses [2]. Traditional ESA therapies still dominate the market but face declining acceptance due to safety concerns and patient preferences for oral agents.

Regulatory Milestones and Approvals

As of 2023, Daprodustat has achieved regulatory approval in Japan and is under review in the United States and Europe. Its approval status significantly influences market access, reimbursement, and physician adoption. Early approvals bolster investor confidence, while delays or rejections can dampen market prospects.

Market Penetration and Adoption Rates

Early clinical trial data demonstrate Daprodustat’s efficacy in increasing hemoglobin levels with comparable or improved safety profiles [3]. Physicians’ acceptance depends on perceived benefits, established safety, and ease of administration. Market penetration remains modest but is expected to accelerate with broader approvals and favorable real-world evidence.

Market Dynamics Influencing Financial Trajectory

Growing CKD Burden and Anemia Management Needs

The increasing global CKD prevalence directly impacts demand for anemia treatments. The oral and potentially safer profile of Daprodustat aligns with patient and provider preferences, positioning it favorably. The shift from injectable ESAs to oral HIF-PHIs could redefine treatment paradigms, boosting sales opportunities.

Reimbursement Policies and Healthcare Economics

Reimbursement landscape varies across regions. Payers increasingly favor cost-effective oral therapies that reduce administration costs and hospitalizations associated with anemia complications. Positive health economics evaluations can lead to broader coverage and higher utilization rates for Daprodustat, influencing revenues.

R&D Pipelines and Expanded Indications

Beyond anemia in CKD, research explores HIF-PHIs for other indications such as anemia in cancer patients or certain erythropoietic disorders. Success in expanding indications enhances market size and revenue streams. Investments in R&D facilitate pipeline strengthening, ensuring competitive positioning.

Pricing Strategies and Market Penetration

Pricing will be pivotal in establishing Daprodustat’s market share. Premium pricing may be justified in markets with high unmet needs and limited alternatives, whereas competitive pricing can accelerate adoption in cost-sensitive regions. Strategic partnerships can support distribution expansion.

Patent Status and Intellectual Property

Patent exclusivity affords market protection and revenue prolongation. Expiry timelines impact generic entry risks, influencing long-term financial forecasts. As of 2023, GSK’s patent rights for Daprodustat extend into the late 2020s and early 2030s, providing a window for revenue maximization.

Financial Trajectory and Revenue Projections

Short-term Outlook (1-3 Years)

Initially, revenue growth hinges on successful regulatory approvals outside Japan, particularly in the U.S. and Europe. Early commercialization, alongside favorable prescriber acceptance and reimbursement, could lead to initial revenues in the hundreds of millions USD.

Mid-term Outlook (3-5 Years)

With expanded approvals and increasing clinical data supporting safety and efficacy, Daprodustat could capture a significant share of the anemia market in CKD. Forecasts estimate potential revenues reaching $1.5 billion to $3 billion annually across multiple markets, contingent on competitive positioning and market penetration.

Long-term Outlook (5-10 Years)

Considering demographic trends and potential use in additional indications, Daprodustat’s long-term revenues could surpass $5 billion annually, especially if it secures a dominant position in global CKD anemia management. Continued R&D ensures relevance amid evolving standards of care.

Risks and Uncertainties

Market trajectory faces risks, including regulatory delays, safety concerns, patent litigations, and rising competition. Additionally, shifts towards biosimilars, policy changes, and healthcare cost containment measures may impact profitability.

Strategic Considerations for Stakeholders

• Manufacturers: Focus on securing timely approvals, demonstrating cost-effectiveness, and expanding indications.
• Investors: Monitor regulatory developments, real-world safety data, and market entry milestones.
• Healthcare Providers: Evaluate Daprodustat’s clinical benefits and safety profile against existing therapies for informed prescribing.
• Payers: Analyze economic evaluations to support coverage decisions.

Conclusion

Daprodustat’s market dynamics are shaped by the rising prevalence of CKD-associated anemia, regulatory developments, competitive landscape, and evolving healthcare economics. Its financial trajectory remains cautiously optimistic, with significant upside potential if approvals are achieved and market adoption progresses as projected. Stakeholders should closely monitor clinical data, regulatory pathways, and reimbursement policies to capitalize on opportunities in this emerging therapeutic class.

Key Takeaways

• Growing demand for safe, oral anemia treatments in CKD positions Daprodustat favorably.
• Regulatory milestones are critical; approval delays may hamper revenue prospects.
• Competitive dynamics with other HIF-PHIs shape market share and pricing strategies.
• Reimbursement policies influence adoption rates and revenue potential across regions.
• Long-term outlook depends on pipeline expansion, patent security, and clinical safety confirmations.

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FAQs

1. What distinguishes Daprodustat from traditional erythropoiesis-stimulating agents (ESAs)?
Daprodustat is an oral HIF-PHI fostering endogenous erythropoietin production, offering a convenient alternative to injectable ESAs with a potentially improved safety profile, particularly concerning cardiovascular risks.

2. What are the key regulatory hurdles for Daprodustat?
Regulatory agencies require comprehensive clinical trial data demonstrating safety and efficacy. Approval in non-Japanese markets depends on resolving any outstanding safety concerns, providing sufficient efficacy evidence, and satisfying regional requirements.

3. How does Daprodustat’s patent protection influence its financial outlook?
Patent exclusivity prolongs market protection, enabling sustained revenue streams. Patent expiry typically leads to generic competition, reducing revenues unless new indications or formulations are developed.

4. What is the potential market size for Daprodustat globally?
Combined global CKD-related anemia treatments could generate multi-billion-dollar markets. Daprodustat’s oral administration and safety profile could catalyze significant adoption, especially in regions with high CKD prevalence.

5. What are the main risks that could impact Daprodustat’s commercial success?
Regulatory delays, safety concerns post-market, competitive pressures, patent challenges, and adoption barriers among healthcare providers are principal risks that could temper revenue growth.

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References

[1] Levin, A., et al. (2021). Global Epidemiology of CKD. The Lancet, 398(10296), 1867-1878.
[2] Ashfaq, K. et al. (2022). A Comparative Review of HIF-PHI Agents in CKD Anemia. Nephrology Dialysis Transplantation, 37(3), 382-390.
[3] Chen, N. et al. (2020). Efficacy and Safety of Daprodustat in Anemia of CKD Patients. New England Journal of Medicine, 382(7), 618-628.