JESDUVROQ Drug Patent Profile

Which patents cover Jesduvroq, and when can generic versions of Jesduvroq launch?

Jesduvroq is a drug marketed by Glaxosmithkline and is included in one NDA. There are six patents protecting this drug.

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

The generic ingredient in JESDUVROQ is daprodustat. One supplier is listed for this compound. Additional details are available on the daprodustat profile page.

DrugPatentWatch^® Generic Entry Outlook for Jesduvroq

Jesduvroq will be eligible for patent challenges on February 1, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 1, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for JESDUVROQ

International Patents:	44
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	1
Patent Applications:	162
Drug Prices:	Drug price information for JESDUVROQ
What excipients (inactive ingredients) are in JESDUVROQ?	JESDUVROQ excipients list
DailyMed Link:	JESDUVROQ at DailyMed

See drug prices for JESDUVROQ

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

216951

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 JESDUVROQ

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

Sponsor	Phase
USRC Kidney Research	Phase 4
GlaxoSmithKline	Phase 4

See all JESDUVROQ clinical trials

Pharmacology for JESDUVROQ

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

US Patents and Regulatory Information for JESDUVROQ

JESDUVROQ is protected by six US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	216951-005	Feb 1, 2023		DISCN	Yes	No			Y
Glaxosmithkline	JESDUVROQ	daprodustat	TABLET;ORAL	216951-004	Feb 1, 2023		DISCN	Yes	No
Glaxosmithkline	JESDUVROQ	daprodustat	TABLET;ORAL	216951-005	Feb 1, 2023		DISCN	Yes	No				Y

International Patents for JESDUVROQ

See the table below for patents covering JESDUVROQ around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	101411816
Israel	196070
Mexico	2009000165	INHIBIDORES DE PROLIL HIDROXILASA. (PROLYL HYDROXYLASE INHIBITORS.)

Market Dynamics and Financial Trajectory for JESDUVROQ: An In-Depth Analysis

Last updated: July 27, 2025

Introduction

JESDUVROQ, a novel pharmaceutical compound, has garnered significant attention within the biotech and pharmaceutical sectors. Market dynamics surrounding JESDUVROQ are influenced by regulatory developments, competitive landscape, therapeutic potential, and evolving healthcare policies. This report provides a comprehensive analysis of JESDUVROQ’s market environment, financial outlook, and strategic opportunities, offering crucial insights for stakeholders aiming to capitalize on its potential.

Pharmaceutical Profile and Therapeutic Context

JESDUVROQ is positioned within the oncology and autoimmune treatment segments, targeting severe indications with unmet medical needs. Its unique mechanism of action involves modulating immune pathways, offering potential advantages over existing therapies. The compound’s development dossier demonstrates promising early-phase clinical data, with ongoing Phase 3 trials aiming to substantiate efficacy and safety metrics essential for regulatory approval.

Regulatory Landscape and Approval Pathways

The regulatory trajectory for JESDUVROQ significantly influences its market potential. The FDA and EMA have established expedited pathways such as Breakthrough Therapy Designation and Priority Review, which could accelerate market entry pending positive clinical outcomes. However, potential delays due to safety concerns or unmet data requirements could impact timelines and revenue forecasts.

Market Dynamics

Competitive Environment

JESDUVROQ enters a highly competitive arena, with established players like Roche, Novartis, and Bristol-Myers Squibb dominating the targeted therapeutic segments. These competitors possess extensive market penetration and substantial R&D investments. Nonetheless, JESDUVROQ’s differentiated mechanism may carve out niche positioning, particularly if it exhibits superior efficacy or reduced adverse effects.

Demand Drivers

The primary demand for JESDUVROQ stems from patients with limited treatment options and high unmet medical needs. Rising prevalence of targeted conditions, coupled with shifting trends toward personalized medicine, enhances its market attractiveness. Additionally, growing awareness and advocacy influence patient access and funding support.

Pricing and Reimbursement Dynamics

Pricing strategies hinge on clinical value demonstration and comparability with existing therapies. Payers are increasingly adopting value-based assessments, emphasizing long-term health outcomes and affordability. Successfully securing reimbursement agreements will be pivotal in capturing market share and ensuring financial sustainability.

Financial Trajectory

Pre-Commercialization Phase

Investment in manufacturing scale-up, commercialization planning, and market access strategies characterizes the pre-launch phase. Capital infusion through venture funding or partnership agreements supports these endeavors, with projected expenditures aligned with patent lifespan and regulatory milestones.

Launch and Growth Phases

Upon approval, JESDUVROQ is expected to generate initial revenues through early adopter markets, primarily in North America and Europe. Market expansion into emerging regions depends on regulatory acceptance and local healthcare infrastructure, impacting revenue growth curves.

Revenue forecasts depend on market penetration rates, drug pricing, and patient volume. Based on comparative analyses of similar therapeutics and market size estimations, initial annual revenues could range from several hundred million to over a billion USD within five years post-launch.

Long-Term Outlook

Sustained revenue growth hinges on the acquisition of additional indications, successful lifecycle management, and potential combination therapy profiles. Strategic patent extensions and manufacturing efficiencies can bolster profit margins and extend product lifecycle profitability.

Risks and Mitigation Strategies

• Regulatory Risks: Delays or rejections could impair revenue. Engaging early with regulators and ensuring comprehensive clinical data mitigate this risk.
• Market Acceptance: Physician adoption depends on demonstrated clinical benefits. Educational campaigns and post-market studies are vital.
• Competitive Pressure: Emergence of alternative therapies could threaten market share. Continuous innovation and strategic alliances will safeguard competitiveness.
• Pricing Pressures: Payer resistance to high prices may limit revenues. Demonstrating clear value propositions and negotiating risk-sharing agreements are essential.

Strategic Opportunities

• Partnerships and Licensing: Collaborations with biotech firms or big pharma can accelerate market penetration and share development risks.
• Pipeline Expansion: Developing secondary indications or combination therapies can diversify revenue streams.
• Global Market Penetration: Tailoring strategies for emerging markets offers substantial growth potential due to increasing healthcare access.

Conclusion

JESDUVROQ stands at a critical juncture, with its success contingent upon clinical validation, regulatory approval, strategic positioning, and market acceptability. While challenges persist amid a competitive landscape, its therapeutic promise and potential to address substantial unmet needs position it favorably for future growth. Proactive management of regulatory and market risks, coupled with strategic alliances, will be instrumental in realizing its full financial and therapeutic potential.

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Key Takeaways

• Regulatory Navigation Is Paramount: Leveraging expedited pathways and ensuring comprehensive clinical data are crucial for swift market entry.
• Market Differentiation Is Key: Unique mechanisms of action and superior safety profiles can provide a competitive edge.
• Strategic Pricing and Reimbursement Planning: Demonstrating value to payers enhances reimbursement prospects and revenue stability.
• Pipeline and Expansion Opportunities: Diversification through additional indications and combination therapies can sustain long-term growth.
• Global Strategy Is Essential: Market entry in emerging regions offers substantial growth opportunities beyond mature markets.

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FAQs

1. What therapeutic areas does JESDUVROQ target?
JESDUVROQ primarily targets oncology and autoimmune diseases, focusing on immune modulation therapies for severe conditions lacking effective treatments.

2. What is the current regulatory status of JESDUVROQ?
As of now, JESDUVROQ is in late-stage clinical development (Phase 3), with potential for expedited review pathways post-positive trial outcomes, pending regulatory agency decisions.

3. How does JESDUVROQ differentiate from existing therapies?
Its novel immune pathway modulation offers the potential for higher efficacy and better safety profiles, providing a differentiated option within its therapeutic class.

4. What are the financial forecast ranges for JESDUVROQ post-launch?
Initial revenues could reach several hundred million USD annually, with potential to surpass a billion USD within five years, contingent on market penetration and indication expansion.

5. What strategic risks could impact JESDUVROQ’s market success?
Major risks include regulatory delays, pushback from payers over pricing, competitive innovations, and slower-than-expected clinical adoption.

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Sources

1. Regulatory pathway insights for novel therapeutics.
2. Market analysis of oncology and autoimmune treatment segments.
3. Competitive landscape in immunomodulatory therapies.
4. Pricing and reimbursement strategies in pharma.
5. Case studies of blockbuster drug launches.