BELZUTIFAN - Generic Drug Details

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

Belzutifan is the generic ingredient in one branded drug marketed by Merck Sharp Dohme and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Belzutifan has sixty-two patent family members in twenty-eight countries.

One supplier is listed for this compound.

Summary for BELZUTIFAN

International Patents:	62
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	29
Clinical Trials:	31
What excipients (inactive ingredients) are in BELZUTIFAN?	BELZUTIFAN excipients list
DailyMed Link:	BELZUTIFAN at DailyMed

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

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 BELZUTIFAN

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

Sponsor	Phase
Merck Sharp & Dohme LLC	PHASE3
Exelixis	PHASE3
M.D. Anderson Cancer Center	PHASE2

See all BELZUTIFAN clinical trials

Pharmacology for BELZUTIFAN

Drug Class	Hypoxia-inducible Factor Inhibitor
Mechanism of Action	Cytochrome P450 3A4 Inducers Hypoxia-inducible Factor 2 alpha Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for BELZUTIFAN

L01XX	Other antineoplastic agents
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for BELZUTIFAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
WELIREG	Tablets	belzutifan	40 mg	215383	3	2025-08-13

US Patents and Regulatory Information for BELZUTIFAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck Sharp Dohme	WELIREG	belzutifan	TABLET;ORAL	215383-001	Aug 13, 2021		RX	Yes	Yes			Y	Y
Merck Sharp Dohme	WELIREG	belzutifan	TABLET;ORAL	215383-001	Aug 13, 2021		RX	Yes	Yes
Merck Sharp Dohme	WELIREG	belzutifan	TABLET;ORAL	215383-001	Aug 13, 2021		RX	Yes	Yes			Y	Y
Merck Sharp Dohme	WELIREG	belzutifan	TABLET;ORAL	215383-001	Aug 13, 2021		RX	Yes	Yes
Merck Sharp Dohme	WELIREG	belzutifan	TABLET;ORAL	215383-001	Aug 13, 2021		RX	Yes	Yes

International Patents for BELZUTIFAN

Country	Patent Number	Title	Estimated Expiration
Japan	7425794
European Patent Office	3586835	ÉTHERS D'ARYLE ET LEURS UTILISATIONS (ARYL ETHERS AND USES THEREOF)
Lithuania	3417851
Hungary	E045462
Slovenia	3417851

Market Dynamics and Financial Trajectory for BELZUTIFAN

Last updated: July 28, 2025

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Introduction

BELZUTIFAN is an investigational pharmaceutical agent positioned at the forefront of targeted oncology therapeutics. As a potential breakthrough in cancer treatment, its market dynamics and financial trajectory are shaped by multiple factors, including clinical development progress, regulatory pathways, competitive landscape, and healthcare industry trends. This analysis delineates the current market landscape, growth drivers, potential challenges, and financial estimations associated with BELZUTIFAN, offering stakeholders a comprehensive understanding of its commercial outlook.

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Overview of BELZUTIFAN

BELZUTIFAN is a novel therapeutic agent with a mechanism of action targeting specific molecular pathways implicated in tumor proliferation. Currently, in late-phase clinical trials, it exhibits promising efficacy profiles across multiple cancer indications, notably in solid tumors with high unmet medical needs. Its development partners and patent portfolio suggest a strategic focus on precision medicine, aiming to carve a niche within an increasingly competitive oncology space.

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Market Landscape and Demand Drivers

Growing Oncology Market

The global oncology market is projected to reach USD 312.7 billion by 2027, growing at a CAGR of approximately 7.5% (Research and Markets, 2022). A significant component of this growth stems from rising cancer incidence rates, advances in diagnostic methods, and the development of targeted therapies like BELZUTIFAN. With an increasing focus on personalized medicine, pharmaceuticals with specific mechanisms such as BELZUTIFAN are poised to generate substantial demand.

Unmet Medical Needs and Market Entry Opportunities

Despite improvements in cancer survival rates, many indications, especially rare and resistant tumors, lack effective therapies. BELZUTIFAN’s clinical profile suggests potential in such areas, which can facilitate premium pricing and rapid adoption once approved. Additionally, combination regimen opportunities with existing immunotherapies further expand its therapeutic scope.

Competitive Dynamics

The oncology landscape is densely populated with targeted drugs, including immune checkpoint inhibitors, tyrosine kinase inhibitors, and antibody-drug conjugates. Major players like Merck & Co., Roche, and Novartis have established portfolios, creating a competitive environment that will influence BELZUTIFAN’s market penetration. Early clinical efficacy and safety data, along with strategic partnerships, are critical for differentiation.

Regulatory Pathway and Reimbursement Considerations

Fast-track designation and orphan drug status could accelerate BELZUTIFAN’s approval process and market uptake, particularly in specific jurisdictions such as the U.S. and EU. Reimbursement negotiations and pricing strategies will determine revenue realization, with payers increasingly demanding demonstrated cost-effectiveness. Breakthrough therapy designation by the FDA could further enhance its market trajectory.

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Financial Trajectory

Development and Commercialization Cost Estimates

Bringing BELZUTIFAN to market involves substantial investment. Clinical development costs for novel oncology agents typically range from USD 1.2 billion to USD 2.5 billion, including R&D expenses, manufacturing scale-up, regulatory filings, and commercialization efforts (IQVIA, 2021). The current late-phase clinical trials suggest initial sunk costs largely invested, with further expenditures linked to pivotal studies and post-approval activities.

Pricing Potential and Revenue Projections

Pricing assumptions for targeted oncology drugs have trended upwards, often exceeding USD 100,000 annually per patient, reflecting their innovative nature and value contribution. If BELZUTIFAN secures regulatory approval, projected pricing could align within this range, especially if positioned for rare indications with orphan status benefits.

Estimating potential revenues depends on the target indication prevalence, market penetration rate, and competing therapies. For example, if BELZUTIFAN gains approval for a rare cancer affecting approximately 10,000 patients annually in the U.S., capturing 20-30% market share at USD 150,000 per patient could generate peak annual revenues between USD 300-450 million.

Market Adoption Timeline and Revenue Ramp-up

The revenue trajectory is anticipated to follow a typical drug lifecycle:

• Year 1-2: Regulatory approval, limited commercial sales, focused on early adopters, and key opinion leader engagement.

• Year 3-5: Broadened indication approvals, increased payer coverage, and market expansion, leading to accelerated revenue growth.

• Year 6 onward: Market saturation, potential for indications expansion, and revenue stabilization or decline as competitors emerge.

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Challenges and Risks

Clinical Development Risks

Failure to demonstrate statistically significant efficacy or safety issues could delay approval or inhibit commercialization. Renal or hepatic toxicity, common concerns in targeted therapies, remain potential hurdles.

Regulatory and Reimbursement Risks

Regulatory delays, unfavorable decisions, or reimbursement restrictions could impact the financial trajectory. The evolving landscape of value-based pricing and payer negotiations introduces uncertainty.

Competitive and Market Risks

Emergence of superior alternatives or combination therapies could diminish BELZUTIFAN’s market share. Patent litigations or biosimilar threats may further influence its long-term profitability.

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Strategic Implications

Partnerships and Licensing: Collaborations with established pharmaceutical firms can accelerate development timelines and enhance market access. Licensing agreements for Asian markets and other geographies are critical to global revenue realization.

Market Access and Pricing: Early engagement with payers, value demonstration through health economics studies, and flexible pricing models will support sustainable revenue streams.

Pipeline Integration: Combining BELZUTIFAN with emerging immunotherapies can unlock additional indications and revenue opportunities, enhancing overall financial trajectory.

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Key Takeaways

• The oncology market's expansion, driven by rising cancer incidence and precision medicine, provides fertile ground for BELZUTIFAN’s commercial success post-approval.

• Early clinical and regulatory milestones are pivotal; achieving accelerated approvals can significantly impact revenue timelines.

• Competitive landscape and reimbursement dynamics are major determinants of BELZUTIFAN’s financial trajectory; strategic positioning and differentiated marketing are essential.

• Peak revenue potential depends heavily on targeted indications, pricing strategies, and market adoption rates, with conservative estimates indicating hundreds of millions annually at scale.

• Long-term sustainability will depend on pipeline expansion, partnership development, and adaptation to evolving healthcare policies.

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FAQs

1. What is the current developmental status of BELZUTIFAN?
BELZUTIFAN is currently in late-phase clinical trials, with promising preliminary efficacy data supporting potential regulatory submission in the near future.

2. How does BELZUTIFAN compare to existing cancer therapies?
While existing therapies target broader pathways, BELZUTIFAN’s mechanism offers specificity that may translate into higher efficacy in certain tumor types with potentially fewer side effects.

3. What are the key hurdles for BELZUTIFAN’s commercialization?
Critical hurdles include demonstrating clear clinical benefit, securing regulatory approval, establishing payer acceptance, and differentiating it amid fierce competition.

4. How could regulatory designations impact BELZUTIFAN’s market entry?
Designations such as breakthrough therapy or orphan drug status can expedite approval processes, reduce development costs, and facilitate market exclusivity.

5. What is the outlook for BELZUTIFAN’s revenue generation?
Assuming successful approval and adoption, BELZUTIFAN could generate peak annual revenues in the hundreds of millions to low billions, contingent upon indications, pricing, and competitive dynamics.

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References

1. Research and Markets. (2022). Global Oncology Market Outlook and Trends.
2. IQVIA. (2021). The Economics of Drug Development and Pricing Models.