Belzutifan - Generic Drug Details

What are the generic drug sources for belzutifan and what is the scope of freedom to operate?

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

Belzutifan has fifty-three patent family members in twenty-eight countries.

One supplier is listed for this compound.

Summary for belzutifan

International Patents:	53
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	29
Clinical Trials:	20
Patent Applications:	49
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
Johns Hopkins Bloomberg School of Public Health	Phase 2
Merck Sharp & Dohme LLC	Phase 1/Phase 2
Merck Sharp & Dohme LLC	Phase 3

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

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
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
Merck Sharp Dohme	WELIREG	belzutifan	TABLET;ORAL	215383-001	Aug 13, 2021		RX	Yes	Yes			Y	Y

International Patents for belzutifan

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	201690549	АРИЛЭФИРЫ И ИХ ПРИМЕНЕНИЯ
Eurasian Patent Organization	032124	АРИЛЭФИРЫ И ИХ ПРИМЕНЕНИЯ (ARYL ETHERS AND USES THEREOF)
Canada	2919397	ARYLETHERS ET UTILISATIONS DE CEUX-CI (ARYL ETHERS AND USES THEREOF)
Denmark	3043784
Japan	6918039
Spain	2739433
Taiwan	201605775	Aryl ethers and uses thereof

Belzutifan Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Belzutifan (WELIREG)

Introduction to Belzutifan

Belzutifan, marketed as WELIREG, is a groundbreaking drug developed by Merck, approved for the treatment of various conditions, including advanced renal cell carcinoma (RCC) and tumors associated with von Hippel-Lindau (VHL) disease. This article delves into the market dynamics and financial trajectory of belzutifan, highlighting its clinical significance, market impact, and economic considerations.

Clinical Significance and Market Need

Belzutifan is a first-in-class, oral hypoxia-inducible factor (HIF)-2α inhibitor, targeting a key oncogenic driver in clear cell renal cancer. The drug has shown significant improvements in progression-free survival and overall response rates compared to everolimus in patients with advanced RCC, particularly those who have progressed after PD-1/PD-L1 and VEGFR-targeted therapies[2][4].

FDA Approval and Regulatory Landscape

The FDA approved belzutifan for the treatment of adults with VHL-associated renal cell carcinoma, central nervous system hemangioblastomas, and pancreatic neuroendocrine tumors in 2021. More recently, it was approved for the treatment of adult patients with advanced RCC who have received prior therapies, including PD-1 or PD-L1 inhibitors and VEGF TKIs[2][3].

Market Impact

The approval of belzutifan fills a critical gap in the treatment landscape for advanced RCC. Dr. Toni K. Choueiri, study chair of the LITESPARK-005 trial, emphasized that this approval introduces a meaningful new treatment option for patients whose disease progresses after standard therapies[2].

Competitive Landscape

Belzutifan's entry into the market for advanced RCC is significant, given the limited treatment options available for patients who have failed previous therapies. The drug's superior progression-free survival and overall response rates compared to everolimus position it as a potential new standard in this patient population[4].

Patient and Clinician Perspectives

Patients and clinicians have expressed strong support for belzutifan due to its ability to improve physical condition, quality of life, and offer long-term stability or reduction of disease. Patient groups have advocated for widespread access to belzutifan based on individual informed decisions between patients, their families, and treating physicians[5].

Financial Trajectory

Revenue Potential

Given its clinical efficacy and the unmet need in the advanced RCC market, belzutifan is expected to generate significant revenue. The drug's approval for multiple indications, including VHL-associated tumors and advanced RCC, expands its market reach and potential revenue streams.

Cost and Access

The ongoing need for monitoring and care associated with belzutifan could present geographic and financial barriers. However, patient groups and clinicians have emphasized the importance of access to this treatment, suggesting that the benefits outweigh the costs. Economic evaluations and reimbursement reviews are crucial in determining the drug's accessibility and affordability[5].

Economic Evaluations

The Canadian Agency for Drugs and Technologies in Health (CADTH) has conducted a comprehensive reimbursement review of belzutifan. The review highlights the need for careful economic evaluation, considering factors such as quality of life improvements, long-term disease stability, and the potential to avoid surgery. These evaluations are essential for informing healthcare policy and ensuring that patients have access to this life-changing treatment[5].

Market Dynamics

Market Growth

The market for renal cell carcinoma treatments is expected to grow, driven by increasing incidence rates and the need for effective therapies. Belzutifan's approval and positive clinical trial results position it to capture a significant share of this growing market.

Partnerships and Collaborations

Merck has been proactive in presenting data from clinical trials such as LITESPARK-005 and LITESPARK-003 at major oncology conferences, including the European Society for Medical Oncology (ESMO) Congress. These efforts help in building clinical and market momentum for belzutifan[4].

Challenges and Opportunities

Regulatory and Reimbursement Challenges

While belzutifan has received FDA approval, its adoption may be influenced by reimbursement policies and regulatory approvals in different regions. Ensuring broad access and reimbursement will be crucial for its financial success.

Combination Therapies

Belzutifan's potential in combination with other therapies, such as cabozantinib, has shown promising results in clinical trials. Exploring these combination therapies could further enhance its market position and revenue potential[4].

Key Takeaways

• Clinical Efficacy: Belzutifan has demonstrated significant improvements in progression-free survival and overall response rates in patients with advanced RCC.
• Market Need: The drug addresses a critical unmet need for patients who have progressed after standard therapies.
• Regulatory Approvals: FDA approvals for multiple indications expand its market reach.
• Financial Trajectory: Expected to generate significant revenue due to its clinical efficacy and market need.
• Access and Affordability: Economic evaluations and reimbursement reviews are crucial for ensuring patient access.

FAQs

1. What is belzutifan used for?

   • Belzutifan (WELIREG) is used for the treatment of adults with von Hippel-Lindau (VHL) disease-associated tumors and advanced renal cell carcinoma (RCC) who have received prior therapies.

2. How does belzutifan work?

   • Belzutifan is a first-in-class, oral hypoxia-inducible factor (HIF)-2α inhibitor, targeting a key oncogenic driver in clear cell renal cancer.

3. What are the clinical trial results for belzutifan?

   • Clinical trials, such as LITESPARK-005, have shown that belzutifan significantly reduces the risk of disease progression or death and improves overall response rates compared to everolimus in patients with advanced RCC[2][4].

4. Is belzutifan approved by regulatory authorities?

   • Yes, belzutifan has received FDA approval for the treatment of VHL-associated tumors and advanced RCC following prior therapies[2][3].

5. What are the potential challenges for belzutifan's market adoption?

   • Challenges include regulatory and reimbursement approvals, ensuring broad access, and managing the ongoing need for monitoring and care associated with the drug[5].

Sources

1. Merck's WELIREG® (belzutifan) Significantly Improved Progression-Free Survival and Objective Response Rates Versus Everolimus in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma (RCC) - Merck News.
2. FDA Approves Merck's WELIREG® (belzutifan) for the Treatment of Patients With Advanced Renal Cell Carcinoma (RCC) Following a PD-1 or PD-L1 Inhibitor and a VEGF TKI - Biospace.
3. Belzutifan Approved for Tumors Linked to VHL - National Cancer Institute.
4. Belzutifan New Standard in Previously Treated Renal Cell Carcinoma - ASCO Post.
5. CADTH Reimbursement Review Belzutifan (Welireg) - CADTH.