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WELIREG Drug Patent Profile

Which patents cover Welireg, and what generic alternatives are available?

Welireg is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are two patents protecting this drug.

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

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

DrugPatentWatch^® Generic Entry Outlook for Welireg

Welireg will be eligible for patent challenges on August 13, 2025. 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 September 5, 2034. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for WELIREG

International Patents:	53
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	29
Clinical Trials:	3
Patent Applications:	35
Drug Prices:	Drug price information for WELIREG
What excipients (inactive ingredients) are in WELIREG?	WELIREG excipients list
DailyMed Link:	WELIREG at DailyMed

See drug prices for WELIREG

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

Constraining patent/regulatory exclusivity:

9,908,845

NDA:

215383

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 WELIREG

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

Sponsor	Phase
Merck Sharp & Dohme Corp.	Phase 1
Peloton Therapeutics, Inc.	Phase 2

See all WELIREG clinical trials

Pharmacology for WELIREG

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

US Patents and Regulatory Information for WELIREG

WELIREG is protected by four US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 9,908,845.

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
Merck Sharp Dohme	WELIREG	belzutifan	TABLET;ORAL	215383-001	Aug 13, 2021		RX	Yes	Yes	9,908,845		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	RE49948		Y	Y

International Patents for WELIREG

When does loss-of-exclusivity occur for WELIREG?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Canada

China

Croatia

Cuba

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Mexico

New Zealand

Peru

Poland

Portugal

Serbia

Singapore

Slovenia

South Korea

Spain

Taiwan

Uruguay

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

See the table below for additional patents covering WELIREG around the world.

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)

WELIREG Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for WELIREG

Introduction to WELIREG

WELIREG, also known as belzutifan, is a groundbreaking cancer drug developed by Merck & Co. following its acquisition of Peloton Therapeutics in 2019 for $1.1 billion. This drug is the first hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor approved in the U.S. for the treatment of certain cancers.

Initial Approval and Early Market Performance

Initially approved in 2021, WELIREG was cleared for the treatment of adult patients with von Hippel-Lindau (VHL) disease, a rare genetic disorder associated with renal cell carcinoma (RCC), central nervous system hemangioblastomas, and pancreatic neuroendocrine tumors not requiring immediate surgery[3][4].

In its first year of approval, WELIREG generated $40 million in sales, a modest start but one that indicated potential for growth. By the first half of 2023, sales had significantly increased to $92 million, reflecting growing adoption and recognition within the medical community[1].

Expansion into Advanced Renal Cell Carcinoma (RCC)

A pivotal milestone for WELIREG came with its approval for the treatment of advanced RCC in patients who have progressed following treatment with a PD-1 or PD-L1 inhibitor and a vascular endothelial growth factor-tyrosine kinase inhibitor (VEGF-TKI). This expansion was based on the LITESPARK-005 trial, which demonstrated statistically significant improvements in progression-free survival (PFS) and objective response rate (ORR) compared to everolimus[3][4].

Clinical Efficacy and Market Impact

The LITESPARK-005 trial showed that WELIREG reduced the risk of disease progression or death by 25% compared to everolimus, with a median PFS of 5.6 months. The ORR for WELIREG was 22%, significantly higher than the 4% ORR for everolimus. While WELIREG has not yet proven to provide a survival benefit, its impact on cancer progression and tumor response rates is substantial[3][4].

Market Opportunity and Growth Potential

The approval for advanced RCC opens up a larger market opportunity for WELIREG compared to its initial indication for VHL disease. This expansion positions WELIREG as a potential blockbuster drug, with sales expected to rise substantially. As of the first nine months of 2023, WELIREG had generated about $146 million in sales, a figure that is anticipated to grow with its new indication[4].

Financial Performance and Projections

Merck's financial reports reflect the growing importance of WELIREG. In the first half of 2023, WELIREG's sales more than doubled from the previous year, indicating strong market acceptance. While the drug's overall contribution to Merck's revenue is still modest compared to other flagship products like Keytruda, its growth trajectory is promising.

For the full year 2023, Merck's overall sales were $60.1 billion, with a slight increase from the previous year. The company's focus on expanding the indications for drugs like WELIREG is part of its strategy to diversify its revenue streams and mitigate the impact of patent cliffs, such as the looming 2028 patent expiration for Keytruda[5].

Challenges and Future Directions

Despite the positive clinical data and market expansion, there are questions about the long-term benefits of WELIREG, particularly regarding its impact on overall survival. Some oncologists have expressed skepticism about its value, which could influence prescribing habits and patient outcomes. Merck is likely to continue studying WELIREG in various settings to address these concerns and further establish its efficacy[4].

Competitive Landscape

In the competitive landscape of cancer treatments, WELIREG stands out as a novel HIF-2α inhibitor. Its unique mechanism of action differentiates it from other therapies, such as checkpoint inhibitors and VEGF-TKIs. As the market for RCC treatments continues to evolve, WELIREG's position as a third-line treatment option post-immunotherapy and VEGF-TKI therapy could solidify its market share[3][4].

Regulatory and Clinical Trials

The rapid approval of WELIREG for advanced RCC, just months after Merck reported positive interim results, highlights the regulatory body's recognition of its clinical significance. Ongoing and future trials will be crucial in further establishing WELIREG's efficacy and addressing any lingering questions about its benefits[3][4].

Patient and Physician Adoption

The adoption of WELIREG by both patients and physicians will be influenced by its clinical performance, side effect profile, and the overall treatment experience. Positive word-of-mouth and clinical outcomes will be key drivers in increasing its market penetration.

Global Market Potential

While the current approvals and sales data are primarily from the U.S. market, WELIREG's potential extends globally. As regulatory approvals are sought and obtained in other regions, the drug's global market potential is expected to expand significantly.

Key Takeaways

• Approval and Indications: WELIREG is approved for VHL disease and advanced RCC post-PD-1/PD-L1 and VEGF-TKI therapy.
• Clinical Efficacy: Demonstrated significant improvements in PFS and ORR in advanced RCC.
• Market Performance: Sales have increased substantially since its initial approval.
• Growth Potential: Positioned as a potential blockbuster with significant market opportunity.
• Challenges: Questions about overall survival benefits and ongoing clinical trials to address these concerns.
• Competitive Landscape: Unique mechanism of action as a HIF-2α inhibitor.

FAQs

Q: What is WELIREG and how does it work? A: WELIREG (belzutifan) is a HIF-2α inhibitor that blocks the production of a protein implicated in cancer growth, particularly in renal cell carcinoma and VHL disease.

Q: What are the approved indications for WELIREG? A: WELIREG is approved for the treatment of adult patients with VHL disease and for advanced RCC in patients who have progressed following treatment with a PD-1 or PD-L1 inhibitor and a VEGF-TKI.

Q: What were the key findings of the LITESPARK-005 trial? A: The trial showed that WELIREG reduced the risk of disease progression or death by 25% and improved the ORR to 22% compared to everolimus in advanced RCC patients.

Q: How has WELIREG performed financially since its approval? A: WELIREG generated $40 million in its first year and $92 million in the first half of 2023, indicating strong growth and market acceptance.

Q: What are the future directions and challenges for WELIREG? A: Merck is studying WELIREG in various settings to address questions about its long-term benefits, particularly regarding overall survival, and to further establish its efficacy.

Cited Sources

1. FiercePharma: Merck looks to broaden Welireg's kidney cancer reach, mission to hit blockbuster status.
2. Exelixis: Exelixis Announces Third Quarter 2024 Financial Results and.
3. Merck: 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.
4. BioPharma Dive: FDA widens use of cancer drug Merck acquired for $1B.
5. Merck: Merck Announces Fourth-Quarter and Full-Year 2023 Financial Results.