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REZUROCK Drug Patent Profile

When do Rezurock patents expire, and what generic alternatives are available?

Rezurock is a drug marketed by Kadmon Pharms Llc and is included in one NDA. There are five patents protecting this drug.

This drug has forty-nine patent family members in twenty-seven countries.

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

DrugPatentWatch^® Generic Entry Outlook for Rezurock

Rezurock will be eligible for patent challenges on July 16, 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 October 30, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for REZUROCK

International Patents:	49
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	7
Drug Prices:	Drug price information for REZUROCK
What excipients (inactive ingredients) are in REZUROCK?	REZUROCK excipients list
DailyMed Link:	REZUROCK at DailyMed

See drug prices for REZUROCK

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

Constraining patent/regulatory exclusivity:

8,357,693

NDA:

214783

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 REZUROCK

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

Sponsor	Phase
Sanofi	Phase 3
Kadmon, a Sanofi Company	Phase 2
Kadmon Corporation, LLC	Phase 1

See all REZUROCK clinical trials

US Patents and Regulatory Information for REZUROCK

REZUROCK is protected by five US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 8,357,693.

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
Kadmon Pharms Llc	REZUROCK	belumosudil mesylate	TABLET;ORAL	214783-001	Jul 16, 2021		RX	Yes	Yes	12,097,202
Kadmon Pharms Llc	REZUROCK	belumosudil mesylate	TABLET;ORAL	214783-001	Jul 16, 2021		RX	Yes	Yes
Kadmon Pharms Llc	REZUROCK	belumosudil mesylate	TABLET;ORAL	214783-001	Jul 16, 2021		RX	Yes	Yes	10,183,931
Kadmon Pharms Llc	REZUROCK	belumosudil mesylate	TABLET;ORAL	214783-001	Jul 16, 2021		RX	Yes	Yes	11,311,541
Kadmon Pharms Llc	REZUROCK	belumosudil mesylate	TABLET;ORAL	214783-001	Jul 16, 2021		RX	Yes	Yes	10,696,660
Kadmon Pharms Llc	REZUROCK	belumosudil mesylate	TABLET;ORAL	214783-001	Jul 16, 2021		RX	Yes	Yes

International Patents for REZUROCK

When does loss-of-exclusivity occur for REZUROCK?

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

Australia

Brazil

Canada

China

Costa Rica

Ecuador

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Japan

Mexico

New Zealand

Norway

Singapore

South Africa

South Korea

Spain

Ukraine

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 REZUROCK around the world.

Country	Patent Number	Title	Estimated Expiration
Ecuador	SP077836	COMPUESTOS MEJORADOS FARMACOCINÉTICAMENTE
Eurasian Patent Organization	022875	ПРОИЗВОДНЫЕ 4-(ИНДАЗОЛ-5-ИЛ-АМИНО)-2-ФЕНИЛХИНАЗОЛИНА (4-(INDAZOLE-5-YLAMINO)-2-PHENYLQUINAZOLIN DERIVATIVES)
European Patent Office	4116293	INHIBITEURS DE RHO KINASE (RHO KINASE INHIBITORS)
China	105120869	Rho kinase inhibitors
Japan	6419076
Serbia	63503	INHIBITORI RHO KINAZE (RHO KINASE INHIBITORS)

Supplementary Protection Certificates for REZUROCK

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2903618	SPC/GB22/068	United Kingdom		PRODUCT NAME: BELUMOSUDIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK PLGB 53904/0001-0001 20220707

REZUROCK Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for REZUROCK

Introduction

REZUROCK, also known as belumosudil, is a significant player in the treatment of chronic graft-versus-host disease (cGvHD), a complication that can occur after a stem cell or bone marrow transplant. Here, we will delve into the market dynamics and financial trajectory of REZUROCK, highlighting its current position, sales performance, and future projections.

Approval and Market Entry

REZUROCK was approved by the FDA in July 2021 for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (cGvHD) after failure of at least two prior lines of systemic therapy. This approval marked a crucial milestone in the treatment landscape for cGvHD, offering a new therapeutic option for patients who had limited alternatives[1].

Current Market Position

Since its approval, REZUROCK has quickly established itself as a leading treatment for cGvHD. As of the latest reports, REZUROCK has treated approximately 30% of the current potential patient pool worldwide. This rapid adoption is reflected in its strong sales figures, with revenues of approximately USD 220 million in just the first year after approval[1].

Sales Performance

The sales performance of REZUROCK has been impressive. In the second quarter of 2024, REZUROCK sales increased by 52.7% to €114 million, and for the first half of 2024, sales rose by 46.8% to €207 million. This growth is driven by new patient adoption and improved patient adherence, particularly in the U.S.[3].

In the fourth quarter of 2023, REZUROCK sales were €86 million, up 44.4% from the previous quarter, further solidifying its position in the market[4].

Physician Preference

REZUROCK has gained significant traction among healthcare providers. A survey indicated that more than 70% of doctors showed interest in prescribing REZUROCK after the failure of ruxolitinib (JAKAFI), another commonly used treatment for cGvHD. This preference is due to REZUROCK's additional advantages over other branded drugs, despite similar costs[1].

Financial Projections

The financial trajectory for REZUROCK looks promising. It is estimated to generate peak sales of approximately USD 500 million. This projection is based on its current market performance and the growing demand for effective treatments for cGvHD[1].

Challenges and Future Outlook

Despite its strong performance, REZUROCK faces potential challenges in the future. One significant concern is the patent expiration in 2026, which could lead to a decline in sales as generic alternatives enter the market. However, until then, REZUROCK is expected to continue its dominance in the cGvHD treatment landscape[1].

Competitive Landscape

The cGvHD treatment market is competitive, with other drugs like JAKAFI and IMBRUVICA. However, REZUROCK's unique advantages and strong physician preference have allowed it to outperform these competitors. The market dynamics suggest that REZUROCK will remain a top influencer in this space for the foreseeable future[1].

Impact on Patient Care

REZUROCK's success is not just financial; it also represents a significant improvement in patient care. By offering an effective treatment option for cGvHD, REZUROCK has improved the quality of life for many patients. This impact is reflected in the increased patient adherence and new patient adoption rates[4].

Conclusion

REZUROCK has established itself as a leader in the treatment of chronic graft-versus-host disease, with strong sales figures and a favorable physician preference. While it faces future challenges, particularly with its patent expiration, its current financial trajectory and market position indicate continued dominance in the cGvHD treatment landscape.

Key Takeaways

• Strong Market Position: REZUROCK has treated approximately 30% of the current potential patient pool worldwide.
• Impressive Sales: Sales of approximately USD 220 million in the first year after approval, with continued growth in subsequent quarters.
• Physician Preference: Over 70% of doctors prefer REZUROCK after the failure of ruxolitinib (JAKAFI).
• Financial Projections: Estimated peak sales of approximately USD 500 million.
• Future Challenges: Patent expiration in 2026 could impact sales.

FAQs

Q1: What is REZUROCK used for? REZUROCK (belumosudil) is used for the treatment of chronic graft-versus-host disease (cGvHD) in adult and pediatric patients 12 years and older who have failed at least two prior lines of systemic therapy.

Q2: How has REZUROCK performed in the market since its approval? Since its approval, REZUROCK has shown strong sales performance, treating approximately 30% of the current potential patient pool worldwide and generating revenues of approximately USD 220 million in the first year.

Q3: Why do doctors prefer REZUROCK over other treatments? Doctors prefer REZUROCK due to its additional advantages over other branded drugs like JAKAFI, despite similar costs. Over 70% of doctors have shown interest in prescribing REZUROCK after the failure of ruxolitinib (JAKAFI).

Q4: What are the financial projections for REZUROCK? REZUROCK is estimated to generate peak sales of approximately USD 500 million, based on its current market performance and growing demand.

Q5: What challenges might REZUROCK face in the future? One significant challenge for REZUROCK is the patent expiration in 2026, which could lead to a decline in sales as generic alternatives enter the market.

Sources

1. DelveInsight: Graft-Versus-Host Disease (GvHD) Treatment Market.
2. Meiji: Consolidated Financial Results for the Fiscal Year Ended March 31, 2024.
3. Sanofi: Q2 2024 Financial Results.
4. Sanofi: Q4 2023 Financial Results.