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-eight patent family members in twenty-eight 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 7, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for REZUROCK

International Patents:	48
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	5
Patent Applications:	154
What excipients (inactive ingredients) are in REZUROCK?	REZUROCK excipients list
DailyMed Link:	REZUROCK at DailyMed

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for REZUROCK

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
Kadmon, a Sanofi Company	Phase 2
Quotient Sciences	Phase 1
Kadmon Corporation, LLC	Phase 1

See all REZUROCK clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for REZUROCK

L04AA	Selective immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for REZUROCK

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

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

Patents protecting REZUROCK

FDA Regulatory Exclusivity protecting REZUROCK

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
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
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

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:

Canada

China

Croatia

Denmark

Eurasian Patent Organization

European Patent Office

Finland

Japan

Lithuania

Poland

Portugal

Slovenia

Spain

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
Japan	6703075
Australia	2006230159	Pharmacokinetically improved compounds
Hungary	E059305
China	113773308	RHO激酶抑制剂 (RHO KINASE INHIBITORS)
European Patent Office	1865958	COMPOSES PHARMACOCINETIQUEMENT AMELIORES (PHARMACOKINETICALLY IMPROVED COMPOUNDS)