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Last Updated: July 18, 2024

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REZUROCK Drug Patent Profile


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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-seven 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 7, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for REZUROCK
International Patents:47
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
Drug patent expirations by year for REZUROCK
Drug Prices for REZUROCK

See drug prices for REZUROCK

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for REZUROCK
Generic Entry Date for REZUROCK*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
SanofiPhase 3
Kadmon, a Sanofi CompanyPhase 2
Kadmon Corporation, LLCPhase 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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of REZUROCK is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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

Rho kinase inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: FOR THE TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE

Rho kinase inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: FOR THE TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE

Treatment of GVHD
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF ADULTS AND PEDIATRIC PATIENTS 12 AND OLDER WITH SCLERODERMATOUS FORM OF CHRONIC GRAFT-VERSUS-HOST DISEASE ( CGVHD) AFTER FAILURE OF AT LEAST TWO PRIOR LINES OF SYSTEMIC THERAPY

Pharmacokinetically improved compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: FOR THE TREATMENT OF CHRONIC GRAFT VERSUS HOLD DISEASE

Rho kinase inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: FOR THE TREATMENT OF CHRONIC GRAFT VERSUS HOLD DISEASE

FDA Regulatory Exclusivity protecting REZUROCK

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CHRONIC GVHD) AFTER FAILURE OF AT LEAST TWO PRIOR LINES OF SYSTEMIC THERAPY
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Kadmon Pharms Llc REZUROCK belumosudil mesylate TABLET;ORAL 214783-001 Jul 16, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Kadmon Pharms Llc REZUROCK belumosudil mesylate TABLET;ORAL 214783-001 Jul 16, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Kadmon Pharms Llc REZUROCK belumosudil mesylate TABLET;ORAL 214783-001 Jul 16, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

Patent: 26478
Patent: INHIBITEURS DE RHO KINASE (RHO KINASE INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Patent: 51343
Patent: INHIBITEURS DE RHO KINASE (RHO KINASE INHIBITORS)
Estimated Expiration: ⤷  Sign Up

China

Patent: 5120869
Patent: Rho kinase inhibitors
Estimated Expiration: ⤷  Sign Up

Patent: 3620933
Patent: RHO激酶抑制剂 (RHO KINASE INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Patent: 3637007
Patent: RHO激酶抑制剂 (RHO KINASE INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Patent: 3637008
Patent: RHO激酶抑制剂 (RHO KINASE INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Patent: 3773308
Patent: RHO激酶抑制剂 (RHO KINASE INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0220913
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 03618
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 1500362
Patent: ИНГИБИТОРЫ RHO-КИНАЗЫ
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 03618
Patent: INHIBITEURS DE RHO KINASE (RHO KINASE INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Patent: 16293
Patent: INHIBITEURS DE RHO KINASE (RHO KINASE INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 59305
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 19076
Estimated Expiration: ⤷  Sign Up

Patent: 03075
Estimated Expiration: ⤷  Sign Up

Patent: 15533125
Patent: RHOキナーゼ阻害剤
Estimated Expiration: ⤷  Sign Up

Patent: 19034949
Patent: RHOキナーゼ阻害剤 (RHO KINASE INHIBITOR)
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 03618
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 03618
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 03618
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 503
Patent: INHIBITORI RHO KINAZE (RHO KINASE INHIBITORS)
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 03618
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 24915
Estimated Expiration: ⤷  Sign Up

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
China 101208094 Pharmacokinetically improved compounds ⤷  Sign Up
South Korea 20080081122 PHARMACOKINETICALLY IMPROVED COMPOUNDS ⤷  Sign Up
Croatia P20220913 ⤷  Sign Up
Japan 2019034949 RHOキナーゼ阻害剤 (RHO KINASE INHIBITOR) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for REZUROCK

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.