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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for REZUROCK
*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 |
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 | ||||
| >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
Estimated Expiration: ⤷ Sign Up
Patent: 51343
Estimated Expiration: ⤷ Sign Up
China
Patent: 5120869
Estimated Expiration: ⤷ Sign Up
Patent: 3620933
Estimated Expiration: ⤷ Sign Up
Patent: 3637007
Estimated Expiration: ⤷ Sign Up
Patent: 3637008
Estimated Expiration: ⤷ Sign Up
Patent: 3773308
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 |
|---|---|---|---|
| Japan | 6419076 | ⤷ Sign Up | |
| Spain | 2549397 | ⤷ Sign Up | |
| Singapore | 155163 | PHARMACOKINETICALLY IMPROVED COMPOUNDS | ⤷ 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 |
Make Better Decisions: Try a trial or see plans & pricing
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.
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