Rezurock is a drug owned by Kadmon Pharmaceuticals Llc. It is protected by 6 US drug patents filed from 2021 to 2024 out of which none have expired yet. Rezurock's patents will be open to challenges from 16 July, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 14, 2042. Details of Rezurock's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8357693 | Pharmacokinetically improved compounds |
Oct, 2029
(4 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US12097202 | Methods of administering Belumosudil for treatment of chronic graft versus host disease |
Jul, 2042
(17 years from now) | Active |
| US11311541 | Treatment of GVHD |
Apr, 2035
(9 years from now) | Active |
| US10696660 | Rho kinase inhibitors |
Oct, 2033
(8 years from now) | Active |
| US9815820 | Rho kinase inhibitors |
Oct, 2033
(8 years from now) | Active |
| US10183931 | Rho kinase inhibitors |
Oct, 2033
(8 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Rezurock's patents.
Latest Legal Activities on Rezurock's Patents
Given below is the list of recent legal activities going on the following patents of Rezurock.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 10 Jul, 2024 | US8357693 |
| transaction for FDA Determination of Regulatory Review Period | 18 Jan, 2024 | US8357693 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 13 Dec, 2023 | US10696660 |
| transaction for FDA Determination of Regulatory Review Period | 30 Nov, 2023 | US8357693 |
| Electronic Review Critical | 01 Jun, 2023 | US10696660 |
| Mail Certificate of Correction Memo | 31 May, 2023 | US10696660 |
| Post Issue Communication - Certificate of Correction | 30 May, 2023 | US10696660 |
| Certificate of Correction Memo | 26 May, 2023 | US10696660 |
| Electronic Review Critical | 25 May, 2023 | US10183931 |
| Electronic Review Critical | 25 May, 2023 | US9815820 |
FDA has granted several exclusivities to Rezurock. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Rezurock, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Rezurock.
Exclusivity Information
Rezurock holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Rezurock's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 16, 2026 |
| Orphan Drug Exclusivity(ODE-362) | Jul 16, 2028 |
Several oppositions have been filed on Rezurock's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Rezurock's generic, the next section provides detailed information on ongoing and past EP oppositions related to Rezurock patents.
Rezurock's Oppositions Filed in EPO
Rezurock has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 28, 2023, by Elkington And Fife Llp. This opposition was filed on patent number EP13843426A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP13843426A | Feb, 2023 | SANDOZ AG | Granted and Under Opposition |
| EP13843426A | Feb, 2023 | ELKINGTON AND FIFE LLP | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Rezurock is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Rezurock's family patents as well as insights into ongoing legal events on those patents.
Rezurock's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Rezurock's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 14, 2042 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Rezurock Generics:
There are no approved generic versions for Rezurock as of now.
About Rezurock
Rezurock is a drug owned by Kadmon Pharmaceuticals Llc. It is used for treating chronic graft-versus-host disease in adults and pediatric patients. Rezurock uses Belumosudil Mesylate as an active ingredient. Rezurock was launched by Kadmon Pharms Llc in 2021.
Approval Date:
Rezurock was approved by FDA for market use on 16 July, 2021.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Rezurock is 16 July, 2021, its NCE-1 date is estimated to be 16 July, 2025.
Active Ingredient:
Rezurock uses Belumosudil Mesylate as the active ingredient. Check out other Drugs and Companies using Belumosudil Mesylate ingredient
Treatment:
Rezurock is used for treating chronic graft-versus-host disease in adults and pediatric patients.
Dosage:
Rezurock is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 200MG BASE | TABLET | Prescription | ORAL |