BELUMOSUDIL MESYLATE - Generic Drug Details
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What are the generic drug sources for belumosudil mesylate and what is the scope of freedom to operate?
Belumosudil mesylate
is the generic ingredient in one branded drug marketed by Kadmon Pharms Llc and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Belumosudil mesylate has forty-seven patent family members in twenty-seven countries.
One supplier is listed for this compound.
Summary for BELUMOSUDIL MESYLATE
| International Patents: | 47 |
| US Patents: | 5 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 1 |
| DailyMed Link: | BELUMOSUDIL MESYLATE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BELUMOSUDIL MESYLATE
*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 BELUMOSUDIL MESYLATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| M.D. Anderson Cancer Center | Phase 1/Phase 2 |
| Sanofi US Services, Inc | Phase 1/Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for BELUMOSUDIL MESYLATE
US Patents and Regulatory Information for BELUMOSUDIL MESYLATE
| 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 | Y | Y | ⤷ 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 BELUMOSUDIL MESYLATE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2008534518 | ⤷ Sign Up | |
| Australia | 2006230159 | Pharmacokinetically improved compounds | ⤷ Sign Up |
| European Patent Office | 1865958 | COMPOSES PHARMACOCINETIQUEMENT AMELIORES (PHARMACOKINETICALLY IMPROVED COMPOUNDS) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BELUMOSUDIL MESYLATE
| 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 |
