Details for New Drug Application (NDA): 214783
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NDA 214783 describes REZUROCK, which is a drug marketed by Kadmon Pharms Llc and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the REZUROCK profile page.
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.
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.
Summary for 214783
| Tradename: | REZUROCK |
| Applicant: | Kadmon Pharms Llc |
| Ingredient: | belumosudil mesylate |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214783
Generic Entry Date for 214783*:
Constraining patent/regulatory exclusivity:
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.
Suppliers and Packaging for NDA: 214783
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| REZUROCK | belumosudil mesylate | TABLET;ORAL | 214783 | NDA | Kadmon Pharmaceuticals, LLC | 79802-200 | 79802-200-30 | 1 BOTTLE in 1 CARTON (79802-200-30) / 30 TABLET in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 200MG BASE | ||||
| Approval Date: | Jul 16, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 16, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Jul 16, 2028 | ||||||||
| Regulatory Exclusivity Use: | 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 | ||||||||
| Patent: | 10,183,931 | Patent Expiration: | Oct 7, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | FOR THE TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE | ||||||||
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