Details for New Drug Application (NDA): 215383
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NDA 215383 describes WELIREG, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the WELIREG profile page.
The generic ingredient in WELIREG is belzutifan. One supplier is listed for this compound. Additional details are available on the belzutifan profile page.
The generic ingredient in WELIREG is belzutifan. One supplier is listed for this compound. Additional details are available on the belzutifan profile page.
Summary for 215383
| Tradename: | WELIREG |
| Applicant: | Merck Sharp Dohme |
| Ingredient: | belzutifan |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215383
Generic Entry Date for 215383*:
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.
Pharmacology for NDA: 215383
| Mechanism of Action | Cytochrome P450 3A4 Inducers Hypoxia-inducible Factor 2 alpha Inhibitors |
Suppliers and Packaging for NDA: 215383
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| WELIREG | belzutifan | TABLET;ORAL | 215383 | NDA | Merck Sharp & Dohme LLC | 0006-5331 | 0006-5331-01 | 90 TABLET, FILM COATED in 1 BOTTLE (0006-5331-01) |
| WELIREG | belzutifan | TABLET;ORAL | 215383 | NDA | Merck Sharp & Dohme LLC | 0006-5331 | 0006-5331-58 | 1 BOTTLE in 1 CARTON (0006-5331-58) / 90 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | Aug 13, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 13, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Dec 14, 2026 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH ADVANCED RENAL CELL CARCINOMA FOLLOWING A PROGRAMMEDDEATH RECEPTOR-1 OR PROGRAMMED DEATH-LIGAND 1 INHIBITOR AND A VASCULAR ENDOTHELIAL GROWTH FACTOR TYROSINE KINASE INHIBITOR | ||||||||
| Regulatory Exclusivity Expiration: | Aug 13, 2028 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH VON HIPPEL-LINDAU (VHL) DISEASE WHO REQUIRE THERAPY FOR ASSOCIATED RENAL CELL CARCINOMA (RCC), CENTRAL NERVOUS SYSTEM (CNS) HEMANGIOBLASTOMAS, OR PANCREATIC NEUROENDOCRINE TUMORS (PNET), NOT REQUIRING IMMEDIATE SURGERY | ||||||||
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