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 four patents protecting this drug. Additional details are available on the WELIREG profile page.
The generic ingredient in WELIREG is belzutifan. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the belzutifan profile page.
The generic ingredient in WELIREG is belzutifan. There is one drug master file entry for this compound. 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: | 4 |
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: | Jun 12, 2029 | ||||||||
| Regulatory Exclusivity Use: | IN COMBINATION WITH PEMBROLIZUMAB OR PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH FOR THE ADJUVANT TREATMENT OF ADULT PATIENTS WITH RENAL CELL CARCINOMA WITH A CLEAR CELL COMPONENT (CCRCC) AT INTERMEDIATE-HIGH OR HIGH RISK OF RECURRENCE FOLLOWING NEPHRECTOMY, OR FOLLOWING NEPHRECTOMY AND RESECTION OF METASTATIC LESIONS | ||||||||
| Regulatory Exclusivity Expiration: | Aug 13, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | May 14, 2028 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 12 YEARS AND OLDER WITH LOCALLY ADVANCED, UNRESECTABLE, OR METASTATIC PHEOCHROMOCYTOMA OR PARAGANGLIOMA (PPGL) | ||||||||
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