Details for New Drug Application (NDA): 219839
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NDA 219839 describes ZEGFROVY, which is a drug marketed by Dizal Jiangsu and is included in one NDA. There are three patents protecting this drug. Additional details are available on the ZEGFROVY profile page.
The generic ingredient in ZEGFROVY is sunvozertinib. Additional details are available on the sunvozertinib profile page.
The generic ingredient in ZEGFROVY is sunvozertinib. Additional details are available on the sunvozertinib profile page.
Summary for 219839
| Tradename: | ZEGFROVY |
| Applicant: | Dizal Jiangsu |
| Ingredient: | sunvozertinib |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219839
Generic Entry Date for 219839*:
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.
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
| Approval Date: | Jul 2, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 2, 2030 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 11,007,198 | Patent Expiration: | Jan 28, 2039 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | 11,504,375 | Patent Expiration: | Jan 28, 2039 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF PATIENTS WITH NON-SMALL CELL LUNG CANCER (NSCLC) WITH EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 20 EXON INSERTION MUTATIONS WHOSE DISEASE HAS PROGRESSED ON OR AFTER PLATINUM-BASED CHEMOTHERAPY | ||||||||
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