Details for New Drug Application (NDA): 211288
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NDA 211288 describes VIZIMPRO, which is a drug marketed by Pfizer and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug. Additional details are available on the VIZIMPRO profile page.
The generic ingredient in VIZIMPRO is dacomitinib. Two suppliers are listed for this compound. Additional details are available on the dacomitinib profile page.
The generic ingredient in VIZIMPRO is dacomitinib. Two suppliers are listed for this compound. Additional details are available on the dacomitinib profile page.
Summary for 211288
| Tradename: | VIZIMPRO |
| Applicant: | Pfizer |
| Ingredient: | dacomitinib |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211288
Generic Entry Date for 211288*:
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: 211288
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VIZIMPRO | dacomitinib | TABLET;ORAL | 211288 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0197 | 0069-0197-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0069-0197-30) |
| VIZIMPRO | dacomitinib | TABLET;ORAL | 211288 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-1198 | 0069-1198-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0069-1198-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 15MG | ||||
| Approval Date: | Sep 27, 2018 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 27, 2025 | ||||||||
| Regulatory Exclusivity Use: | FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETION OR EXON 21 L858R SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST | ||||||||
| Regulatory Exclusivity Expiration: | Sep 27, 2025 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH EPIDERMAL GROWTH FACTOR (EGFR) EXON 19 DELETION OR EXON 21 L858R SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST | ||||||||
| Patent: | 10,596,162 | Patent Expiration: | Feb 2, 2026 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | ADMINISTERING DAILY A UNIT DOSAGE OF AN IRREVERSIBLE EGFR INHIBITOR COVALENTLY BINDING AS CLAIMED FOR 1ST LINE TREATMENT OF GEFITINIB OR ERLOTINIB RESISTANT METASTATIC NSCLC WITH EGFR EXON 19 DELETION OR EXON 21 L858R SUBSTITUTION WITH T790M MUTATION | ||||||||
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