Details for New Drug Application (NDA): 217581
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NDA 217581 describes XALKORI, which is a drug marketed by Pf Prism Cv and is included in two NDAs. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the XALKORI profile page.
The generic ingredient in XALKORI is crizotinib. One supplier is listed for this compound. Additional details are available on the crizotinib profile page.
The generic ingredient in XALKORI is crizotinib. One supplier is listed for this compound. Additional details are available on the crizotinib profile page.
Summary for 217581
| Tradename: | XALKORI |
| Applicant: | Pf Prism Cv |
| Ingredient: | crizotinib |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217581
Generic Entry Date for 217581*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE, PELLETS;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: 217581
Suppliers and Packaging for NDA: 217581
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XALKORI | crizotinib | CAPSULE, PELLETS;ORAL | 217581 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0251 | 0069-0251-60 | 60 CAPSULE, COATED PELLETS in 1 BOTTLE (0069-0251-60) |
| XALKORI | crizotinib | CAPSULE, PELLETS;ORAL | 217581 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0507 | 0069-0507-60 | 60 CAPSULE, COATED PELLETS in 1 BOTTLE (0069-0507-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, PELLETS;ORAL | Strength | 20MG | ||||
| Approval Date: | Sep 7, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 14, 2025 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT AND PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH UNRESECTABLE, RECURRENT OR REFRACTORY INFLAMMATORY MYOFIBROBLASTIC TUMOR (IMT) THAT IS ANAPLASTIC LYMPHOMA KINASE (ALK) POSITIVE | ||||||||
| Regulatory Exclusivity Expiration: | Jan 14, 2024 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER AND YOUNG ADULTS WITH RELAPSED OR REFRACTORY, SYSTEMIC ANAPLASTIC LARGE CELL LYMPHOMA (ALCL) THAT IS ALK-POSITIVE | ||||||||
| Patent: | 7,230,098 | Patent Expiration: | Aug 26, 2025 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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