Details for New Drug Application (NDA): 217581
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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: | ⤷ Sign Up | Patent Expiration: | Aug 26, 2025 | Product Flag? | Substance Flag? | Y | Delist Request? |
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