Details for New Drug Application (NDA): 202570
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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 202570
Tradename: | XALKORI |
Applicant: | Pf Prism Cv |
Ingredient: | crizotinib |
Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 202570
Generic Entry Date for 202570*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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: 202570
Suppliers and Packaging for NDA: 202570
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
XALKORI | crizotinib | CAPSULE;ORAL | 202570 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-8140 | 0069-8140-20 | 60 CAPSULE in 1 BOTTLE (0069-8140-20) |
XALKORI | crizotinib | CAPSULE;ORAL | 202570 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-8141 | 0069-8141-20 | 60 CAPSULE in 1 BOTTLE (0069-8141-20) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 200MG | ||||
Approval Date: | Aug 26, 2011 | 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: | Jul 14, 2029 | ||||||||
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 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 |
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