Details for New Drug Application (NDA): 202570
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NDA 202570 describes XALKORI, which is a drug marketed by Pf Prism Cv and is included in one NDA. 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 202570
| Tradename: | XALKORI |
| Applicant: | Pf Prism Cv |
| Ingredient: | crizotinib |
| Patents: | 5 |
| Formulation / Manufacturing: | see details |
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: | Mar 11, 2023 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER WHOSE TUMORS ARE ROS-1 POSITIVE. | ||||||||
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