DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 202570
» See Plans and Pricing
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 |
Generic Entry Opportunity 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: | Mar 11, 2023 | ||||||||
Regulatory Exclusivity Use: | |||||||||
Patent: | Start Trial | Patent Expiration: | Aug 26, 2025 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
Patent: | Start Trial | Patent Expiration: | May 12, 2027 | Product Flag? | Substance Flag? | Delist Request? |
Complete Access Available with Subscription