Question 1

Is there a generic for Crizotinib?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Crizotinib. It is available as 2 brand (NDA) applications.

Question 2

What is the reference-listed drug for Crizotinib?

Accepted Answer

XALKORI (NDA 217581, PF PRISM CV) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Crizotinib?

Accepted Answer

The Orange Book lists 3 patents against Crizotinib products, with the earliest listed expiry in 2027. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Crizotinib have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 4 marketing-exclusivity periods for Crizotinib. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Crizotinib are approved?

Accepted Answer

Crizotinib is approved in the following dosage forms: capsule, capsule, pellets.

Product	Applicant	Application	TE	Approved
XALKORIRLD×3	PF PRISM CV	NDA 217581	—	Sep 07, 2023
XALKORIRLD×2	PF PRISM CV	NDA 202570	—	Aug 26, 2011

Patent	Expires	In	Type
7825137	May 12, 2027	in 11 mo	U-3057
7858643	Oct 08, 2029	in 3 yr 4 mo	SubstanceProduct
8217057	Nov 06, 2029	in 3 yr 5 mo	Substance

Crizotinib

Brand (NDA) products · capsule, capsule, pellets

Marketing exclusivity (4)

Listed patents (3)

Crizotinib — frequently asked questions

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