Prescription medicine
Pemigatinib Brand names: Pemazyre
Pemigatinib (Pemazyre) is a prescription medicine with an FDA approval on record since 2020. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the pemigatinib FDA label on DailyMed (effective June 9, 2026, Incyte Corporation); the NDA 213736 record on Drugs@FDA; every pemigatinib label on DailyMed.
Highlights of the record
FDA label of June 9, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usagePEMAZYRE is a kinase inhibitor indicated: for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.
Forms and strengths
- 4.5 mg
- 9 mg
- 13.5 mg
Tablet.
On the market
- Earliest approval on file
- April 17, 2020 Pemazyre, Incyte Corp; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- October 3, 2040 Pemazyre tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 821 through July 30, 2026
What is pemigatinib used for?
From the label: indications and usagePEMAZYRE is a kinase inhibitor indicated: for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. ( 1 , 2.1 ) This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 , 2.1 ) For the treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement. […]
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (PEMAZYRE), Incyte Corporation, effective June 9, 2026 (SPL set 9e1f2222-1d89-4e63-989c-ccebe2ab1eb4), via openFDA; the full label on DailyMed
Is there a generic for pemigatinib (Pemazyre)?
No generic pemigatinib is approved (Drugs@FDA, October 8, 2026). Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 5 patents for Pemazyre tablets: the compound patent runs to October 3, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2020 earliest approval on file
- 2040 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the pemigatinib label say about other medicines?
The pemigatinib label names no other medicine on this site. The labels of 1 other medicine name pemigatinib. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name pemigatinib
Source: FDA drug label (PEMAZYRE), Incyte Corporation, effective June 9, 2026 (SPL set 9e1f2222-1d89-4e63-989c-ccebe2ab1eb4), via openFDA; the full label on DailyMed
What do FAERS reports show for pemigatinib?
The FDA Adverse Event Reporting System holds 821 reports that list pemigatinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 144 are coded as a death and 197 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Pemigatinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other