Prescription medicine
Momelotinib Brand names: Ojjaara
Momelotinib (Ojjaara) is a prescription medicine with an FDA approval on record since 2023. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the momelotinib FDA label on DailyMed (effective July 20, 2026, GlaxoSmithKline LLC); the NDA 216873 record on Drugs@FDA; every momelotinib label on DailyMed.
Highlights of the record
FDA label of July 20, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageOJJAARA is indicated for the treatment of intermediate or high‑risk myelofibrosis (MF), including primary MF or secondary MF [post‑polycythemia vera (PV) and post‑essential thrombocythemia (ET)], in adults with anemia.
Forms and strengths
- 100 mg
- 150 mg
- 200 mg
Tablet.
On the market
- Earliest approval on file
- September 15, 2023 Ojjaara, Glaxosmithkline; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- December 2, 2040 Ojjaara 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
- 1,339 through July 30, 2026
What is momelotinib used for?
From the label: indications and usageOJJAARA is indicated for the treatment of intermediate or high‑risk myelofibrosis (MF), including primary MF or secondary MF [post‑polycythemia vera (PV) and post‑essential thrombocythemia (ET)], in adults with anemia. OJJAARA is a kinase inhibitor indicated for the treatment of intermediate or high‑risk myelofibrosis (MF), including primary MF or secondary MF [post‑polycythemia vera (PV) and post‑essential thrombocythemia (ET)], in adults with anemia.
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (Ojjaara), GlaxoSmithKline LLC, effective July 20, 2026 (SPL set 4a672fd1-eb7b-4aa9-9b23-845e4b5dc400), via openFDA; the full label on DailyMed
Is there a generic for momelotinib (Ojjaara)?
No generic momelotinib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 5 patents for Ojjaara tablets: the compound patent runs to June 11, 2035, and the last listed entry to December 2, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2023 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 momelotinib label say about other medicines?
The momelotinib label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 1 other medicine name momelotinib. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Rosuvastatin | drug interactions | Breast Cancer Resistance Protein (BCRP) substrates: Reduce rosuvastatin (BCRP substrate) dosage. |
Source: FDA drug label (Ojjaara), GlaxoSmithKline LLC, effective July 20, 2026 (SPL set 4a672fd1-eb7b-4aa9-9b23-845e4b5dc400), via openFDA; the full label on DailyMed
What do FAERS reports show for momelotinib?
The FDA Adverse Event Reporting System holds 1,339 reports that list momelotinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 208 are coded as a death and 303 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
- Momelotinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other