Prescription medicine
Ruxolitinib Brand names: Jakafi, Opzelura
Ruxolitinib (Opzelura) is a prescription medicine with an FDA approval on record since 2011. No generic is listed; pharmacies paid $34.01 per gram (Opzelura 1.5% cream) in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the ruxolitinib FDA label on DailyMed (effective July 20, 2026, Incyte Corporation); the NDA 202192 record on Drugs@FDA; every ruxolitinib label on DailyMed.
Highlights of the record
FDA label of July 20, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageJAKAFI/JAKAFI XR is a kinase inhibitor indicated for treatment of: intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis in adults.
Forms and strengths
- 5 mg
- 10 mg
- 11 mg
- 15 mg
- 20 mg
- 22 mg
- 25 mg
- 33 mg
- 44 mg
- 55 mg
- 15 mg/g
Tablet; extended-release tablet; cream.
On the market
- Earliest approval on file
- November 16, 2011 Jakafi, Incyte Corp; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- May 5, 2041 Opzelura cream; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $34.01 per gram Opzelura 1.5% cream
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 71,241 through July 30, 2026
What is ruxolitinib used for?
From the label: indications and usageJAKAFI/JAKAFI XR is a kinase inhibitor indicated for treatment of: intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis in adults. ( 1.1 ) polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea. ( 1.2 ) steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older. ( 1.3 ) chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. […]
Conditions named in the indications of ruxolitinib's FDA labels, with every medicine labeled for each:
From other ruxolitinib labelsEczema (atopic dermatitis): Atopic Dermatitis OPZELURA is indicated for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 2 years of age and older whose disease is …
FDA pharmacologic class: Janus Kinase Inhibitor and Kinase Inhibitor.
Source: FDA drug label (JAKAFI), Incyte Corporation, effective July 20, 2026 (SPL set f1c82580-87ae-11e0-bc84-0002a5d5c51b), via openFDA; the full label on DailyMed
Is there a generic for ruxolitinib (Opzelura)?
No generic ruxolitinib is approved (Drugs@FDA, October 8, 2026). Drugs@FDA also holds 3 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 22 patents for Opzelura cream: the compound patent runs to June 12, 2028 (pediatric exclusivity to December 12, 2028), and the last listed entry to May 5, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2011 earliest approval on file
- 2041 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ruxolitinib (Opzelura)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $34.01 per gram (Opzelura 1.5% cream), up 2% from $33.48 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Opzelura 1.5% cream (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Opzelura 1.5% cream | Brand | $34.01 per gram | n/a | +2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the ruxolitinib label say about other medicines?
The ruxolitinib label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 1 other medicine name ruxolitinib. 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 |
|---|---|---|
| Fluconazole | drug interactions | DRUG INTERACTIONS Fluconazole: Avoid concomitant use with fluconazole doses greater than 200 mg. |
Other labels that name ruxolitinib
Source: FDA drug label (JAKAFI), Incyte Corporation, effective July 20, 2026 (SPL set f1c82580-87ae-11e0-bc84-0002a5d5c51b), via openFDA; the full label on DailyMed
What do FAERS reports show for ruxolitinib?
The FDA Adverse Event Reporting System holds 71,241 reports that list ruxolitinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 9,813 are coded as a death and 13,602 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
How does ruxolitinib compare with medicines for the same use?
1 side-by-side page set ruxolitinib beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Other janus kinase inhibitors
- the pharmacologic class, with prices and generics
- Ruxolitinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other