Prescription medicine
Dupilumab Brand names: Dupixent
Dupilumab (Dupixent) is a prescription medicine with an FDA approval on record since 2017. No generic is listed; pharmacies paid $1,773.74 per mL (Dupixent 200 mg/1.14 mL syring) in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the dupilumab FDA label on DailyMed (effective April 22, 2026, Sanofi-Aventis U.S. LLC); the BLA 761055 record on Drugs@FDA; every dupilumab label on DailyMed.
Highlights of the record
FDA label of April 22, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageDUPIXENT is an interleukin-4 receptor alpha antagonist indicated: Atopic Dermatitis for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
Forms and strengths
- 200 mg/1.14ml
- 300 mg/2ml
Injection (solution).
On the market
- Earliest approval on file
- March 28, 2017 Dupixent, Regeneron Pharmaceuticals; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
Supply and safety
- Pharmacy cost (NADAC)
- $1,773.74 per mL Dupixent 200 mg/1.14 mL syring
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 478,975 through July 30, 2026
What is dupilumab used for?
From the label: indications and usageDUPIXENT is an interleukin-4 receptor alpha antagonist indicated: Atopic Dermatitis for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids. ( 1.1 ) Asthma as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma. ( 1.2 ) Limitations of Use: Not for the relief of acute bronchospasm or status asthmaticus. […]
Conditions named in the indications of dupilumab's FDA labels, with every medicine labeled for each:
From other dupilumab labelsEczema (atopic dermatitis): Atopic Dermatitis DUPIXENT is indicated for the treatment of adult and pediatric patients aged 6 months and older with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies …
Asthma: Asthma DUPIXENT is indicated as an add-on maintenance treatment of adult and pediatric patients aged 6 years and older with moderate-to-severe asthma characterized by an eosinophilic phenotype or with oral corticosteroid dependent asthma.
COPD: Chronic Obstructive Pulmonary Disease DUPIXENT is indicated as an add-on maintenance treatment of adult patients with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype.
Allergies: Chronic Spontaneous Urticaria DUPIXENT is indicated for the treatment of adult and pediatric patients aged 2 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment.
FDA pharmacologic class: Interleukin-4 Receptor alpha Antagonist.
Source: FDA drug label (Dupixent), BLA761055 (Regeneron Pharmaceuticals), as published by Sanofi-Aventis U.S. LLC, effective April 22, 2026 (SPL set 595f437d-2729-40bb-9c62-c8ece1f82780), via openFDA; the full label on DailyMed
Is there a generic for dupilumab (Dupixent)?
No generic dupilumab is approved (Drugs@FDA, October 8, 2026).
- 2017 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for dupilumab (Dupixent)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1,773.74 per mL (Dupixent 200 mg/1.14 mL syring), up 5% from $1,692.10 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.
- Dupixent 300 mg/2 mL pen (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Dupixent 200 mg/1.14 mL pen | Brand | $1,778.86 per mL | $2,027.90 per pen | +5% |
| Dupixent 200 mg/1.14 mL syring | Brand | $1,773.74 per mL | n/a | +5% |
| Dupixent 300 mg/2 mL pen | Brand | $1,009.56 per mL | $2,019.12 per pen | +5% |
| Dupixent 300 mg/2 mL syringe | Brand | $1,010.60 per mL | $2,021.19 per syringe | +5% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What do FAERS reports show for dupilumab?
The FDA Adverse Event Reporting System holds 478,975 reports that list dupilumab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,193 are coded as a death and 22,558 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 rose sharply in 2025 (114,880, against a median of 20,259 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as dupilumab?
3 other medicines are given the same way (subcutaneous) and in the same FDA class as dupilumab or labeled mainly for the same use (eczema (atopic dermatitis)), the same class first. Eczema (atopic dermatitis) lists all 26 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (subcutaneous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Lebrikizumab | Eczema (atopic dermatitis) | none listed | $1,783.52 per mL 250 mg/2 mL pen | No current entry |
| Tralokinumab | Eczema (atopic dermatitis) | none listed | n/a | No current entry |
| Nemolizumab | Eczema (atopic dermatitis) | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to dupilumab
- 3 medicines for the same use
- Dupilumab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other