Prescription medicine
Pirfenidone Brand names: Esbriet
Pirfenidone (Esbriet) is a prescription medicine with an FDA approval on record since 2014. FDA's NDC Directory lists it from 22 generic labelers, and pharmacies paid $0.685 per pirfenidone 267 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the pirfenidone FDA label on DailyMed (effective July 22, 2025, Laurus Labs Limited); the NDA 22535 record on Drugs@FDA; every pirfenidone label on DailyMed.
Highlights of the record
FDA label of July 22, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagePirfenidone is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).
Forms and strengths
- 267 mg
- 534 mg
- 801 mg
Film-coated tablet; coated tablet; capsule; tablet.
On the market
- Earliest approval on file
- October 15, 2014 Esbriet, Legacy; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 23 first January 3, 2022; 20 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 24 of which 22 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- March 28, 2037 Esbriet tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.685 per tablet Pirfenidone 267 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2023 0 Class I among all firms' recalls; latest February 7, 2023
- FAERS reports
- 40,482 through July 30, 2026
What is pirfenidone used for?
From the label: indications and usagePirfenidone is indicated for the treatment of idiopathic pulmonary fibrosis (IPF). Pirfenidone is a pyridone indicated for the treatment of idiopathic pulmonary fibrosis (IPF).
FDA pharmacologic class: Pyridone.
Source: FDA drug label (Pirfenidone), Laurus Labs Limited, effective July 22, 2025 (SPL set 29b0fd0e-5a2b-4da7-8524-177dc28bf55e), via openFDA; the full label on DailyMed
What does the patient leaflet for pirfenidone say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking pirfenidone?Avoid sunlight. Pirfenidone can make your skin sensitive to the sun and the light from sunlamps and tanning beds. You could get a severe sunburn. Use sunscreen (SPF 50) and wear a hat and clothes that cover your skin if you have to be in sunlight. Talk to your doctor if you get sunburn or a rash. • Avoid taking pirfenidone with other medicines that can make your skin sensitive to the sun, the light from sunlamps and tanning beds. • Avoid smoking. Smoking may affect how well pirfenidone works.
From the patient leaflet: How should I store pirfenidone?Store pirfenidone capsules and tablets at room temperature, 77°F (25°C). • Keep in a tightly closed container. Safely throw away any pirfenidone that is out of date or no longer needed. Keep pirfenidone and all medicines out of reach of children.
Source: FDA drug label (Pirfenidone), Laurus Labs Limited, effective July 22, 2025 (SPL set 29b0fd0e-5a2b-4da7-8524-177dc28bf55e), via openFDA; the full label on DailyMed
Is there a generic for pirfenidone (Esbriet)?
The FDA approved the first generic pirfenidone on January 3, 2022. 23 generic applications are approved; 20 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 1 tentative approval: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists pirfenidone from 22 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 16 patents for Esbriet tablets, the last expiring on March 28, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2014 earliest approval on file
- 2022 first generic approved
- 2037 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for pirfenidone (Esbriet)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.685 per Pirfenidone 267 mg tablet, down 48% from $1.33 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. 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.
- Pirfenidone 267 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Pirfenidone 267 mg tablet | Generic | $0.685 per tablet | $20.56 | -48% |
| Pirfenidone 801 mg tablet | Generic | $1.96 per tablet | $58.86 | -47% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has pirfenidone been recalled?
The FDA's Enforcement Report lists 2 recalls naming pirfenidone since 2023: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 7, 2023 | Class II | Accord Healthcare, Inc. | CGMP Deviations: recalling drug products following an FDA inspection. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the pirfenidone label say about other medicines?
The pirfenidone label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name pirfenidone. 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 |
|---|---|---|
| Ciprofloxacin | drug interactions | DRUG INTERACTIONS Moderate (e.g., ciprofloxacin) and strong inhibitors of CYP1A2 (e.g., fluvoxamine) increase systemic exposure of pirfenidone and may alter the adverse reaction profile of pirfenidone. |
| Fluvoxamine | drug interactions | DRUG INTERACTIONS Moderate (e.g., ciprofloxacin) and strong inhibitors of CYP1A2 (e.g., fluvoxamine) increase systemic exposure of pirfenidone and may alter the adverse reaction profile of pirfenidone. |
Source: FDA drug label (Pirfenidone), Laurus Labs Limited, effective July 22, 2025 (SPL set 29b0fd0e-5a2b-4da7-8524-177dc28bf55e), via openFDA; the full label on DailyMed
What do FAERS reports show for pirfenidone?
The FDA Adverse Event Reporting System holds 40,482 reports that list pirfenidone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 9,421 are coded as a death and 7,848 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?
- Pirfenidone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other