Prescription medicine
Nintedanib Brand names: Ofev
Nintedanib (Ofev) is a prescription medicine with an FDA approval on record since 2014. FDA's NDC Directory lists it from 11 generic labelers, and pharmacies paid $13.46 per nintedanib esylate 150 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the nintedanib FDA label on DailyMed (effective November 20, 2025, Boehringer Ingelheim Pharmaceuticals, Inc.); the NDA 205832 record on Drugs@FDA; every nintedanib label on DailyMed.
Highlights of the record
FDA label of November 20, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageOFEV is a kinase inhibitor indicated in adults for: Treatment of idiopathic pulmonary fibrosis (IPF) ( 1.1 ) Treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype ( 1.2 ) Slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) ( 1.3 ) 1.1 Idiopathic Pulmonary Fibrosis OFEV is indicated for the treatmen
Forms and strengths
- 100 mg
- 150 mg
Capsule.
On the market
- Earliest approval on file
- October 15, 2014 Ofev, Boehringer Ingelheim; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 9 first April 2, 2026; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 12 of which 11 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 7, 2029 Ofev capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $13.46 per capsule Nintedanib esylate 150 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 31,339 through July 30, 2026
What is nintedanib used for?
From the label: indications and usageOFEV is a kinase inhibitor indicated in adults for: Treatment of idiopathic pulmonary fibrosis (IPF) ( 1.1 ) Treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype ( 1.2 ) Slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) ( 1.3 ) 1.1 Idiopathic Pulmonary Fibrosis OFEV is indicated for the treatment of adults with idiopathic pulmonary fibrosis (IPF). 1.2 Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype OFEV is indicated for the treatment of adults with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype [see Clinical Studies (14.2) ]. 1.3 Systemic Sclerosis-Associated Interstitial Lung Disease OFEV is indicated to slow the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). […]
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (Ofev), Boehringer Ingelheim Pharmaceuticals, Inc., effective November 20, 2025 (SPL set da1c9f37-779e-4682-816f-93d0faa4cfc9), via openFDA; the full label on DailyMed
What does the patient leaflet for nintedanib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about OFEV?OFEV can cause birth defects or death to an unborn baby. Women should not become pregnant while taking OFEV. Women who are able to become pregnant should have a pregnancy test before starting treatment with OFEV. Women who are able to become pregnant should use highly effective birth control at the start of treatment, during treatment, and for at least 3 months after treatment. Talk with your doctor about what birth control method is right for you during this time. Birth control pills may not work as well in women having vomiting, diarrhea, or other problems reducing the drug absorption. If you have any of these problems, talk with your doctor about which highly effective birth control method is right for you. If you become pregnant or think you are pregnant while taking OFEV, tell your doctor right away. What is OFEV? OFEV is a prescription medicine used: to treat adults with a lung disease called idiopathic pulmonary fibrosis (IPF). to treat adults with a long-lasting (chronic) interstitial lung disease in which lung fibrosis continues to worsen (progress). to slow the rate of decline in lung function in adults with systemic sclerosis-associated interstitial lung disease (SSc-ILD) (also known as scleroderma-associated ILD). It is not known if OFEV is safe and effective in children.
From the patient leaflet: How should I store OFEV?Store OFEV at room temperature between 68°F to 77°F (20°C to 25°C). Keep OFEV dry and protect from high heat. Keep OFEV and all medicines out of the reach of children.
Source: FDA drug label (Ofev), Boehringer Ingelheim Pharmaceuticals, Inc., effective November 20, 2025 (SPL set da1c9f37-779e-4682-816f-93d0faa4cfc9), via openFDA; the full label on DailyMed
Is there a generic for nintedanib (Ofev)?
The FDA approved the first generic nintedanib on April 2, 2026. 9 generic applications are approved; 9 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 5 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists nintedanib from 11 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 4 patents for Ofev capsules: the compound patent runs to October 1, 2025 (pediatric exclusivity to April 1, 2026), and the last listed entry to December 7, 2029. 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
- 2026 first generic approved
- 2029 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for nintedanib (Ofev)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $13.46 per Nintedanib esylate 150 mg capsule. 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.
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Nintedanib esylate 150 mg capsule | Generic | $13.46 per capsule | $403.69 | n/a |
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 nintedanib label say about other medicines?
The nintedanib label names 8 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name nintedanib. 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 |
|---|---|---|
| Bosentan | drug interactions | Coadministration of nintedanib with bosentan did not alter the pharmacokinetics of nintedanib [see Clinical Pharmacology (12.3) ]. |
| Carbamazepine | drug interactions | Concomitant use of P-gp and CYP3A4 inducers (e.g., carbamazepine, phenytoin, and St. John's wort) with OFEV should be avoided as these drugs may decrease exposure to nintedanib [see Clinical Pharmacology (12.3) ]. |
| Erythromycin | drug interactions | Concomitant use of P-gp and CYP3A4 inhibitors (e.g., erythromycin) with OFEV may increase exposure to nintedanib [see Clinical Pharmacology (12.3) ]. |
| Ketoconazole | drug interactions | Coadministration with oral doses of a P-gp and CYP3A4 inhibitor, ketoconazole, increased exposure to nintedanib by 60%. |
| Levonorgestrel | warnings and precautions | Nintedanib does not change the exposure to oral contraceptive containing ethinylestradiol and levonorgestrel in patients with SSc-ILD. |
| Loperamide | warnings and precautions | Treat diarrhea at first signs with adequate hydration and antidiarrheal medication (e.g., loperamide), and consider dose reduction or treatment interruption if diarrhea continues [see Dosage and Administration (2.4) ]. |
| Phenytoin | drug interactions | Concomitant use of P-gp and CYP3A4 inducers (e.g., carbamazepine, phenytoin, and St. John's wort) with OFEV should be avoided as these drugs may decrease exposure to nintedanib [see Clinical Pharmacology (12.3) ]. |
| Pirfenidone | drug interactions | In a multiple-dose study conducted to assess the pharmacokinetic effects of concomitant treatment with nintedanib and pirfenidone, the coadministration of nintedanib with pirfenidone did not alter the exposure of either agent [see Clinical Pharmacology (12.3) ]. |
Other labels that name nintedanib
Source: FDA drug label (Ofev), Boehringer Ingelheim Pharmaceuticals, Inc., effective November 20, 2025 (SPL set da1c9f37-779e-4682-816f-93d0faa4cfc9), via openFDA; the full label on DailyMed
What do FAERS reports show for nintedanib?
The FDA Adverse Event Reporting System holds 31,339 reports that list nintedanib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6,218 are coded as a death and 10,549 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
- Nintedanib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other