Help paying · Medicare negotiated price · pharmacy cost · cycle 2027
Ofev (nintedanib): where help paying exists, what Medicare negotiated and what pharmacies pay
A program that covered this drug has changed its terms; the details and the source are below. Medicare's negotiated price for a 30-day supply is $6,350 on January 1, 2027. ClinicalTrials.gov lists 9 recruiting trials that name nintedanib.
Every package we can price
Per-unit prices (per unit, as the files state). "Scheduled" is a price the CMS file already dates for the future.
| NDC | Product | Unit | Negotiated now | Scheduled | NADAC | Share |
|---|---|---|---|---|---|---|
| 00597-0143-60 | Ofev (nintedanib) 100mg | n/a | n/a | $109 | n/a | no NADAC price |
| 00597-0145-60 | Ofev (nintedanib) 150mg | n/a | n/a | $109 | n/a | no NADAC price |
When could a generic arrive
Each date below is an upper bound from listed patent and exclusivity dates, not a forecast of when a generic will launch. Basis: latest of all listed patent and exclusivity expiries in this Orange Book edition; an upper bound from listed dates only, not a forecast of launch (litigation, settlements, delisting, tentative approvals and 180-day status are not modelled).
| Application | Product | Latest listed patent expiry | Latest listed exclusivity expiry | Latest of the two | Set by |
|---|---|---|---|---|---|
| NDA205832 | Ofev (nintedanib) 100mg, Ofev (nintedanib) 150mg | December 7, 2029 | March 6, 2027 | December 7, 2029 | patent 9907756 with its pediatric extension; 20 dated entries listed |
Source: FDA Orange Book data files, edition September 2026, read November 7, 2026; patent listings are as submitted by applicants and not verified by FDA. FDA data file.
Medicare Part D spending
CMS's Medicare Part D spending dataset reports gross spending on Ofev of $2.09 billion in 2024, across 161,717 claims and 23,929 beneficiaries. CMS's dataset states spending is gross drug cost and does not reflect manufacturers' rebates or other price concessions. Spending is the total paid by Medicare, plans and beneficiaries for the drug's claims, not what a patient pays.
| Year | Gross spending | Claims | Beneficiaries | Average spending per claim |
|---|---|---|---|---|
| 2024 | $2.09 billion | 161,717 | 23,929 | $12,902 |
| 2023 | $1.84 billion | 140,681 | 20,444 | $13,058 |
| 2022 | $1.76 billion | 143,756 | 20,686 | $12,264 |
| 2021 | $1.50 billion | 129,070 | 19,476 | $11,584 |
| 2020 | $1.16 billion | 105,327 | 15,902 | $10,990 |
Source: CMS Medicare Part D spending by drug (data-year-2024, modified 2026-06-25), read November 7, 2026. CMS dataset page. All manufacturers combined; the figures are a drug-level aggregate of claims and say nothing about a formulary or coverage.
Rare-disease (orphan) designations
The FDA's orphan drug database lists 3 designations for Nintedanib; nintedanib, 2 with an approval recorded. A designation is not an approval and not a statement that the drug treats the condition; the status column is the database's own.
| Designated | Designated use | Status | Sponsor |
|---|---|---|---|
| December 12, 2016 | Treatment of mesothelioma | Designated | Boehringer Ingelheim Pharmaceuticals, Inc. |
| July 6, 2016 | Treatment of systemic sclerosis (including the associated interstitial lung disease). | Designated/Approved | Boehringer Ingelheim Pharmaceuticals, Inc. |
| June 29, 2011 | Treatment of patients with idiopathic pulmonary fibrosis. | Designated/Approved | Boehringer Ingelheim Pharmaceuticals, Inc. |
Source: FDA Orphan Drug Designations and Approvals database, read November 7, 2026. FDA orphan drug search.
Medicaid use by state
CMS's State Drug Utilization Data records, for 2025, how many prescriptions each state's Medicaid program paid for under this drug's packages and what it reimbursed. The 3 states with the largest reimbursement are shown. Reimbursement is before the rebates manufacturers pay states, so it is not a net cost and not a price a patient pays.
| State | Medicaid-paid prescriptions | Medicaid reimbursed | Covers |
|---|---|---|---|
| VA | 70 | $911,674 | Fee-for-service only |
| OK | 67 | $905,079 | Fee-for-service only |
| MN | 56 | $749,776 | Fee-for-service only |
Where the publisher suppresses small managed-care cells, a state's figure covers fee-for-service claims only and understates use (3 state and package figures are marked that way here). A state missing from the table means its figures were suppressed or not reported, not zero use. 43 older-year figures are held and left out of the table.
Source: CMS State Drug Utilization Data (State Drug Utilization Data 2025, modified 2026-07-13T15:28:32Z), read November 7, 2026. CMS dataset page. State-reported data compiled by CMS; aggregate by state and package, no provider or patient data.
Where help paying exists
No program in our finder currently lists this drug as open to new patients.
Label changes
The FDA file lists no non-manufacturing label change for these applications since November 11, 2025. The most recent one it lists is dated October 11, 2024 (Labeling).
Source: FDA Drugs@FDA data file, read November 7, 2026. Dates are the FDA action dates; the documents are on FDA's own site. FDA data file. All recent changes across these drugs: label changes feed.
Clinical trials recruiting
ClinicalTrials.gov lists 9 interventional trials that name nintedanib and are recruiting, and 6 more not yet recruiting. By phase: Phase 2: 4, Phase 3: 3, Phase 1: 1, PHASE1/PHASE2: 1. The 9 most recently updated are below. A listing is not an offer of free drug and not medical advice. Whether a trial fits is decided by the study team and your own clinician.
| Trial | Title and conditions | Phase | Lead sponsor | Last updated | Countries |
|---|---|---|---|---|---|
| NCT07194382 | AURA-IPF: A Randomized Phase 2 Study to Evaluate the Safety and Efficacy of AP02 (Nintedanib Solution) in IPFIdiopathic Pulmonary Fibrosis (IPF) | Phase 2 | Avalyn Pharma Inc. | October 15, 2026 | Australia, Canada, Germany and 4 more |
| NCT07679893 | Phase 2 Clinical Trial of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis (IPF) | Phase 2 | Mannkind Corporation | September 14, 2026 | Canada |
| NCT07454291 | A Study to Evaluate Pharmacokinetics and Drug-drug Interactions of ENV-101 (Taladegib) in Healthy ParticipantsIdiopathic Pulmonary Fibrosis | Phase 1 | Endeavor Biomedicines, Inc. | May 15, 2026 | Australia |
| NCT06297096 | Study of the Efficacy of Nintedanib+Tocilizumab in Patients With Systemic Sclerosis and Interstitial Lung DiseaseSystemic Sclerosis; Interstitial Lung Disease | Phase 3 | National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland | April 8, 2026 | Poland |
| NCT07299695 | Intravenous Immunoglobulin for the Treatment of Acute Exacerbations of Idiopathic Pulmonary FibrosisIdiopathic Pulmonary Fibrosis; Acute Exacerbation of Idiopathic Pulmonary Fibrosis | Phase 3 | Argyrios Tzouvelekis | March 16, 2026 | Greece |
| NCT04976036 | Efficacy of Nintedanib for Treatment of Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT) PatientsTelangiectasia, Hereditary Hemorrhagic | Phase 2 | Dr. Romain Lazor | March 11, 2026 | France, Switzerland |
| NCT05674994 | Glucocorticoids Versus Placebo for the Treatment of Acute Exacerbation of Idiopathic Pulmonary FibrosisAcute Exacerbation of Idiopathic Pulmonary Fibrosis | Phase 3 | Fondation Hôpital Saint-Joseph | March 2, 2026 | France |
| NCT06742502 | Sintilimab Plus Rituximab Followed by R-CHOP Regimen in Untreated PMBLPrimary Mediastinal Diffuse Large B-cell Lymphoma | Phase 2 | Sun Yat-sen University | June 5, 2025 | China |
| NCT06071013 | Nintedanib Plus EGFR TKI In EGFR-mutated Non-small Cell Lung Cancer PatientsNon-small Cell Lung Cancer; EGFR Gene Mutation; EGFR-TKI Resistant Mutation | Phase 1 / Phase 2 | China Medical University Hospital | January 23, 2025 | Taiwan |
Source: ClinicalTrials.gov, registry data processed November 6, 2026, summarized and trimmed by OmniRx. Search on ClinicalTrials.gov.
Questions
What is the Medicare negotiated price of Ofev?
The CMS file publishes $6,350 from January 1, 2027. This is a price CMS agreed with the manufacturer for Medicare Part D, not what a person pays at the counter.
How does the negotiated price compare with what pharmacies pay?
The two CMS files do not give a comparable per-unit price for this drug.
Is there help paying for Ofev?
No program in our finder currently lists it as open to new patients. No new patient enrollments for individuals with Medicare Part D or Medicare Advantage prescription drug coverage for Boehringer Ingelheim primary care products (Combivent Respimat, Glyxambi, Jardiance, Jentadueto, Jentadueto XR, Spiriva Respimat, Stiolto Respimat, Synjardy, Synjardy XR, Tradjenta, Trijardy XR). Part D patients actively enrolled as of 2026-10-15 continue through their current enrollment period and may be eligible in 2027 only after annual re-enrollment. Product removals: Cyltezo 2026-07-15; OFEV 2026-09-11 (active patients continue through the end of their enrollment or 2027-12-31); no new enrollments for Aptivus, Atrovent and Striverdi from 2026-10-15.
When could a generic version of Ofev arrive?
For Ofev, the FDA's Orange Book (edition September 2026) lists these latest patent or exclusivity expiry dates by application: NDA205832, December 7, 2029. Each date is an upper bound from listed patent and exclusivity dates, not a forecast of when a generic will launch. Basis: latest of all listed patent and exclusivity expiries in this Orange Book edition; an upper bound from listed dates only, not a forecast of launch (litigation, settlements, delisting, tentative approvals and 180-day status are not modelled).
Can I join a clinical trial for Ofev?
ClinicalTrials.gov lists 9 recruiting interventional trials that name nintedanib (registry data processed November 6, 2026). A listing is not an offer of free drug and not medical advice. Whether a trial fits is decided by the study team and your own clinician.
How much does Medicare Part D spend on Ofev?
CMS's Medicare Part D spending dataset reports gross spending on Ofev of $2.09 billion in 2024, across 161,717 claims and 23,929 beneficiaries. CMS's dataset states spending is gross drug cost and does not reflect manufacturers' rebates or other price concessions. Spending is the total paid by Medicare, plans and beneficiaries for the drug's claims, not what a patient pays.
For developers: this drug as data
One call returns price, generic-entry upper bound, label history, recalls, trials, assistance, and where facts exist the FDA safety program (REMS), DEA schedule, orphan designations, safety notices and Medicaid use by state, each with receipts.
Example file: https://omnirx.org/api/v1/dossier/ofev.json
The licence page sets out what a data licence covers, and the API page documents these files.
Evaluation files with receipts; contract may change; not clinical advice.
Sources and terms. CMS Medicare Drug Price Negotiation Program data file (read November 6, 2026; the CMS page states no licence or restriction); CMS NADAC from data.medicaid.gov under the labels in the OmniRx licence ledger; program details read from each program's own pages; CMS Medicare Part D spending by drug; FDA Drugs@FDA and Orange Book data files; ClinicalTrials.gov registry data. Figures are stored with their sources in the OmniRx library (edition 2026-11). Free to cite with attribution. Not medical, legal or financial advice. Report an error through the contact page. Licence the data.