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OFEV®
OFEV® is a marketed drug by Boehringer Ingelheim, primarily indicated for idiopathic pulmonary fibrosis, with a key composition patent expiring in 2028. Its key strength lies in its established market presence and specific mechanism of action targeting a critical biological pathway. The primary risk is the competitive landscape, including off-patent drugs like sunitinib and pazopanib, which may erode market share.
At a glance
| Generic name | OFEV® |
|---|---|
| Also known as | Nintedanib |
| Sponsor | Boehringer Ingelheim |
| Drug class | Kinase Inhibitor |
| Target | Calcium/calmodulin-dependent protein kinase type IV, Cyclin-dependent kinase 18, Cyclin-dependent kinase-like 2 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Approved indications
- Idiopathic pulmonary fibrosis
- Interstitial fibrosis
- Non-small cell lung cancer
- Systemic sclerosis associated interstitial lung disease
Common side effects
- Diarrhea
- Nausea
- Abdominal pain
- Vomiting
- Liver enzyme elevation
- Decreased appetite
- Headache
- Weight decreased
- Hypertension
- Hypothyroidism
- Alopecia
Serious adverse events
- Myocardial infarction
- Bronchitis
- Pneumonia
- Lung neoplasm malignant
Key clinical trials
- Efficacy and Safety of Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD) (PHASE3)
- A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis (PHASE3)
- Safety And Efficacy of BIBF 1120 in Idiopathic Pulmonary Fibrosis (PHASE2)
- Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients (PHASE3)
- Safety and Efficacy of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients II (PHASE3)
- Correlation Between Changes in Lung Function and Changes in Cough and Dyspnoea in Nintedanib-treated Connective Tissue Disease Interstitial Lung Disease (CTD-ILD) Patients
- Double Immunosuppression With or Without Anti-fibrotic in Scleroderma ILD
- A Prospective, Multicenter Exploratory Clinical Study on Consolidation Therapy With Tislelizumab Combined With Nintedanib for Limited-stage Small Cell Lung Cancer (PHASE4)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- OFEV® CI brief — competitive landscape report
- OFEV® updates RSS · CI watch RSS
- Boehringer Ingelheim portfolio CI