drug
Ofev
Marketedupdated 3mo agoby Boehringer Ingelheim Corp
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 4indications
investigational
Pulmonary Fibrosis
all catalysts(4)
Trials studying Ofev
- phase3A Study to Evaluate Long-term Safety of Nintedanib in Children and Adolescents With Interstitial Lung Disease (InPedILD®-ON)
- phase1Study to Determine Potential for Drug-drug Interactions When Co-administering Deupirfenidone (LYT-100) and Nintedanib
- —A Study Using a Disease Registry to Observe the Long-term Effects of Nintedanib in People With Scleroderma-related Lung Fibrosis
- —NICEFIT-ON: A Study Under Routine Clinical Practice in Taiwan to Observe the Long-term Outcome of People With Certain Types of Lung Disease (PF-ILD, SSc-ILD, IPF) Who Start Treatment With Nintedanib
- —An Expanded Access Program to Provide Nintedanib to Patients With Non-IPF ILD Who Have no Alternative Treatment Possibilities
- phase1A Study in Healthy Men to Find the Best Formulation for Once Daily Intake of Nintedanib
- phase3Nintedanib for the Treatment of SARS-Cov-2 Induced Pulmonary Fibrosis
Patent cliff
source: FDA Orange Bookfirst barrier falls
Sep 6, 2026
16 days
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (16)
- Dec 7, 2029patentUS 9907756*PED3.3y
- Dec 7, 2029patentUS 9907756*PED3.3y
- Dec 4, 2029patentUS 10105323*PED3.3y
- Dec 4, 2029patentUS 10105323*PED3.3y
- Jun 7, 2029formulationUS 99077562.8y
- Jun 7, 2029formulationUS 99077562.8y
- Jun 4, 2029formulationUS 101053232.8y
- Jun 4, 2029formulationUS 101053232.8y
- Jul 8, 2026patentUS 10154990*PED
- Jul 8, 2026patentUS 10154990*PED
- Apr 1, 2026patentUS 6762180*PED
- Apr 1, 2026patentUS 6762180*PED
- Jan 8, 2026method-of-use (U-2620)US 10154990
- Jan 8, 2026method-of-use (U-2620)US 10154990
- Oct 1, 2025compositionUS 6762180
- Oct 1, 2025compositionUS 6762180
FDA exclusivities (4)
- Mar 6, 2027PEDPediatric (6mo bonus)197d
- Mar 6, 2027PEDPediatric (6mo bonus)197d
- Sep 6, 2026ODE-261Orphan Drug (7y)16d
- Sep 6, 2026ODE-261Orphan Drug (7y)16d
News(2)
- A PureTech startup banks $180M for a new IPF drugCelea, backed by investors such as RA Capital and Leaps by Bayer, is making what it says is an improved version of Roche's Esbriet.biopharma_dive · 1mo ago
- Avalyn, in pursuit of better lung drugs, banks $300M in an IPOThe biotech will use the proceeds to develop inhalable versions of therapies already on the market for the “idiopathic” and “progressive” forms of pulmonary fibrosis.biopharma_dive · 3mo ago
Data sources
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