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Ofev · pharmadog

pharmadog
drugs
Ofev

drug

patient view →

Ofev

Marketedupdated 2mo ago

by Boehringer Ingelheim Corp

Approved

community read0 votes

indications

investigational

Pulmonary Fibrosis

all catalysts(4)

approval · 4

NINTEDANIB ESYLATE — FDA approval

NINTEDANIB ESYLATE — FDA approval

NINTEDANIB ESYLATE — FDA approval

NINTEDANIB ESYLATE — FDA approval

News(0)

no news has mentioned this drug yet

brand

Ofev

generic

nintedanib esylate

indication

Systemic Sclerosis (Scleroderma)

phase

marketed

Patent cliff

source: FDA Orange Book

first barrier falls

Jul 8, 2026

1 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*PED3.4y
Dec 7, 2029patentUS 9907756*PED3.4y
Dec 4, 2029patentUS 10105323*PED3.4y
Dec 4, 2029patentUS 10105323*PED3.4y
Jun 7, 2029formulationUS 99077562.9y
Jun 7, 2029formulationUS 99077562.9y
Jun 4, 2029formulationUS 101053232.9y
Jun 4, 2029formulationUS 101053232.9y
Jul 8, 2026patentUS 10154990*PED1d
Jul 8, 2026patentUS 10154990*PED1d
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)242d
Mar 6, 2027PEDPediatric (6mo bonus)242d
Sep 6, 2026ODE-261Orphan Drug (7y)61d
Sep 6, 2026ODE-261Orphan Drug (7y)61d

Data sources

openFDA · ClinicalTrials.gov

last refreshed 1h ago

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🐶 often sniffed alongside

top 4

tagApproval10 co-mentions · 5 sources
drugnintedanib5 co-mentions · 5 sources
drugNINTEDANIB ESYLATE5 co-mentions · 5 sources
tagSmall Molecule5 co-mentions · 5 sources

Trials studying Ofev

phase3A Study to Evaluate Long-term Safety of Nintedanib in Children and Adolescents With Interstitial Lung Disease (InPedILD®-ON)completedn=54
phase1Study to Determine Potential for Drug-drug Interactions When Co-administering Deupirfenidone (LYT-100) and Nintedanibcompletedn=24
—A Study Using a Disease Registry to Observe the Long-term Effects of Nintedanib in People With Scleroderma-related Lung Fibrosisactive not recruitingn=2,000
—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 Nintedanibcompletedn=214
—An Expanded Access Program to Provide Nintedanib to Patients With Non-IPF ILD Who Have no Alternative Treatment Possibilitiesapproved for marketing
phase1A Study in Healthy Men to Find the Best Formulation for Once Daily Intake of Nintedanibcompletedn=21
phase3Nintedanib for the Treatment of SARS-Cov-2 Induced Pulmonary Fibrosisrecruitingn=250