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Hyrnuo · pharmadog

pharmadog
drugs
Hyrnuo

drug · small molecule

patient view →

sevabertinib

Marketedupdated 2mo ago

by Bayer AG🔗 ChEMBL

Approved

community read0 votes

Small molecule drug with a maximum clinical stage of Unknown, with 1 investigational indication.

indications

investigational

NSCLC

all catalysts(1)

approval · 1

News(0)

no news has mentioned this drug yet

brand

Hyrnuo

generic

sevabertinib

indication

Non-Small Cell Lung Cancer

phase

marketed

HYRNUO (SEVABERTINIB) — FDA approval

Patent cliff

source: FDA Orange Book

first barrier falls

Nov 19, 2030

~4.4 years out

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (1)

Oct 10, 2035compositionUS 10428063

FDA exclusivities (1)

Nov 19, 2030NCENew Chemical Entity (5y)4.4y

Data sources

openFDA · ClinicalTrials.gov · OpenTargets

last refreshed 2h ago

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🐶 often sniffed alongside

top 3

drugHYRNUO4 co-mentions · 1 sources
tagApproval4 co-mentions · 1 sources
tagSmall Molecule2 co-mentions · 1 sources

Trials studying sevabertinib

phase3A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)recruitingn=444
—Expanded Access to Provide Sevabertinib (BAY 2927088) for the Treatment of Locally Advanced or Metastatic NSCLC With HER2 Mutationavailable
phase1A Study Evaluating How Moderate Liver Impairment Affects the Absorption, Distribution, Metabolism, and Elimination of Sevabertinib After a Single Oral Dosecompletedn=18