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  1. pharmadog
  2. ›drugs
  3. ›Ensacove
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ensartinib hydrochloride

Marketedupdated 3mo ago
by Xcovery Holdings Inc
Approved
community read0 votes

🐶 often sniffed alongside

top 3
  • drugENSACOVE12 co-mentions · 3 sources
  • tagApproval12 co-mentions · 3 sources
  • tagSmall Molecule6 co-mentions · 3 sources

indications

investigational
NSCLC

all catalysts(3)

approval · 3
Dec 18, 2024
approval
2y ago
ENSACOVE (ENSARTINIB HYDROCHLORIDE) — FDA approval
ensartinib hydrochloride
→
Jan 8, 2026
approval
7mo ago
ENSACOVE (ENSARTINIB HYDROCHLORIDE) — FDA approval
ensartinib hydrochloride
→
Feb 26, 2026
approval
6mo ago
ENSACOVE (ENSARTINIB HYDROCHLORIDE) — FDA approval
ensartinib hydrochloride
→

Trials studying ensartinib hydrochloride

  • phase1A Single Dose BE Study of X-396 in Healthy Volunteers Under Fasted Conditionscompletedn=32

Patent cliff

source: FDA Orange Book
first barrier falls
Feb 9, 2029
~2.5 years out

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

patents (8)

  • Jun 1, 2037compositionUS 10899744
  • Jun 1, 2037compositionUS 10899744
  • Nov 29, 2031compositionUS 9126947
  • Nov 29, 2031compositionUS 9126947
  • Jun 18, 2029compositionUS 92967242.8y
  • Jun 18, 2029compositionUS 92967242.8y
  • Feb 9, 2029compositionUS 85519952.5y
  • Feb 9, 2029compositionUS 85519952.5y

FDA exclusivities (2)

  • Dec 18, 2029NCENew Chemical Entity (5y)3.3y
  • Dec 18, 2029NCENew Chemical Entity (5y)3.3y

News(0)

no news has mentioned this drug yet

brand
Ensacove
generic
ensartinib hydrochloride
indication
Non-Small Cell Lung Cancer
phase
marketed
Data sources
openFDA · ClinicalTrials.gov
last refreshed 6m ago
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