drug
tepotinib hydrochloride
Marketedupdated 3mo agoby EMD Serono Inc
Approvedcommunity read0 votes
indications
investigational
NSCLC
all catalysts(0)
nothing on the calendar yet
Patent cliff
source: FDA Orange Bookfirst barrier falls
Feb 3, 2028
~1.5 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)
- Mar 19, 2030compositionUS 85807813.6y
- Oct 30, 2029compositionUS 83296923.2y
- Jul 21, 2028method-of-use (U-3078)US 89275401.9y
- Jul 4, 2028method-of-use (U-3077)US 86586431.9y
- Jul 4, 2028formulationUS 90620291.9y
- Jul 4, 2028method-of-use (U-3077)US 94037991.9y
- May 30, 2028compositionUS 89213571.8y
- Apr 29, 2028formulationUS 92843001.7y
FDA exclusivities (2)
- Feb 3, 2028ODE-325Orphan Drug (7y)1.5y
- Feb 3, 2026NCENew Chemical Entity (5y)
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