drug

tepotinib hydrochloride

Marketedupdated 2mo ago

by EMD Serono Inc

Approved

community read0 votes

indications

investigational

NSCLC

all catalysts(0)

nothing on the calendar yet

News(0)

no news has mentioned this drug yet

Patent cliff

source: FDA Orange Book

first barrier falls

Feb 3, 2028

~1.6 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 85807813.7y
Oct 30, 2029compositionUS 83296923.3y
Jul 21, 2028method-of-use (U-3078)US 89275402.0y
Jul 4, 2028method-of-use (U-3077)US 86586432.0y
Jul 4, 2028formulationUS 90620292.0y
Jul 4, 2028method-of-use (U-3077)US 94037992.0y
May 30, 2028compositionUS 89213571.9y
Apr 29, 2028formulationUS 92843001.8y

FDA exclusivities (2)

Feb 3, 2028ODE-325Orphan Drug (7y)1.6y
Feb 3, 2026NCENew Chemical Entity (5y)

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Data sources

ClinicalTrials.gov

last refreshed 1h ago

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