drug

lefamulin acetate

Marketedupdated 2mo ago

by Nabriva Therapeutics US Inc

Approved

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Patent cliff

source: FDA Orange Book

first barrier falls

Mar 19, 2028

~1.7 years out

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

patents (6)

Jun 14, 2036formulationUS 12121582
Mar 25, 2033compositionUS 8071643
Mar 25, 2033compositionUS 8071643
May 23, 2031compositionUS 91207274.9y
Mar 19, 2028compositionUS 81536891.7y
Mar 19, 2028compositionUS 81536891.7y

FDA exclusivities (4)

Aug 19, 2029GAINGAIN Antibiotic (5y)3.1y
Aug 19, 2029GAINGAIN Antibiotic (5y)3.1y
Aug 19, 2024NCENew Chemical Entity (5y)
Aug 19, 2024NCENew Chemical Entity (5y)

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Data sources

ClinicalTrials.gov

last refreshed 36m ago

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