drug

ceftobiprole medocaril

Marketedupdated 2mo ago

by Innoviva Specialty Therapeutics Inc

Approved

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ClinicalTrials.gov

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Patent cliff

source: FDA Orange Book

first barrier falls

Apr 3, 2029

~2.7 years out

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

FDA exclusivities (2)

Apr 3, 2034GAINGAIN Antibiotic (5y)
Apr 3, 2029NCENew Chemical Entity (5y)2.7y

Trials studying ceftobiprole medocaril

phase3Late-onset Sepsis in Term and Pre-term Neonates and Infants up to 3 Months of Agecompletedn=9
phase3Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremiacompletedn=390
—Collection of Data of Ceftobiprole Treated Patients: Comparison of Patients With and Without Certain Diseasescompletedn=428
phase1Pharmacokinetics and Safety of Ceftobiprole in Neonates and Infants up to 3 Months Treated With Systemic Antibioticsterminatedn=15