CliffBio
biologic

OMISIRGE

omidubicel-onlv

Loss of exclusivityApril 2035projected — 12-year biologic exclusivity estimate
CompanyGamida Cell →View the full company profile on CliffBio

Drug detail

Brand nameOMISIRGE
Active ingredientomidubicel-onlv
Strength>4.0x10^8 total viable cells, >2.4x10^7 CD3+ cells with 41mL dil sol; >8.0x10^8 total viable cells, >8.7% CD34+ cells, >9.2x10^7 CD34+ cells with 81mL dil so
Dosage formFor Injection
RouteIntravenous
ModalityBiologic
FDA approvalApril 2023
Marketing statusRx

Source: FDA Purple Book, layered on the CliffBio company graph. Cliff dates are the projected — 12-year biologic exclusivity estimate; estimates are projections, not legal advice.

OMISIRGE patent cliff — loss of exclusivity April 2035 | CliffBio