biologic

Spikevax

COVID-19 Vaccine, mRNA

Loss of exclusivitySeptember 2035projected — 12-year biologic exclusivity estimate
CompanyModernaTX, Inc.

Drug detail

Brand nameSpikevax
Active ingredientCOVID-19 Vaccine, mRNA
Strength50UG/0.5mL
Dosage formInjection
RouteIntramuscular
ModalityBiologic
FDA approvalSeptember 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.

Spikevax patent cliff — loss of exclusivity September 2035 | CliffBio