biologic

Comirnaty

COVID-19 Vaccine, mRNA

Loss of exclusivityAugust 2037projected — 12-year biologic exclusivity estimate
CompanyBioNTech Manufacturing GmbH

Drug detail

Brand nameComirnaty
Active ingredientCOVID-19 Vaccine, mRNA
Strength10UG/0.3ML
Dosage formFor Injection
RouteIntramuscular
ModalityBiologic
FDA approvalAugust 2025
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.

Comirnaty patent cliff — loss of exclusivity August 2037 | CliffBio