Purple Book reference family · 351(a) biologic
COVID-19 Vaccine, mRNA (Comirnaty)
COVID-19 Vaccine, mRNA is an FDA-licensed reference biologic from BioNTech Manufacturing GmbH.
351(a) biologicBLA 125742 BioNTech Manufacturing GmbH
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2025
Reference product
Originator biologic
351(a)BLA 125742
Comirnaty COVID-19 Vaccine, mRNA
BioNTech Manufacturing GmbH
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference COVID-19 Vaccine, mRNA product.
11 mo ago
COVID-19 Vaccine, mRNA: frequently asked questions
Reference exclusivity, biosimilars, interchangeability, and patents for this molecule, from the FDA Purple Book.
Built from official FDA Purple Book records (monthly downloads, the Advanced Search interface, and the published Patent List), with reference-product, license-type, and exclusivity context for COVID-19 Vaccine, mRNA.
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