Purple Book reference family · 351(a) biologic
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) (Prevnar 13)
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) is an FDA-licensed reference biologic from Wyeth Pharmaceuticals LLC.
351(a) biologicBLA 125324 Wyeth Pharmaceuticals LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2010
Reference product
Originator biologic
351(a)BLA 125324
Prevnar 13 Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
Wyeth Pharmaceuticals LLC
View full reference-product record- Approved
- Marketing
- Disc
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) product.
16 yr 8 mo ago
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein): 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 Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein).
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