Purple Book reference family · 351(a) biologic
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) (prevnar)
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) is an FDA-licensed reference biologic from Wyeth Pharmaceuticals LLC.
351(a) biologicBLA 103905 Wyeth Pharmaceuticals LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2000
Reference product
Originator biologic
351(a)BLA 103905
prevnar Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
Wyeth Pharmaceuticals LLC
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 Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) product.
26 yr 10 mo ago
Pneumococcal 7-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 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein).
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