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. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2010
Reference approved
Reference product
Prevnar 13 Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
Wyeth Pharmaceuticals LLC
- Approved
- Feb 24, 2010
- Marketing
- Disc
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein), in chronological order.
Reference approval
Approval date of the reference Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) product.
16 yr 6 mo ago
Frequently asked questions
Are there biosimilars approved for Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) (Prevnar 13)?
No 351(k) biosimilars or interchangeable biosimilars referencing Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) are listed in the FDA Purple Book yet.
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