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FDA Purple Book · Reference family

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. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.

0

Biosimilars

0

Interchangeables

0

Listed patents

2000

Reference approved

Reference product

351(a)BLA 103905

prevnar Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

Wyeth Pharmaceuticals LLC

Approved
Feb 17, 2000
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Approval, exclusivity, and published-patent expiration dates for Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein), in chronological order.

  1. Reference approval

    Approval date of the reference Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) product.

    26 yr 8 mo ago

Frequently asked questions

Are there biosimilars approved for Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) (prevnar)?

No 351(k) biosimilars or interchangeable biosimilars referencing Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) are listed in the FDA Purple Book yet.

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