Skip to content
Assyro AI
Purple Book reference family · 351(a) biologic

Pneumococcal 20-valent Conjugate Vaccine (Prevnar 20)

Pneumococcal 20-valent Conjugate Vaccine is an FDA-licensed reference biologic from Wyeth Pharmaceuticals LLC.

351(a) biologicBLA 125731 Wyeth Pharmaceuticals LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2021

Reference product

Originator biologic
351(a)BLA 125731

Prevnar 20 Pneumococcal 20-valent Conjugate Vaccine

Wyeth Pharmaceuticals LLC

View full reference-product record
Approved
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Protection horizon
  1. First licensure

    Date Pneumococcal 20-valent Conjugate Vaccine was first licensed by the FDA.

    5 yr 4 mo ago

  2. Reference approval

    Approval date of the reference Pneumococcal 20-valent Conjugate Vaccine product.

    5 yr 4 mo ago

  3. Reference exclusivity ends

    12-year reference-product exclusivity under the BPCIA.

    in 6 yr 10 mo

Pneumococcal 20-valent Conjugate Vaccine: 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 20-valent Conjugate Vaccine.

Related FDA reference tools

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.