Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE)
Pneumococcal 21-valent Conjugate Vaccine is an FDA-licensed reference biologic from Merck Sharp & Dohme LLC.
Reference product
CAPVAXIVE Pneumococcal 21-valent Conjugate Vaccine
Merck Sharp & Dohme LLC
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
First licensure
Date Pneumococcal 21-valent Conjugate Vaccine was first licensed by the FDA.
2 yr 4 mo ago
Reference approval
Approval date of the reference Pneumococcal 21-valent Conjugate Vaccine product.
2 yr 4 mo ago
Reference exclusivity ends
12-year reference-product exclusivity under the BPCIA.
in 9 yr 11 mo
Pneumococcal 21-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 21-valent Conjugate Vaccine.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
