Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE)
Pneumococcal 21-valent Conjugate Vaccine is an FDA-licensed reference biologic from Merck Sharp & Dohme LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2024
Reference approved
Reference product
CAPVAXIVE Pneumococcal 21-valent Conjugate Vaccine
Merck Sharp & Dohme LLC
- Approved
- Jun 17, 2024
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Pneumococcal 21-valent Conjugate Vaccine, in chronological order.
Reference exclusivity ends
12-year reference-product exclusivity under the BPCIA.
91 yr 5 mo ago
First licensure
Date Pneumococcal 21-valent Conjugate Vaccine was first licensed by the FDA.
2 yr 1 mo ago
Reference approval
Approval date of the reference Pneumococcal 21-valent Conjugate Vaccine product.
2 yr 1 mo ago
Frequently asked questions
Are there biosimilars approved for Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE)?
No 351(k) biosimilars or interchangeable biosimilars referencing Pneumococcal 21-valent Conjugate Vaccine are listed in the FDA Purple Book yet.
When does Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) lose reference-product exclusivity?
Pneumococcal 21-valent Conjugate Vaccine's 12-year reference-product exclusivity under the BPCIA is listed in the FDA Purple Book as ending June 17, 1936.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.