Respiratory Syncytial Virus Vaccine, Adjuvanted (Arexvy)
Respiratory Syncytial Virus Vaccine, Adjuvanted is an FDA-licensed reference biologic from GlaxoSmithKline Biologicals.
Reference product
Arexvy Respiratory Syncytial Virus Vaccine, Adjuvanted
GlaxoSmithKline Biologicals
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
First licensure
Date Respiratory Syncytial Virus Vaccine, Adjuvanted was first licensed by the FDA.
3 yr 5 mo ago
Reference approval
Approval date of the reference Respiratory Syncytial Virus Vaccine, Adjuvanted product.
3 yr 5 mo ago
Reference exclusivity ends
12-year reference-product exclusivity under the BPCIA.
in 8 yr 9 mo
Respiratory Syncytial Virus Vaccine, Adjuvanted: 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 Respiratory Syncytial Virus Vaccine, Adjuvanted.
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.
