Respiratory Syncytial Virus Vaccine, Adjuvanted (Arexvy)
Respiratory Syncytial Virus Vaccine, Adjuvanted is an FDA-licensed reference biologic from GlaxoSmithKline Biologicals. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2023
Reference approved
Reference product
Arexvy Respiratory Syncytial Virus Vaccine, Adjuvanted
GlaxoSmithKline Biologicals
- Approved
- May 03, 2023
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Respiratory Syncytial Virus Vaccine, Adjuvanted, in chronological order.
Reference exclusivity ends
12-year reference-product exclusivity under the BPCIA.
92 yr 7 mo ago
First licensure
Date Respiratory Syncytial Virus Vaccine, Adjuvanted was first licensed by the FDA.
3 yr 3 mo ago
Reference approval
Approval date of the reference Respiratory Syncytial Virus Vaccine, Adjuvanted product.
3 yr 3 mo ago
Frequently asked questions
Are there biosimilars approved for Respiratory Syncytial Virus Vaccine, Adjuvanted (Arexvy)?
No 351(k) biosimilars or interchangeable biosimilars referencing Respiratory Syncytial Virus Vaccine, Adjuvanted are listed in the FDA Purple Book yet.
When does Respiratory Syncytial Virus Vaccine, Adjuvanted (Arexvy) lose reference-product exclusivity?
Respiratory Syncytial Virus Vaccine, Adjuvanted's 12-year reference-product exclusivity under the BPCIA is listed in the FDA Purple Book as ending May 3, 1935.
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.