Purple Book reference family · 351(a) biologic
Meningococcal Groups A, B, C, W and Y Vaccine (PENMENVY)
Meningococcal Groups A, B, C, W and Y Vaccine is an FDA-licensed reference biologic from GlaxoSmithKline Biologicals.
351(a) biologicBLA 125819 GlaxoSmithKline Biologicals
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2025
Reference product
Originator biologic
351(a)BLA 125819
PENMENVY Meningococcal Groups A, B, C, W and Y Vaccine
GlaxoSmithKline Biologicals
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference Meningococcal Groups A, B, C, W and Y Vaccine product.
1 yr 6 mo ago
Meningococcal Groups A, B, C, W and Y 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 Meningococcal Groups A, B, C, W and Y Vaccine.
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.

