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Purple Book reference family · 351(a) biologic

Zoster Vaccine Recombinant, Adjuvanted (Shingrix)

Zoster Vaccine Recombinant, Adjuvanted is an FDA-licensed reference biologic from GlaxoSmithKline Biologicals.

351(a) biologicBLA 125614 GlaxoSmithKline Biologicals
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2017

Reference product

Originator biologic
351(a)BLA 125614

Shingrix Zoster Vaccine Recombinant, Adjuvanted

GlaxoSmithKline Biologicals

View full reference-product record
Approved
Marketing
Rx
Center
CBER
Patents
None listed

Exclusivity & patent cliffs

Protection horizon
  1. Reference approval

    Approval date of the reference Zoster Vaccine Recombinant, Adjuvanted product.

    8 yr 11 mo ago

Zoster Vaccine Recombinant, 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 Zoster Vaccine Recombinant, Adjuvanted.

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Agent CTA Background

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