Purple Book reference family · 351(a) biologic
Rotavirus Vaccine, Live, Oral (Rotarix)
Rotavirus Vaccine, Live, Oral is an FDA-licensed reference biologic from GlaxoSmithKline Biologicals.
351(a) biologicBLA 125265 GlaxoSmithKline Biologicals
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2022
Reference product
Originator biologic
351(a)BLA 125265
Rotarix Rotavirus Vaccine, Live, Oral
GlaxoSmithKline Biologicals
View full reference-product record- Approved
- Marketing
- Disc
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference Rotavirus Vaccine, Live, Oral product.
3 yr 9 mo ago
Rotavirus Vaccine, Live, Oral: 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 Rotavirus Vaccine, Live, Oral.
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