Purple Book reference family · 351(a) biologic
Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq)
Rotavirus Vaccine, Live, Oral, Pentavalent is an FDA-licensed reference biologic from Merck Sharp & Dohme LLC.
351(a) biologicBLA 125122 Merck Sharp & Dohme LLC
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2006
Reference product
Originator biologic
351(a)BLA 125122
Rotateq Rotavirus Vaccine, Live, Oral, Pentavalent
Merck Sharp & Dohme LLC
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 Rotavirus Vaccine, Live, Oral, Pentavalent product.
20 yr 9 mo ago
Rotavirus Vaccine, Live, Oral, Pentavalent: 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, Pentavalent.
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