Rotavirus Vaccine, Live, Oral (Rotarix)
Rotavirus Vaccine, Live, Oral 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
2022
Reference approved
Reference product
Rotarix Rotavirus Vaccine, Live, Oral
GlaxoSmithKline Biologicals
- Approved
- Nov 04, 2022
- Marketing
- Disc
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Rotavirus Vaccine, Live, Oral, in chronological order.
Reference approval
Approval date of the reference Rotavirus Vaccine, Live, Oral product.
3 yr 8 mo ago
Frequently asked questions
Are there biosimilars approved for Rotavirus Vaccine, Live, Oral (Rotarix)?
No 351(k) biosimilars or interchangeable biosimilars referencing Rotavirus Vaccine, Live, Oral are listed in the FDA Purple Book yet.
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