Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq)
Rotavirus Vaccine, Live, Oral, Pentavalent is an FDA-licensed reference biologic from Merck Sharp & Dohme LLC. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2006
Reference approved
Reference product
Rotateq Rotavirus Vaccine, Live, Oral, Pentavalent
Merck Sharp & Dohme LLC
- Approved
- Feb 03, 2006
- Marketing
- Rx
- Center
- CBER
- Patents
- None listed
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for Rotavirus Vaccine, Live, Oral, Pentavalent, in chronological order.
Reference approval
Approval date of the reference Rotavirus Vaccine, Live, Oral, Pentavalent product.
20 yr 7 mo ago
Frequently asked questions
Are there biosimilars approved for Rotavirus Vaccine, Live, Oral, Pentavalent (Rotateq)?
No 351(k) biosimilars or interchangeable biosimilars referencing Rotavirus Vaccine, Live, Oral, Pentavalent are listed in the FDA Purple Book yet.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.