bezlotoxumab (Zinplava)
bezlotoxumab 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
2016
Reference approved
Reference product
Zinplava bezlotoxumab
Merck Sharp & Dohme LLC
- Approved
- Oct 21, 2016
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for bezlotoxumab from the RCSB Protein Data Bank (PDB 4NP4).
Interactive biological assembly from PDB entry 4NP4. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here — no need to leave the page.
Exclusivity & patent cliffs
Approval, exclusivity, and published-patent expiration dates for bezlotoxumab, in chronological order.
Reference approval
Approval date of the reference bezlotoxumab product.
9 yr 9 mo ago
Frequently asked questions
Are there biosimilars approved for bezlotoxumab (Zinplava)?
No 351(k) biosimilars or interchangeable biosimilars referencing bezlotoxumab 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.