ipilimumab (Yervoy)
ipilimumab is an FDA-licensed reference biologic from Bristol-Myers Squibb Company. Reference exclusivity, biosimilar lineage, and published patents from official FDA Purple Book records.
0
Biosimilars
0
Interchangeables
0
Listed patents
2011
Reference approved
Reference product
Yervoy ipilimumab
Bristol-Myers Squibb Company
- Approved
- Mar 25, 2011
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for ipilimumab from the RCSB Protein Data Bank (PDB 6RP8).
Interactive biological assembly from PDB entry 6RP8. 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 ipilimumab, in chronological order.
Reference approval
Approval date of the reference ipilimumab product.
15 yr 6 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 1 yr 3 mo
Frequently asked questions
Are there biosimilars approved for ipilimumab (Yervoy)?
No 351(k) biosimilars or interchangeable biosimilars referencing ipilimumab are listed in the FDA Purple Book yet.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
Explore the full FDA Purple Book
Search every FDA-licensed biologic, biosimilar, and interchangeable with exclusivity timelines and patent records.