infliximab (Remicade)
infliximab is an FDA-licensed reference biologic from Janssen Biotech, Inc., with 4 approved follow-on biologics.
Reference product
Remicade infliximab
Janssen Biotech, Inc.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Molecular structure
Experimental 3D structure for infliximab from the RCSB Protein Data Bank (PDB 5VH3).
Interactive biological assembly from PDB entry 5VH3. Drag to rotate, scroll to zoom, and inspect the full atomic structure right here, with no need to leave the page.
Exclusivity & patent cliffs
Reference approval
Approval date of the reference infliximab product.
28 yr 6 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
8 yr 1 mo ago
Biosimilars & interchangeables for infliximab
| Product | Proper name | Applicant | Type | BLA | Approved |
|---|---|---|---|---|---|
| Inflectra | infliximab-dyyb | CELLTRION, Inc. | Biosimilar 351(k) | 125544 | |
| Renflexis | infliximab-abda | Samsung Bioepis Co., Ltd. | Biosimilar 351(k) | 761054 | |
| Ixifi | infliximab-qbtx | Pfizer Ireland Pharmaceuticals Unlimited Company | Biosimilar 351(k) | 761072 | |
| Avsola | infliximab-axxq | Amgen Inc. | Biosimilar 351(k) | 761086 |
infliximab: 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 infliximab.
Related FDA reference tools
- FDA Orange BookApproved drugs, generics, therapeutic-equivalence codes, patents, and exclusivity.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
