Purple Book reference family · 351(a) biologic
etanercept (Enbrel)
etanercept is an FDA-licensed reference biologic from Immunex Corporation, with 2 approved follow-on biologics.
351(a) biologicBLA 103795 Immunex Corporation
Biosimilars
2
Interchangeables
0
Listed patents
0
Reference approved
2007
Reference product
Originator biologic
351(a)BLA 103795
Enbrel etanercept
Also under this BLA: Enbrel MiniImmunex Corporation
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
20 yr 7 mo ago
Reference approval
Approval date of the reference etanercept product.
19 yr 11 mo ago
Biosimilars & interchangeables for etanercept
Follow-on biologics
| Product | Proper name | Applicant | Type | BLA | Approved |
|---|---|---|---|---|---|
| ErelziAlso under this BLA: Erelzi Sensoready | etanercept-szzs | Sandoz Inc. | Biosimilar 351(k) | 761042 | |
| Eticovo | etanercept-ykro | Samsung Bioepis Co., Ltd. | Biosimilar 351(k) | 761066 |
etanercept: 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 etanercept.
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.
