Purple Book reference family · 351(a) biologic
epcoritamab-bysp (Epkinly)
epcoritamab-bysp is an FDA-licensed reference biologic from Genmab US, Inc..
351(a) biologicBLA 761324 Genmab US, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2023
Reference product
Originator biologic
351(a)BLA 761324
Epkinly epcoritamab-bysp
Genmab US, Inc.
View full reference-product record- Approved
- Marketing
- Rx
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference epcoritamab-bysp product.
3 yr 5 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 4 yr 10 mo
epcoritamab-bysp: 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 epcoritamab-bysp.
Related FDA reference tools
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- 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.
