Purple Book reference family · 351(a) biologic
evinacumab-dgnb (Evkeeza)
evinacumab-dgnb is an FDA-licensed reference biologic from Regeneron Pharmaceuticals, Inc..
351(a) biologicBLA 761181 Regeneron Pharmaceuticals, Inc.
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2021
Reference product
Originator biologic
351(a)BLA 761181
Evkeeza evinacumab-dgnb
Regeneron Pharmaceuticals, 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 evinacumab-dgnb product.
5 yr 8 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 3 yr 7 mo
evinacumab-dgnb: 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 evinacumab-dgnb.
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