Purple Book reference family · 351(a) biologic
anacaulase-bcdb (Nexobrid)
anacaulase-bcdb is an FDA-licensed reference biologic from Vericel Corporation.
351(a) biologicBLA 761192 Vericel Corporation
Biosimilars
0
Interchangeables
0
Listed patents
0
Reference approved
2022
Reference product
Originator biologic
351(a)BLA 761192
Nexobrid anacaulase-bcdb
Vericel Corporation
View full reference-product record- Approved
- Marketing
- Disc
- Center
- CDER
- Patents
- None listed
Exclusivity & patent cliffs
Protection horizon
Reference approval
Approval date of the reference anacaulase-bcdb product.
3 yr 9 mo ago
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
in 5 yr
anacaulase-bcdb: 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 anacaulase-bcdb.
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- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
