Purple Book product · Reference 351(a)

Nexobrid

anacaulase-bcdb

351(a)BLA 761192DiscLicensed Vericel Corporation

View anacaulase-bcdb family Label PDF Open on FDA Purple Book

Dec 28, 2022

Approved

Reference 351(a)

License type

Disc

Marketing

None

Listed patents

Nexobrid (anacaulase-bcdb) is Vericel Corporation's FDA-licensed reference biologic, approved under a 351(a) BLA in 2022. No biosimilars referencing Nexobrid are listed in the Purple Book yet.

Sourced from the FDA Purple Book · verified Jul 02, 2026

Key dates

Approval
Approval date of this BLA submission.
Dec 28, 2022
3 yr 7 mo ago
Today
Orphan exclusivity ends
7-year orphan-drug exclusivity window.
Aug 15, 2031
in 5 yr 2 mo

Pharmaceutical detail

Strength

8.8% (1.94GM)

Dosage form

For Topical Gel

Route

Topical

Presentation

Single-Use Jar

Center

CDER

License number

2010

Product number

001

Submission type

Original

Supplement number

Not listed

Change type

Not listed

Reference product family

View full family

This is the reference (originator) product. No biosimilars or interchangeables reference it in the Purple Book yet.

1 additional BLA record for this product (other strengths or presentations) are in the same reference family.

Patent list

No patent-list records were published for this product. The Purple Book patent list reflects the statutory patent exchange under the BPCIA and is not exhaustive.

Source provenance

Source kind · Advanced Search

Checked Jul 02, 2026

FDA source FDA source

advanced-searchAdvanced Search · Jul 02, 2026
monthly-downloadMonthly download · Jul 02, 2026

Change history

v4Jul 02, 2026
v3Jul 02, 2026
v2Jul 02, 2026

Frequently asked questions

Does Nexobrid have approved biosimilars?

No 351(k) biosimilars or interchangeable biosimilars referencing Nexobrid are listed in the FDA Purple Book yet.

What is Nexobrid's BLA number?

Nexobrid is licensed under BLA 761192, held by Vericel Corporation.

When was Nexobrid approved by the FDA?

Nexobrid was approved by the FDA on Dec 28, 2022.

Related FDA reference tools

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo