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NEXOBRID

BLA

ANACAULASE-BCDB | B761192 | MEDIWOUND, LTD

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

December 28, 2034(3100 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Dec. 28, 2034	Active	Computed
7-Year Orphan	Aug. 15, 1931	Expired	Purple Book

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Feb. 16, 20322054 days remaining

Based on latest discovered patent 8119124(composition) · relevance 95/100

Estimate based on AI-discovered patents. No patents are officially listed in the Purple Book for this product.

Discovered Patents

View all 2 patents →

2 AI-discovered patents, sorted by relevance.

Composition

(1)

95/1008119124Grant: 2012-02-21 | Exp: 2032-02-16

Device

(1)

65/1007128719Grant: 2006-10-31 | Exp: 2026-10-26

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Purple Book (Biologics)

BLA 761192 | 2 presentations

351(a) ReferenceLicensedCDERFor Topical Gel

Proper Name

anacaulase-bcdb

Applicant

Vericel Corporation

Approval Date

28-Dec-22

Orphan Exclusivity

15-Aug-31

Expired

Presentations

8.8% (1.94GM) — Single-Use Jar (Topical)

8.8% (4.85GM) — Single-Use Jar (Topical)

Source: FDA Purple Book (purplebooksearch.fda.gov).

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Aug 16, 2024	SUPPL -10	View Letter (PDF)
Feb 3, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 8.8%

▴

GEL;TOPICAL | Approved: 2022-12-28 00:00:00

No patent or exclusivity listings for this strength.