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BLA

DAXIBOTULINUMTOXINA-LANM | B761127 | REVANCE THERAPEUTICS, INC.

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

September 7, 2034(2988 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Sep. 7, 2034	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

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 761127 | 2 presentations

351(a) ReferenceLicensedCDERFor Injection

Proper Name

daxibotulinumtoxinA-lanm

Applicant

Revance Therapeutics, Inc.

Approval Date

7-Sep-22

50UNITS — Single-Dose Vial (Intramuscular)

100UNITS — Single-Dose Vial (Intramuscular)

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Aug 14, 2023	SUPPL -2	View Letter (PDF)
Sep 8, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.1ML

▴

INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | Approved: 2022-09-07 00:00:00

No patent or exclusivity listings for this strength.