Daxxify (daxibotulinumtoixnA-lanm)

BL 761127

Daxxify (daxibotulinumtoixnA-lanm)

BL 761127

U.S. License Holder:

Revance Therapeutics, Inc.

Date of License:

September-07-2022

Last Update:

Nov-23-2023

approved_indications FDA-Approved Indications

DAXXIFY (daxibotulinumtoixnA-lanm) is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for:

Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients;

The treatment of cervical dystonia in adult patients.

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2021-01203

U.S. Patent No.
9,480,731 (Long Lasting Effect of New Botulinum Toxin Formulations)

Patent Owner
Medy-Tox Inc.; AbbVie Inc.; Allergan, Inc.; Allergan Pharmaceuticals Holding (Ireland); Allergan Pharmaceuticals Ireland

Petitioner(s)
Revance Therapeutics, Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1, 2, 5-10, 13-14

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted; Request for Rehearing Denied

IPR2021-01204

U.S. Patent No.
9,480,731 (Long Lasting Effect of New Botulinum Toxin Formulations)

Patent Owner
Medy-Tox Inc.; AbbVie Inc.; Allergan, Inc.; Allergan Pharmaceuticals Holding (Ireland); Allergan Pharmaceuticals Ireland

Petitioner(s)
Revance Therapeutics, Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 3-4, 11-12

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted; Request for Rehearing Denied

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:21-cv-01411 (D. Del.)

U.S. Patent Nos.
7,332,567 (Fret Protease Assays for Clostridial Toxins) 7,354,740 (Animal Product Free System and Process for Purifying a Botulinum Toxin) 8,409,828 (Animal Product Free System and Process for Purifying a Botulinum Toxin) 11,033,625 (Method for Stabilizing a Toxin) 11,124,786 (Process and System for Obtaining Botulinum Neurotoxin) 11,147,878 (Animal Protein-Free Pharmaceutical Compositions) 11,203,748 (Process and System for Obtaining Botulinum Neurotoxin) 11,285,216 (Animal Protein-Free Pharmaceutical Compositions) 11,326,155 (Process and System for Obtaining Botulinum Neurotoxin)

Plaintiffs
Allergan Inc.; Allergan Pharmaceuticals Ireleand

Defendants
Revance Therapeuticls, Inc.; Ajinomoto Althea, Inc.

Status
Case Ongoing; Stipulated Dismissal of 7,332,567 Patent

BPCIA
N

Related News

Venable’s BiologicsHQ Monthly Injection – September 2022
April Breyer Menon Damineh Morsali, Ph.D. Robert S. Schwartz, Ph.D.
October 11, 2022

Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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