Botox® (onabotulinumtoxinA)

BL 103000

Botox® (onabotulinumtoxinA)

BL 103000

U.S. License Holder:

Allergan

Date of License:

December-09-1991

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

BOTOX (onabotulinumtoxinA) is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for:

Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication;

Treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition [e.g., spinal cord injury (SCI), multiple sclerosis (MS)] in adults who have an inadequate response to or are intolerant of an anticholinergic medication;

Treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 5 years of age and older who have an inadequate response to or are intolerant of anticholinergic medication;

Prophylaxis of headaches in adult patients with chronic migraine (15 days or more per month with headache lasting 4 hours a day or longer);

Treatment of spasticity in patients 2 years of age and older;

Treatment of cervical dystonia in adult patients, to reduce the severity of abnormal head position and neck pain;

Treatment of severe axillary hyperhidrosis that is inadequately managed by topical agents in adult patients;

Treatment of blepharospasm associated with dystonia in patients 12 years of age or older;

Treatment of strabismus in patients 12 years of age or older.

BOTOX COSMETIC is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated in adult patients for the temporary improvement in the appearance of:

Moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity;

Moderate to severe lateral canthal lines associated with orbicularis oculi activity;

Moderate to severe forehead lines associated with frontalis muscle activity;

Moderate to severe platysma bands associated with platysma muscle activity.

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2015-01119

U.S. Patent No.
7,148,041 (Animal Product Free Media and Processes for Obtaining a Botulinum Toxin)

Patent Owner
Allergan, Inc.

Petitioner(s)
Galderma S.A.; Galderma Labs, LP; Galderma Labs, Inc.; Galderma R&D, SNC; Nestle Skin Health, Inc.

§ 102 Challenge
Y: Claims 1, 3-6

Claim Types Challenged Under § 102
Manufacturing

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1-11

Claim Types Challenged Under § 103
Manufacturing

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

IPR Status
Final Written Decision (Adverse Judgment in Favor of Petitioner for Patent Owner Failure to Respond)

IPR2016-00102

U.S. Patent No.
6,806,251 (Method of Treating Pain)

Patent Owner
1474791 Ontario, Ltd.

Petitioner(s)
Allergan, Inc.; Allergan Sales, LLC; Allergan plc f/k/a Actavis plc

§ 102 Challenge
Y: Claims 1-7

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y (in part): Claims 1-4, 6, 7

§ 103 challenge
Y: Claims 1-7

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

IPR Status
Final Written Decision (All Instituted Claims Found Unpatentable)

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

IPR2023-00604

U.S. Patent No.
11,331,598 (Method of Isolating Botulinum Toxin from Botulinum Toxin-Containing Solution)

Patent Owner
Medy-Tox Inc.

Petitioner(s)
Hugel, Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-9

Claim Types Challenged Under § 103
Manufacturing

§ 103 Challenge Instituted
N

IPR Status
IPR Not Instituted

PGR2019-00062

U.S. Patent No.
10,143,728 (Long Lasting Effect of New Botulinum Toxin Formulations)

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

Petitioner(s)
Galderma S.A.; Galderma Labs, LP; Galderma Labs, Inc.; Galderma R&D, SNC; Galderma Skin Health SA; Nestle SA; SHDS, Inc.

§ 102 Challenge
Y: Claims 1-3, 8

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y: Claims 1-8, 10

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
22-1165

IPR Status
Challenges Also Include Enablement (Claims 1-10), Written Description (Claims 1-10), and Indefiniteness (Claims 1-10). FWD (Non-Contingent MTA Denied); Request for Director Review or Panel Rehearing Denied; Federal Circuit Appeal: USPTO Director Intervened, Decision Affirmed

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:15-cv-03372 (N.D. Ill.)

U.S. Patent Nos.
6,806,251 (Method of Treating Pain)

Plaintiffs
1474971 Ontario Ltd.

Defendants
Allergan Sales, LLC; Allergan Inc.

Status
Dismissed

BPCIA
N

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

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