Botox® (onabotulinumtoxinA)

BL 103000

Botox® (onabotulinumtoxinA)

BL 103000

U.S. License Holder:

Allergan

Date of License:

December-09-1991

Last Update:

Sep-30-2024

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.

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

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)

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)

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

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

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

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):

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

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

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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