Botox® (onabotulinumtoxinA)

BL 103000

Botox® (onabotulinumtoxinA)

BL 103000

U.S. License Holder:

Allergan

Date of License:

December-09-1991

Last Update:

December-09-2018

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;

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 adult patients;

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

Claim Types Challenged Under § 102
Manufacturing

§ 102 Challenge Instituted
Y

§ 103 challenge
Y

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

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Y

§ 103 challenge
Y

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)

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

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Venable Fitzpatrick’s BiologicsHQ Monthly Injection – July 2017 April M. Breyer Menon; Corinne E. Atton; Robert S. Schwartz, Ph.D. July 26, 2017

Methodology

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