Dysport® (abobotulinumtoxinA)

BL 125274

Dysport® (abobotulinumtoxinA)

BL 125274

U.S. License Holder:

Ipsen Biopharm Ltd.

Date of License:

April-29-2009

Last Update:

September-23-2022

approved_indications FDA-Approved Indications

DYSPORT (abobotulinumtoxinA) is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for:

The treatment of cervical dystonia in adults;

The temporary improvement in the appearance of moderate to severe glabellar lines associated with procerus and corrugator muscle activity in adult patients greater than 65 years of age;

The treatment of upper and lower limb spasticity in adults;

The treatment of upper limb spasticity in pediatric patients 2 years of age and older, excluding spasticity caused by cerebral palsy;

The treatment of lower limb spasticity in pediatric patients 2 years of age and older.

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

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)

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

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

Federal Circuit Appeal(s)
22-1165

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

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Methodology

Information contained in the Venable Fitzpatrick 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 Fitzpatrick BiologicsHQ database.

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