Dysport® (abobotulinumtoxinA)

BL 125274

Dysport® (abobotulinumtoxinA)

BL 125274

U.S. License Holder:

Ipsen Biopharm Ltd.

Date of License:

April-29-2009

Last Update:

December-09-2018

approved_indications FDA-Approved Indications


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

The treatment of adults with cervical dystonia;

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

The treatment of spasticity in adults;

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):

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)

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.

Disclaimer

The individuals who maintain this site work for Venable LLP. The information, comments and links posted on this site do not constitute legal advice. No attorney-client relationship has been or will be formed by any communication(s) to, from or with the site and/or the author. For legal advice, contact an attorney at Venable LLP or an attorney actively practicing in your jurisdiction. Do not send any confidential or privileged information to the author; neither Venable LLP nor the author will assume any liability or responsibility for it. If you send any information, documents or materials to the site, you give permission for the author to include them on or in the site. No information, documents or materials you send to the site will be considered confidential or privileged by Venable LLP or its lawyers. Also, no such information, documents or materials will be returned to you. All decisions relating to the content belong to the author.

Subscribe for Future Updates

captcha