Skyrizi® (risankizumab-rzaa)

BL 761105 [BL 761262]

Skyrizi® (risankizumab-rzaa)

BL 761105 [BL 761262]

U.S. License Holder:

AbbVie Inc.

Date of License:

April-23-2019

Last Update:

Nov-15-2024

approved_indications FDA-Approved Indications

SKYRIZI (risankizumab-rzaa) is an interleukin-23 antagonist indicated for the treatment of:

Moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy;

Active psoriatic arthritis in adults;

Moderately to severely active Crohn's disease in adults;

Moderately to severely active ulcerative colitis in adults.

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

PGR2022-00037

U.S. Patent No.
11,078,265 (Anti-IL-23 Antibodies)

Patent Owner
Boehringer Ingelheim International GmbH

Petitioner(s)
Sandoz, Inc.; Sandoz AG

§ 102 Challenge
N

§ 103 challenge
N

IPR Status
Challenges Include Written Description (Claims 7-10, 14-16, 19-22, 27-28) and Enablement (Claims 7-10, 14-16, 19-22, 27-28). Institution Denied, Request for Rehearing Denied

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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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