Stelara® (ustekinumab)

BL 125261 [BL 761044]

Stelara® (ustekinumab)

BL 125261 [BL 761044]

U.S. License Holder:

Centocor Ortho Biotech Inc. (Janssen Biotech, Inc.)

Date of License:

September-25-2009 [September-23-2016]

Last Update:


approved_indications FDA-Approved Indications

STELARA (ustekinumab) is a human interleukin-12 and -23 antagonist indicated for the treatment of:

Adult patients with:

Moderate to severe plaque psoriasis (Ps) who are candidates for phototherapy or systemic therapy;

Active psoriatic arthritis (PsA);

Moderately to severely active Crohn's disease (CD);

Moderately to severely active ulcerative colitis;

Pediatric patients 6 years and older with:

Moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy;

Active psoriatic arthritis (PsA).

approved_indications aBLA / 505(b)(2) Activity

aBLA / 505(b)(2) Accepted by FDA

ABP 654: Amgen (November-2022) AVT04: Alvotech / Teva (January-2023)

approved_indications U.S. Patent Litigations


Case No(s):

U.S. Patent Nos.
6,902,734 (Anti-IL-12 Antibodies and Compositions Thereof) 10,961,307 (Methods of Treating Moderately to Severely Active Ulcerative Colitis by Administering an Anti-IL12/IL23 Antibody)

Janssen Biotech, Inc.

Amgen, Inc.



U.S. Patent Nos.
6,914,128 (Human Antibodies that Bind Human IL-12 and Methods for Producing) 7,504,485 (Human Antibodies that Bind Human IL-12)

Abbott Bioresearch Center, Inc.; Abbott Biotechnology Ltd; Abbott GmbH and Co. KG; AbbVie Deutschland GmbH and Co. KG; AbbVie Bioresearch Center, Inc.

Centocor Biologics LLC; Centocor Ortho Biotech, Inc. Janssen Biotech, Inc.

Federal Circuit Appeal(s)
13-1338 13-1346

Jury Verdict (Claims Invalid); Federal Circuit Affirmed



Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website ( 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 ( 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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