Yesintek (ustekinumab-kfce)

aBL 761406

Yesintek (ustekinumab-kfce)

aBL 761406

U.S. License Holder:

Biocon Biologics

Date of License:

November-29-2024

Last Update:

Jan-23-2025

approved_indications FDA-Approved Indications

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

Adult patients with:

Moderate to severe plaque psoriasis (PsO) 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 Approved Foreign Follow-On Biologics / Biosimilars

Biosimilars Approved In Japan

Ustekinumab BS (Biocon) (January-2025)

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2023-01444

U.S. Patent No.
10,961,307 (Methods of Treating Moderately to Severely Active Ulcerative Colitis by Administering an Anti-IL12/IL23 Antibody)

Patent Owner
Janssen Biotech, Inc.

Petitioner(s)
Biocon Biologics Inc.; Biocon Biologics Limited; Biocon Biologics UK Limited; Biocon Limited

§ 102 Challenge
Y: Claims 1-4, 6-22, 24-34

Claim Types Challenged Under § 102
Method of Treatment

§ 102 Challenge Instituted
Terminated Prior to Institution Decision

§ 103 challenge
Y: Claims 1-34

Claim Types Challenged Under § 103
Method of Treatment

§ 103 Challenge Instituted
Terminated Prior to Institution Decision

Settled / Challenged Claims Disclaimed / Challenge Terminated
Y (Settled Prior to Institution Decision)

IPR Status
Settled Prior to Institution Decision

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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