Orencia® (abatacept)

BL 125118

Orencia® (abatacept)

BL 125118

U.S. License Holder:

Bristol-Myers Squibb

Date of License:

December-23-2005

Last Update:

Dec-15-2024

approved_indications FDA-Approved Indications

ORENCIA (abatacept) is a selective T cell costimulation modulator indicated for:

The treatment of adult patients with moderately to severely active rheumatoid arthritis (RA);

The treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA);

The treatment of patients 2 years of age and older with active psoriatic arthritis (PsA);

The prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor.

approved_indications Inter Partes Review Proceedings

PTAB Portal

IPR Case No(s):

IPR2015-01537

U.S. Patent No.
8,476,239 (Stable Protein Formulations)

Patent Owner
Bristol-Myers Squibb Co.

Petitioner(s)
Momenta Pharmaceuticals, Inc.; Mylan GmbH; Mylan Inc.; Mylan Institutional LLC; Mylan Ireland Ltd.; Mylan NV; Mylan Pharmaceuticals Inc.

§ 102 Challenge
N

§ 103 challenge
Y: Claims 1-15

Claim Types Challenged Under § 103
Formulation Other (Article of Manufacture)

§ 103 Challenge Instituted
Y

Final Written Decision Issued
Y

Federal Circuit Appeal(s)
17-1694

IPR Status
Final Written Decision (No Instituted Claim Found Unpatentable); Appeal to Federal Circuit Dismissed for Lack of Standing/Jurisdiction and Mootness

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Methodology

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