U.S. License Holder:
Bristol Myers Squibb
Date of License:
ORENCIA (abatacept) is a selective T cell costimulation modulator indicated for:
Adult Rheumatoid Arthritis (RA): moderately to severely active RA in adults. ORENCIA may be used as monotherapy or concomitantly with DMARDs other than TNF antagonists;
Juvenile Idiopathic Arthritis: moderately to severely active polyarticular juvenile idiopathic arthritis in pediatric patients 2 years of age and older. ORENCIA may be used as monotherapy or concomitantly with methotrexate;
Adult Psoriatic Arthritis (PsA): active PsA in adults.
aBLA / 505(b)(2) Activity
aBLA / 505(b)(2) Approved by FDA
Inter Partes Review ProceedingsPTAB Portal
IPR Case No(s):
U.S. Patent No.
8,476,239 (Stable Protein Formulations)
Bristol Myers Squibb Co.
Momenta Pharmaceuticals, Inc.; Mylan GmbH; Mylan Inc.; Mylan Institutional LLC; Mylan Ireland Ltd.; Mylan NV; Mylan Pharmaceuticals Inc.
§ 102 Challenge
§ 103 challenge
Claim Types Challenged Under § 103
Formulation Other (Article of Manufacture)
§ 103 Challenge Instituted
Final Written Decision Issued
Federal Circuit Appeal(s)
Final Written Decision (No Instituted Claim Found Unpatentable); Appeal to Federal Circuit Dismissed for Lack of Standing/Jurisdiction and Mootness