Orencia® (abatacept)

BL 125118

Orencia® (abatacept)

BL 125118

U.S. License Holder:

Bristol-Myers Squibb

Date of License:

December-23-2005

Last Update:

Sep-30-2024

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):

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

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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