Hemlibra® (emicizumab-kxwh)

BL 761083

Hemlibra® (emicizumab-kxwh)

BL 761083

U.S. License Holder:

Genentech

Date of License:

November-16-2017

Last Update:

Nov-15-2024

approved_indications FDA-Approved Indications

HEMLIBRA (emicizumab) is a bispecific factor IXa- and factor X-directed antibody indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients age newborn and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.

approved_indications U.S. Patent Litigations

PACER

Case No(s):

1:17-cv-00509 (D. Del.)

U.S. Patent Nos.
7,033,590 (Factor IX/Factor IXa Activating Antibodies and Antibody Derivatives)

Plaintiffs
Baxalta GmbH; Baxalta Incorporated

Defendants
Chugai Pharmaceutical Co., Ltd.; Genentech, Inc.

Federal Circuit Appeal(s)
19-1527; 22-1461

Status
Final Judgment of Non-Infringement, Counter-claims Dismissed; Federal Circuit Vacated and Remanded, Summary Judgment of Invalidity for Lack of Enablement on Remand; Federal Circuit Appeal of Remand Decision Affirmed

BPCIA
N

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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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