Xolair® (omalizumab)

BL 103976

Xolair® (omalizumab)

BL 103976

U.S. License Holder:

Genentech

Date of License:

June-20-2003

Last Update:

March-23-2023

approved_indications FDA-Approved Indications

XOLAIR (omalizumab) is an anti-IgE antibody indicated for:

Moderate to severe persistent asthma in patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids;

Nasal polyps in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment;

Chronic idiopathic urticaria in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment.

approved_indications U.S. Patent Litigations

PACER

Case No(s):

3:08-cv-04909 (N.D. Cal.)

U.S. Patent Nos.
5,849,522 (Enhancer for Eukaryotic Expression Systems) 6,218,140 (Enhancer for Eukaryotic Expression Systems)

Plaintiffs
Sanofi-Aventis Deutschland GmbH; Sanofi-Aventis U.S. LLC; Sanofi-Aventis U.S. Inc.

Defendants
Biogen IDEC, Inc.; Genentech, Inc.

Federal Circuit Appeal(s)
12-1454

Status
Case Terminated

BPCIA
N

3:09-cv-04919 (N.D. Cal.)

U.S. Patent Nos.
5,849,522 (Enhancer for Eukaryotic Expression Systems) 6,218,140 (Enhancer for Eukaryotic Expression Systems)

Plaintiffs
Sanofi-Aventis Deutschland GmbH

Defendants
Biogen IDEC, Inc.; Genentech, Inc.

Federal Circuit Appeal(s)
12-1454

Status
Case Terminated

BPCIA
N

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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