Xolair - (150MG/Vial, 75MG/0.5ml, 150MG/ml, 300MG/2ml ; Vial, Syringe)

Generic Name	Omalizumab	Innovator	Genentech, Inc.
Dosage	150MG/Vial, 75MG/0.5ml, 150MG/ml, 300MG/2ml ; Vial, Syringe	Branded US Sales	More Than $1000 mn
Probable FTF	None	Known Para IV Filers	Less Than 5
Other ANDA developers	None	Tentative Approvals	None
Final Approvals	None	Generic Launches	None
Indication	XOLAIR is an anti-IgE antibody indicated for: • Moderate to severe persistent asthma in adults and pediatric 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 • Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment • IgE-mediated food allergy in adult and pediatric patients aged 1 year and older for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjunction with food allergen avoidance • Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment
Complexities	Yes

Executive Summary

Patent Status

Launch Timelines and Competition

Company	FTF Status / 180 days exclusivity	30-Months stay	Current Litigation Status	Current Approval Status	Likelihood of launch
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Chronology Of Events