Breo Ellipta - (100 mcg/25 mcg ; Powder for Inhalation)

Generic Name	Fluticasone furoate	Innovator	GlaxoSmithkline
Dosage	100 mcg/25 mcg ; Powder for Inhalation	Branded US Sales	More Than $1000 mn
Probable FTF	Less Than 5	Known Para IV Filers	Less Than 5
Other ANDA developers	None	Tentative Approvals	None
Final Approvals	None	Generic Launches	None
Indication	BREO ELLIPTA is a combination of fluticasone furoate, an inhaled corticosteroid (ICS), and vilanterol, a long-acting beta2-adrenergic agonist (LABA), indicated for: • Long-term, once-daily, maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). • Once-daily treatment of asthma in patients aged 18 years and older.
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