NDAINHALATIONPOWDER
Approved
May 2013
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
1
Mechanism of Action
vilanterol. The mechanisms of action described below for the individual components apply to BREO ELLIPTA. These drugs represent 2 different classes of medications (an ICS and a LABA), each having different effects on clinical and physiological indices. Fluticasone Furoate Fluticasone furoate is a…
Indications (3)
Clinical Trials (1)
Study to Evaluate the Therapeutic Equivalence and Safety of Fluticasone Furoate and Vilanterol Inhalation Powder 100 mcg/25 mcg and BREO ELLIPTA 100 mcg/25 mcg in Participants With Asthma
Started Apr 2026
1,430 enrolled
Respiratory
Loss of Exclusivity
LOE Date
Apr 11, 2031
62 months away
Patent Expiry
Apr 11, 2031
Exclusivity Expiry
Nov 13, 2026
Patent Records (5)
| Patent # | Expiry | Type | Use Code |
|---|---|---|---|
| 8511304 | Jun 14, 2027 | Product | U-3623 |
| 8511304*PED | Dec 14, 2027 | — | |
| 11116721 | Feb 26, 2029 | Product | U-1691 |
| 11116721*PED | Aug 26, 2029 | — | |
| 8534281 | Mar 8, 2030 | Product | — |