Viewing data from:

BREO ELLIPTA

NDA

FLUTICASONE FUROATE; VILANTEROL TRIFENATATE | N204275 | GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE

3 strengths4 unique patents5 unique exclusivities

Patent Timeline

4 unique patents, 2 exclusivities by expiration date

Expiring < 1yr (1)Active (3)TodayPED (+6 mo)Exclusivity

2027

2028

2029

2030

2031

Today

Dec. 14, 2027

Sep. 8, 2030

Apr. 11, 2031

Aug. 26, 2029

NPP

Nov. 13, 2026

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Urine Concentrations of Vilanterol After Inhaled Administration of Vilanterol/Fluticasone Furoate NCT03739294	Phase 2	Completed	Bispebjerg Hospital	26	2019-02-08 → 2020-12-14

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 7 NDCs (5 brand, 2 generic)

Highest NADAC/Unit

$6.50

per ea

Lowest NADAC/Unit

$3.86

per ea

Brand NDCs

Generic NDCs

Avg Brand: $6.04

Avg Generic: $3.87

36% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00173085910BREO ELLIPTA 100-25 MCG INHALR	$6.50	EA	Brand	$3.86	2026-08-19
00173088210BREO ELLIPTA 200-25 MCG INHALR	$6.50	EA	Brand	$3.88	2026-08-19
00173091610BREO ELLIPTA 50-25 MCG INHALER	$6.48	EA	Brand	—	2026-08-19
00173085914BREO ELLIPTA 100-25 MCG INHALR	$5.36	EA	Brand	—	2026-08-19
00173088214BREO ELLIPTA 200-25 MCG INHALR	$5.36	EA	Brand	—	2026-08-19
66993013697FLUTICASONE-VILANTEROL 200-25	$3.88	EA	Generic	—	2026-08-19
66993013597FLUTICASONE-VILANTEROL 100-25	$3.86	EA	Generic	—	2026-08-19

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 14 NDCs (7 FSS, 7 Big4)

Lowest Price

$63.27

Highest Price

$398.89

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
66993-0135-97FLUTICASONE 100MCG/VILANTEROL 25MCG INHL,ORAL	$161.96	Big4	Prasco, LLC	06/30/2026
66993-0135-97FLUTICASONE 100MCG/VILANTEROL 25MCG INHL,ORAL	$246.99	FSS	Prasco, LLC	06/30/2026
66993-0136-97FLUTICASONE 200MCG/VILANTEROL 25MCG INHL,ORAL	$162.22	Big4	Prasco, LLC	06/30/2026
66993-0136-97FLUTICASONE 200MCG/VILANTEROL 25MCG INHL,ORAL	$246.99	FSS	Prasco, LLC	06/30/2026
00173-0859-10BREO ELLIPTA INHALER 100/25MCG	$297.31	Big4	GlaxoSmithKline	07/31/2027
00173-0859-10BREO ELLIPTA INHALER 100/25MCG	$382.81	FSS	GlaxoSmithKline	07/31/2027

Showing 6 of 14 NDCs.

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Breo Ellipta (2024)

Total Spending

$1.4B

Total Claims

2,617,269

Beneficiaries

596,052

Avg Cost/Unit

$6.50

Spending Trend

$1.3B(2019)→$1.5B(2020)→$1.5B(2021)→$1.4B(2022)→$1.4B(2023)→$1.4B(2024)

YoY Change:-6.3%

5yr CAGR:+1.5%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
May 15, 2023	SUPPL -22	View Letter (PDF)
Feb 13, 2019	SUPPL -17	View Letter (PDF)
Dec 27, 2017	SUPPL -15	View Letter (PDF)
May 17, 2017	SUPPL -12	View Letter (PDF)
Nov 2, 2016	SUPPL -11	View Letter (PDF)
Feb 18, 2016	SUPPL -9	View Letter (PDF)
Sep 16, 2015	SUPPL -4	View Letter (PDF)
May 4, 2015	SUPPL -1	View Letter (PDF)
Mar 3, 2015	SUPPL -2	View Letter (PDF)
May 13, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 0.1MG/INH;EQ 0.025MG BASE/INH

RLD

4 patents3 exclusivities▴

POWDER;INHALATION | Approved: May 10, 2013

Patents (4) · 6 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8511304	Jun 14, 2027PED: Dec 14, 2027	PED	—	Yes		—
8534281	Mar 8, 2030PED: Sep 8, 2030	PED	—	Yes	—	—
8746242	Oct 11, 2030PED: Apr 11, 2031	PED	—	Yes	—	—
11116721	Feb 26, 2029PED: Aug 26, 2029	PED	—	Yes		—

Exclusivities (3)

Code	Date	Status
NPP	May 13, 2026	Expired
PED	Nov 13, 2026	< 1 year
NPP*PEDNewly listed — daily FDA feed, not yet in monthly Orange Book edition	Nov 13, 2026	< 1 year

#002 — 0.2MG/INH;EQ 0.025MG BASE/INH

RLD

4 patents0 exclusivities▾

POWDER;INHALATION | Approved: Apr 30, 2015

#003 — 0.05MG/INH;EQ 0.025MG BASE/INH

RLD

4 patents3 exclusivities▾

POWDER;INHALATION | Approved: May 12, 2023

Change History (2)

Recent changes detected for this application.

ADDED8/25/2026

Breo Ellipta (fluticasone furoate; vilanterol trifenatate) gained pediatric exclusivity expiring Nov 2026, extending its regulatory protection period.

New: BREO ELLIPTA (FLUTICASONE FUROATE; VILANTEROL TRIFENATATE) — exclusivity NPP*PED exp 11/13/2026

ADDED8/25/2026

BREO ELLIPTA (fluticasone furoate/vilanterol trifenatate) received pediatric exclusivity designation expiring Nov 2026, extending its regulatory protection beyond the original approval date.

New: BREO ELLIPTA (FLUTICASONE FUROATE; VILANTEROL TRIFENATATE) — exclusivity NS*PED exp 11/13/2026