Viewing data from:

ADVAIR HFA

NDA

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE | N021254 | GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE

3 strengths0 unique patents0 unique exclusivities

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

88 trials from ClinicalTrials.gov, 81 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable Tablets NCT00328718	Phase 3	Completed	GlaxoSmithKline	526	2005-10 → 2007-04
A Study to Assess the Efficacy of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)NCT01706328	Phase 3	Completed	GlaxoSmithKline	828	2012-10-15 → 2013-06-17
Evaluating the Control of COPD Symptoms in Patients Treated With Tiotropium Bromide 18mcg Once Daily Alone, ADOAIR 50/250mcg Twice Daily Alone or ADOAIR 50/250mcg Plus Tiotropium Bromide 18mcg NCT01762800	Phase 4	Completed	GlaxoSmithKline	407	2013-02 → 2015-09
Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler NCT02980133	Phase 3	Completed	Teva Branded Pharmaceutical Products R&D, Inc.	841	2016-12-28 → 2019-04-13
Study Of Asthma In Patients Of African Descent NCT00102765	Phase 4	Completed	GlaxoSmithKline	479	2004-11 → 2007-04
Advair® DISKUS® Versus Serevent® DISKUS® For Chronic Obstructive Pulmonary Disease Exacerbations NCT00115492	Phase 4	Completed	GlaxoSmithKline	797	2004-12 → 2007-06
Study In Airway Physiology In Children SERETIDE DISKUS ® Inhlaer and FLIXOTIDE® Inhaler Are Trademarks of GSK Group of Companies.NCT00169546	Phase 4	Completed	GlaxoSmithKline	64	2003-01 → 2005-12
Survival Of Subjects With Chronic Obstructive Pulmonary Disease (COPD)NCT00268216	Phase 3	Completed	GlaxoSmithKline	6,228	2000-09 → 2005-11
Study Of Allergic Rhinitis In Patients Who Also Have Asthma NCT00296491	Phase 4	Completed	GlaxoSmithKline	725	2005-09 → 2007-10
Study of Inhaled Glucocorticosteroids/Long-Acting Bronchodilator Drugs in Subjects With Asthma That Have Been Taking Inhaled Glucocorticosteroids (Study P04705AM1)NCT00424008	Phase 3	Completed	Organon and Co	722	2007-04 → 2008-11

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 9 NDCs (6 brand, 3 generic)

Highest NADAC/Unit

$35.03

per gm

Lowest NADAC/Unit

$16.79

per gm

Brand NDCs

Generic NDCs

Avg Brand: $24.98

Avg Generic: $21.63

13% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00173071720ADVAIR HFA 230-21 MCG INHALER	$35.03	GM	Brand	$27.44	2026-06-17
00173071722ADVAIR HFA 230-21 MCG INHALER	$30.64	GM	Brand	—	2026-06-17
66993008896FLUTICASONE-SALMETEROL 230-21	$27.44	GM	Generic	—	2026-06-17
00173071620ADVAIR HFA 115-21 MCG INHALER	$25.41	GM	Brand	$20.65	2026-06-17
66993008796FLUTICASONE-SALMETEROL 115-21	$20.65	GM	Generic	—	2026-06-17
00173071522ADVAIR HFA 45-21 MCG INHALER	$20.07	GM	Brand	—	2026-06-17

Showing 6 of 9 NDCs.

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

VA Federal Supply Schedule

Government-negotiated contract prices | 18 NDCs (9 FSS, 9 Big4)

Lowest Price

$107.19

Highest Price

$433.10

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00173-0716-20ADVAIR HFA 115MCG/21MCG INHL AEROSOL	$314.11	FSS	GlaxoSmithKline	07/31/2027
00173-0716-20ADVAIR HFA 115MCG/21MCG INHL AEROSOL	$228.31	Big4	GlaxoSmithKline	07/31/2027
00173-0716-22ADVAIR HFA 115MCG/21MCG INHL AEROSOL	$154.11	FSS	GlaxoSmithKline	07/31/2027
00173-0716-22ADVAIR HFA 115MCG/21MCG INHL AEROSOL	$107.19	Big4	GlaxoSmithKline	07/31/2027
00173-0717-20ADVAIR HFA 230MCG/21MCG INHL AEROSOL	$433.10	FSS	GlaxoSmithKline	07/31/2027
00173-0717-20ADVAIR HFA 230MCG/21MCG INHL AEROSOL	$306.08	Big4	GlaxoSmithKline	07/31/2027

Showing 6 of 18 NDCs.

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

Medicare Part D Spending

CMS annual spending data for Advair HFA (2024)

Total Spending

$320.6M

Total Claims

715,505

Beneficiaries

200,081

Avg Cost/Unit

$28.71

Spending Trend

$276.7M(2019)→$313.8M(2020)→$346.3M(2021)→$384.7M(2022)→$398.4M(2023)→$320.6M(2024)

YoY Change:-26.5%

5yr CAGR:-6.1%

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

Approval Letters

16 letters from Drugs@FDA

Date	Submission	Document
Aug 19, 2021	SUPPL -36	View Letter (PDF)
Feb 13, 2019	SUPPL -28	View Letter (PDF)
Dec 27, 2017	SUPPL -27	View Letter (PDF)
Mar 3, 2017	SUPPL -26	View Letter (PDF)
Dec 12, 2014	SUPPL -24	View Letter (PDF)
Nov 14, 2014	SUPPL -23	View Letter (PDF)
Dec 21, 2012	SUPPL -9	View Letter (PDF)
Aug 13, 2012	SUPPL -19	View Letter (PDF)
Jul 5, 2011	SUPPL -16	View Letter (PDF)
May 12, 2011	SUPPL -15	View Letter (PDF)
Jan 7, 2011	SUPPL -12	View Letter (PDF)
Jun 29, 2010	SUPPL -13	View Letter (PDF)
Oct 26, 2009	SUPPL -7	View Letter (PDF)
Aug 5, 2008	SUPPL -4	View Letter (PDF)
Mar 21, 2008	SUPPL -3	View Letter (PDF)
Jun 14, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 0.045MG/INH;EQ 0.021MG BASE/INH

RLD

0 patents0 exclusivities▴

AEROSOL, METERED;INHALATION | Approved: Jun 8, 2006

No patent or exclusivity listings for this strength.

#002 — 0.115MG/INH;EQ 0.021MG BASE/INH

RLD

0 patents0 exclusivities▾

AEROSOL, METERED;INHALATION | Approved: Jun 8, 2006

#003 — 0.23MG/INH;EQ 0.021MG BASE/INH

RLD

0 patents0 exclusivities▾

AEROSOL, METERED;INHALATION | Approved: Jun 8, 2006