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

89 trials from ClinicalTrials.gov — 1 recruiting, 81 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Versus Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma.NCT05776927	Phase 3	Recruiting	Novartis Pharmaceuticals	188	2026-08-04 → 2029-01-30
Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable Tablets NCT00328718	Phase 3	Completed	GlaxoSmithKline	526	2005-10 → 2007-04
Seretide Versus Flixotide In Asthmatic Children Not Controlled By Inhaled Corticosteroids NCT00353873	Phase 4	Completed	GlaxoSmithKline	506	2005-11-18 → 2006-10-26
A 3 Way Cross-over Study Evaluating the Effects of ADOAIR Twice Daily Plus Tiotropium Bromide Once Daily Compared With the Individual Treatments of Japanese Subjects NCT01751113	Phase 4	Completed	GlaxoSmithKline	53	2013-02 → 2013-11
A Bioequivalence Study Between Fluticasone and Salmeterol vs. SERETIDE DISKUS® in Healthy Volunteers With Charcoal Blockade NCT04124094	Phase 1	Completed	Respirent Pharmaceuticals Co Ltd.	36	2019-10-01 → 2020-06-09
Advair HFA For Chronic Obstructive Pulmonary Disease(COPD)NCT00633217	Phase 4	Completed	GlaxoSmithKline	247	2008-03 → 2009-02
Strategy for Early Treatment of Exacerbations in COPD: Standing Prescriptions of Advair With a Written Action Plan in the Event of an Exacerbation NCT02136875	Phase 4	Completed	McGill University Health Centre/Research Institute of the McGill University Health Centre	37	2008-07 → 2010-08
Repeat Dose Study of Fluticasone Propionate/Salmeterol Versus Fluticasone Propionate + Salmeterol In Asthmatics NCT00364442	Phase 1	Completed	GlaxoSmithKline	12	2005-01-28 → 2005-04-13
A Study Measuring Asthma Control In Pediatric And Adolescent Subjects Whose Asthma Is Worsened By Activity Or Exercise NCT00118690	Phase 4	Completed	GlaxoSmithKline	227	2003-12 → 2005-12
Sub-Sensitivity to Long-Acting Bronchodilators (LABA)NCT01117116	N/A	Completed	National Jewish Health	20	2010-03 → 2013-09

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 | 9 NDCs (6 brand, 3 generic)

Highest NADAC/Unit

$35.02

per gm

Lowest NADAC/Unit

$16.85

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	$35.02	GM	Brand	$27.08	2026-08-19
00173071722ADVAIR HFA 230-21 MCG INHALER	$30.61	GM	Brand	—	2026-08-19
66993008896FLUTICASONE-SALMETEROL 230-21	$27.08	GM	Generic	—	2026-08-19
00173071620ADVAIR HFA 115-21 MCG INHALER	$25.42	GM	Brand	$20.97	2026-08-19
66993008796FLUTICASONE-SALMETEROL 115-21	$20.97	GM	Generic	—	2026-08-19
00173071522ADVAIR HFA 45-21 MCG INHALER	$20.07	GM	Brand	—	2026-08-19

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
66993-0086-96FLUTICASONE 45MCG/SALMETEROL 21MCG INHL,ORAL	$133.34	Big4	Prasco, LLC	06/30/2026
66993-0086-96FLUTICASONE 45MCG/SALMETEROL 21MCG INHL,ORAL	$210.72	FSS	Prasco, LLC	06/30/2026
66993-0087-96FLUTICASONE 115MCG/SALMETEROL 21MCG INHL,ORAL	$165.72	Big4	Prasco, LLC	06/30/2026
66993-0087-96FLUTICASONE 115MCG/SALMETEROL 21MCG INHL,ORAL	$261.83	FSS	Prasco, LLC	06/30/2026
66993-0088-96FLUTICASONE 230MCG/SALMETEROL 21MCG INHL,ORAL	$218.69	Big4	Prasco, LLC	06/30/2026
66993-0088-96FLUTICASONE 230MCG/SALMETEROL 21MCG INHL,ORAL	$344.35	FSS	Prasco, LLC	06/30/2026

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