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VENTOLIN HFA

NDA

ALBUTEROL SULFATE | N020983 | GLAXOSMITHKLINE INTELLECTUAL PROPERTY LTD ENGLAND

1 strength0 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

175 trials from ClinicalTrials.gov — 1 recruiting, 1 active, 139 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Secondhand Smoke Respiratory Health Study NCT02797275	Phase 4	Active	University of California, San Francisco	107	2016-06-06 → 2026-12-31
Nebulized or Inhaled Albuterol for Lymphangioleiomyomatosis NCT01799538	Phase 1/2	Recruiting	National Heart, Lung, and Blood Institute (NHLBI)	100	2013-06-10 → 2027-11-01
Efficacy and Safety Study of RAGWITEK™ (MK-3641) in Children With Ragweed-Induced Rhinoconjunctivitis With or Without Asthma (MK-3641-008)NCT02478398	Phase 3	Completed	Merck Sharp & Dohme LLC	1,025	2015-07-20 → 2018-11-19
Lung Function Changes of Induced Asthma Children Treated With Inhaled MgSO4 NCT01856959	N/A	Completed	Chongqing Medical University	330	2011-11 → 2013-05
Evaluation of Dupilumab in Patients With Persistent Asthma (Liberty Asthma Quest)NCT02414854	Phase 3	Completed	Sanofi	1,902	2015-04-27 → 2017-11-23
Exercise Induced Bronchospasm in Children NCT00273689	Phase 4	Completed	University of New Mexico	13	2005-12 → 2007-09
Effect of Pre-Treatment With Cromolyn or Albuterol on Response to PUL-042 Inhalation Solution (PUL-042)NCT02566252	Phase 1	Completed	Pulmotect, Inc.	16	2015-07 → 2016-03
A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) in Adults and Children 4 Years of Age or Older With Asthma NCT03769090	Phase 3	Completed	Bond Avillion 2 Development LP	3,132	2018-12-13 → 2022-02-07
An Evaluation of Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma NCT01854047	Phase 2	Completed	Sanofi	776	2013-06 → 2015-04
Airway and Pulmonary Vascular Endothelial Function in Healthy Smokers: Effect of Inhaled Glucocorticosteroid Treatment NCT02141633	N/A	Completed	University of Miami	31	2013-04 → 2015-12

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs (2 brand, 1 generic)

Highest NADAC/Unit

$3.04

per gm

Lowest NADAC/Unit

$1.83

per gm

Brand NDCs

Generic NDCs

Avg Brand: $2.88

Avg Generic: $1.83

36% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00173068220VENTOLIN HFA 90 MCG INHALER	$3.04	GM	Brand	$1.83	2026-06-17
00173068224VENTOLIN HFA 90 MCG INHALER	$2.72	GM	Brand	—	2026-06-17
66993001968ALBUTEROL HFA 90 MCG INHALER	$1.83	GM	Generic	—	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (3 FSS, 3 Big4)

Lowest Price

$16.40

Highest Price

$50.42

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
66993-0019-68ALBUTEROL 90MCG/ACTUAT (CFC-F) INHL,ORAL,18GM	$35.62	FSS	Prasco, LLC	06/30/2026
66993-0019-68ALBUTEROL 90MCG/ACTUAT (CFC-F) INHL,ORAL,18GM	$23.70	Big4	Prasco, LLC	06/30/2026
00173-0682-20VENTOLIN HFA INHL,ORAL	$50.42	FSS	GlaxoSmithKline	07/31/2027
00173-0682-20VENTOLIN HFA INHL,ORAL	$41.83	Big4	GlaxoSmithKline	07/31/2027
00173-0682-24VENTOLIN HFA	$20.10	FSS	GlaxoSmithKline	07/31/2027
00173-0682-24VENTOLIN HFA	$16.40	Big4	GlaxoSmithKline	07/31/2027

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

Medicare Part D Spending

CMS annual spending data for Ventolin HFA (2024)

Total Spending

$152.9M

Total Claims

2,272,575

Beneficiaries

850,779

Avg Cost/Unit

$3.05

Spending Trend

$499.8M(2019)→$314.3M(2020)→$195.5M(2021)→$170.3M(2022)→$192.5M(2023)→$152.9M(2024)

YoY Change:-9.3%

5yr CAGR:-0.7%

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

API Supply Chain12 active DMFs1 inactive

11 active API suppliers hold Drug Master Files for this ingredient.

CIPLA LTDALBUTEROL SULFATE USP

DMF 68851987

FDC LTDALBUTEROL SULFATE USP

DMF 78091988

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGALBUTEROL SULFATE (UNMICRONIZED)

DMF 142581999

NEULAND LABORATORIES LTDALBUTEROL SULFATE USP

DMF 163712003

CIPLA LTDALBUTEROL SULFATE USP

DMF 166782003

MELODY HEALTHCARE PVT LTDALBUTEROL SULFATE USP

DMF 265622012

LUSOCHIMICA SPAALBUTEROL SULFATE

DMF 289972015

SUPRIYA LIFESCIENCE LTDALBUTEROL SULFATE USP

DMF 307082016

PEARL THERAPEUTICS INCALBUTEROL SULFATE PRESSURISED INHALATION AEROSOL AND MATCHING PLACEBO

DMF 319952017

OLON SPAALBUTEROL SULFATE

DMF 341752020

LUPIN LTDALBUTEROL SULFATE

DMF 396822024

VAMSI LABS LTDALBUTEROL SULFATE USP

DMF 425932025

NEULAND LABORATORIES LTDInactiveALBUTEROL SULFATE

DMF 102541993

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Aug 19, 2021	SUPPL -41	View Letter (PDF)
Dec 19, 2019	SUPPL -36	View Letter (PDF)
Dec 23, 2014	SUPPL -32	View Letter (PDF)
Sep 7, 2012	SUPPL -27	View Letter (PDF)
Apr 2, 2008	SUPPL -16	View Letter (PDF)
Apr 28, 2005	SUPPL -9	View Letter (PDF)
Apr 19, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.09MG BASE/INH

RLDAB3

0 patents0 exclusivities▴

AEROSOL, METERED;INHALATION | Approved: Apr 19, 2001

No patent or exclusivity listings for this strength.