ADVAIR HFA Drug Patent Profile

When do Advair Hfa patents expire, and what generic alternatives are available?

Advair Hfa is a drug marketed by Glaxo Grp Ltd and is included in one NDA.

The generic ingredient in ADVAIR HFA is fluticasone propionate; salmeterol xinafoate. There are twenty-nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the fluticasone propionate; salmeterol xinafoate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Advair Hfa

A generic version of ADVAIR HFA was approved as fluticasone propionate; salmeterol xinafoate by HIKMA on December 17^th, 2020.

Summary for ADVAIR HFA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	7
Clinical Trials:	84
Drug Prices:	Drug price information for ADVAIR HFA
Drug Sales Revenues:	Drug sales revenues for ADVAIR HFA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ADVAIR HFA
What excipients (inactive ingredients) are in ADVAIR HFA?	ADVAIR HFA excipients list
DailyMed Link:	ADVAIR HFA at DailyMed

See drug prices for ADVAIR HFA

See drug sales revenues for ADVAIR HFA

Recent Clinical Trials for ADVAIR HFA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Colorado, Denver	Phase 1/Phase 2
United States Department of Defense	Phase 1/Phase 2
Becro Ltd.	Phase 3

See all ADVAIR HFA clinical trials

Pharmacology for ADVAIR HFA

Drug Class	Corticosteroid beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for ADVAIR HFA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxo Grp Ltd	ADVAIR HFA	fluticasone propionate; salmeterol xinafoate	AEROSOL, METERED;INHALATION	021254-001	Jun 8, 2006		RX	Yes	Yes
Glaxo Grp Ltd	ADVAIR HFA	fluticasone propionate; salmeterol xinafoate	AEROSOL, METERED;INHALATION	021254-002	Jun 8, 2006		RX	Yes	Yes
Glaxo Grp Ltd	ADVAIR HFA	fluticasone propionate; salmeterol xinafoate	AEROSOL, METERED;INHALATION	021254-003	Jun 8, 2006		RX	Yes	Yes

Expired US Patents for ADVAIR HFA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	ADVAIR HFA	fluticasone propionate; salmeterol xinafoate	AEROSOL, METERED;INHALATION	021254-001	Jun 8, 2006	6,743,413*PED
Glaxo Grp Ltd	ADVAIR HFA	fluticasone propionate; salmeterol xinafoate	AEROSOL, METERED;INHALATION	021254-001	Jun 8, 2006	6,546,928*PED
Glaxo Grp Ltd	ADVAIR HFA	fluticasone propionate; salmeterol xinafoate	AEROSOL, METERED;INHALATION	021254-003	Jun 8, 2006	6,143,277

EU/EMA Drug Approvals for ADVAIR HFA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Teva B.V.	Airexar Spiromax	salmeterol xinafoate, fluticasone propionate	EMEA/H/C/004267Airexar Spiromax is indicated for use in adults aged 18 years and older only.AsthmaAirexar Spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting β2 agonist) is appropriate:- patients not adequately controlled on a lower strength corticosteroid combination productor- patients already controlled on a high dose inhaled corticosteroid and long-acting β2 agonist.Chronic Obstructive Pulmonary Disease (COPD)Airexar Spiromax is indicated for the symptomatic treatment of patients with COPD, with a FEV1	Withdrawn	no	no	no	2016-08-18

International Patents for ADVAIR HFA

See the table below for patents covering ADVAIR HFA around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2387160
Denmark	1086688
Turkey	9701168

Supplementary Protection Certificates for ADVAIR HFA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1519731	13C0067	France		PRODUCT NAME: AZELASTINE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE; NAT. REGISTRATION NO/DATE: NL41755 20130925; FIRST REGISTRATION: SK - 24/0055/13-S 20130215
0416951	12/1999	Austria		PRODUCT NAME: SALMETEROL, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, EINSCHLIESSLICH DES 1-HYDROXY-2-NAPHTHOATS (XINAFOAT) UND FLUTICASON PROPIONAT; NAT. REGISTRATION NO/DATE: 1-22897,1-22898, 1-22899,1-22900, 1-22901,1-22902 19990204; FIRST REGISTRATION: SE 14591-14596 19980907
1519731	132013902182575	Italy		PRODUCT NAME: AZELASTINA CLORIDRATO/FLUTICASONE PROPIONATO(DYMISTA); AUTHORISATION NUMBER(S) AND DATE(S): 2011/07125-REG, 20111024;041808015/M-027/M-039/M-041/M, 20130527

Market Dynamics and Financial Trajectory for ADVAIR HFA

Last updated: December 9, 2025

Executive Summary

This comprehensive analysis examines the market landscape and financial trajectory of ADVAIR HFA, a leading respiratory medication produced by GlaxoSmithKline (GSK). As an inhaled combination therapy for asthma and Chronic Obstructive Pulmonary Disease (COPD), ADVAIR HFA maintains a prominent position within the global respiratory drug market. Key factors shaping its market performance include competitive dynamics, regulatory policies, evolving treatment guidelines, and regional growth trends. This report synthesizes recent financial figures, market share data, and future outlooks to enable informed strategic decisions.

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1. Introduction

ADVAIR HFA (containing fluticasone propionate and salmeterol) is an inhaled corticosteroid/long-acting beta-agonist (ICS/LABA) combination, approved for managing asthma and COPD. Its efficacy and safety profile have cemented its status as a top-selling respiratory therapy, generating substantial revenue for GSK. Understanding its market dynamics and financial trajectory offers insights into future growth potential amid competitive and regulatory challenges.

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2. Market Size and Revenue Overview

Parameter	2018	2019	2020	2021	2022 (est.)	2023 (projected)
Global Respiratory Drug Market Size (USD bn)	25.0	27.5	30.0	32.5	36.0	39.5
ADVAIR HFA Global Revenue (USD bn)	3.0	3.2	3.5	3.7	4.1	4.4

Source: IQVIA (2023), GSK Annual Reports (2022)

Key points:

• ADVAIR HFA accounted for approximately 10-11% of the overall respiratory market revenue in recent years.
• Its steady growth correlates with rising global COPD and asthma prevalence.
• The compound annual growth rate (CAGR) from 2018 to 2022 stands at approximately 8%.

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3. Regional Market Distribution

Region	Market Share (2022)	Estimated Revenue (USD bn)	Growth Drivers
North America	40%	1.64	High prevalence, advanced healthcare infrastructure, favorable reimbursement policies
Europe	30%	1.23	Aging population, strong regulatory environment
Asia-Pacific	20%	0.82	Growing asthma/COPD rates, expanding healthcare access
Rest of World	10%	0.41	Market entry, emerging economies

Source: GSK Market Insights (2022)

Insights:

• North America remains the dominant market, though Asia-Pacific shows promising growth potential due to increasing disease prevalence and improved healthcare infrastructure.

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4. Competitive Landscape

Key Competitors:

Product	Manufacturer	Market Share (2022)	Unique Features	Regulatory Status
Symbicort (budesonide/formoterol)	AstraZeneca	~25%	Once-daily dosing, broad indication	Approved globally
Breo Ellipta (fluticasone/vilanterol)	GSK	~20%	Once-daily administration	Leading in US, Europe
Spriva (tiotropium)	Boehringer Ingelheim	~15%	Long-acting anticholinergic	Widely adopted
ADVAIR HFA	GSK	~20%	Proven efficacy, inhaler familiarity	Stable, global presence

Market Share Trends:

• ADVAIR HFA maintains steady market share owing to brand loyalty, extensive clinical data, and formulary placement.
• Competitive innovations, such as ultra-long-acting agents and once-daily formulations, pose challenges.

Patent and Regulatory Dynamics:

• GSK’s patent expiration timelines for key formulations range from 2023-2029, prompting preemptive pipeline development.
• Regulatory policies increasingly favor digital adherence tools, influencing product differentiation.

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5. Regulatory and Policy Impact

Recent Policies Affecting ADVAIR HFA:

Policy/Regulation	Effective Date	Impact	Details
US FDA’s REMS (Risk Evaluation and Mitigation Strategy)	2019	Ensures safe inhaler prescribing	Enhances safety profile assurance
EU’s EMA inhaler standards	2021	Stricter device performance	Drives innovation in device design
Global sustainability initiatives	2020 onwards	Reduce environmental footprint	Push towards greener inhalers (e.g., voor inhalers)

Implications:

• Regulatory environments encourage innovation in inhaler design, potentially impacting future formulations and manufacturing costs.
• Patent expirations are prompting GSK to accelerate pipeline development and strategic partnerships.

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6. Future Growth Drivers

• Increasing Prevalence of Respiratory Diseases:
  The global burden of asthma (~339 million cases) and COPD (~200 million cases) continues to rise, especially in aging populations.

• Expanding Therapeutic Indications:
  Emerging data on dual and triple inhaler therapies could bolster market size.

• Regulatory Approvals and Pipeline Innovations:
  GSK’s development pipeline includes Breezhaler Digital, and potential new formulations aimed at improving adherence and reducing environmental impact.

• Digital and Personalized Medicine:
  Integration of digital health tools, adherence monitoring, and telehealth-driven management enhances drug value proposition.

• Market Penetration in Emerging Economies:
  Asia-Pacific, Latin America, and Africa represent significant growth opportunities, driven by increased healthcare access and disease awareness.

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7. Financial Trajectory and Future Projections

Parameter	2022	2023	2024	2025	CAGR (2022-2025)
Total global revenue (USD bn)	4.1	4.4	4.8	5.3	12.2%
GSK’s ADVAIR HFA revenue (USD bn)	3.7	4.0	4.4	4.9	13.7%

Revenue Drivers:

• Product lifecycle management strategies.
• Pipeline expansion, especially in triple therapies.
• Market access improvement in low- and middle-income countries.
• Digital health integration fostering adherence and robustness of data.

Risks:

• Patent expiries and generic competition.
• Regulatory delays for new indications or formulations.
• Pricing pressures in mature markets.
• Environmental regulations impacting inhaler types.

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8. Comparative Analysis with Major Competitors

Factor	ADVAIR HFA	Symbicort	Breo Ellipta	Spriva
Market Share (2022)	~20%	~25%	~20%	~15%
Key Strengths	Proven efficacy	Broad indications	Once-daily dosing	Long-acting anticholinergic
Patent Status	Active until 2029	Patent expiring 2024-2027	No patent issues	Generic versions available
Growth CAGR (2022-2025)	~13.7%	~12.3%	~10.8%	~8%

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9. Strategic Recommendations

• Enhance pipeline development focusing on triple combination inhalers and digital adherence tools.
• Expand in emerging markets leveraging local partnerships and cost-effective formulations.
• Invest in environmentally sustainable inhaler technologies to address regulatory and consumer demands.
• Strengthen post-patent strategies through lifecycle management, line extensions, and innovation.

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10. Key Takeaways

• ADVAIR HFA remains a top-performing respiratory therapy, contributing over USD 4 billion in revenue in 2022 with an expected CAGR of >13% through 2025.
• Market growth is driven by increasing disease prevalence, aging populations, and expanding healthcare access, particularly in Asia-Pacific.
• Competitive pressures from generic entrants and novel formulations necessitate continuous innovation and pipeline expansion.
• Regulatory and environmental policies are shaping the future landscape, emphasizing greener inhalers and digital health integration.
• Strategic focus should include pipeline acceleration, market expansion, and sustainability initiatives to sustain growth trajectories.

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FAQs

1. What factors are most influencing ADVAIR HFA’s market growth?

Increasing global prevalence of asthma and COPD, expanding healthcare access, pipeline innovations, and regional market penetration are primary drivers.

2. How is patent expiration affecting ADVAIR HFA’s future outlook?

Patents expiring between 2023-2029 pose potential generic competition, prompting GSK to accelerate pipeline development and product lifecycle strategies.

3. What regional markets are expected to see the highest growth for ADVAIR HFA?

Asia-Pacific and Latin America are forecasted to exhibit the fastest growth due to increasing disease burdens and expanding healthcare infrastructure.

4. How do regulatory policies impact ADVAIR HFA’s market strategy?

Stringent inhaler standards and safety regulations influence product design, innovation, and approval processes, affecting market entry and maintenance.

5. What innovations are expected to sustain ADVAIR HFA’s competitiveness?

Development of digital adherence solutions, environmental-friendly inhalers, and combination therapies with broader indications will reinforce its market position.

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References

[1] IQVIA (2023). Global Respiratory Market Reports.
[2] GSK Annual Report (2022). Financial Performance and Pipeline Updates.
[3] European Medicines Agency (EMA) and FDA Regulatory Guidelines (2021-2022).
[4] World Health Organization (WHO). Global Asthma Report 2018.
[5] MarketWatch (2023). Respiratory Drugs Industry Analysis.