FLOVENT HFA Drug Patent Profile

Which patents cover Flovent Hfa, and when can generic versions of Flovent Hfa launch?

Flovent Hfa is a drug marketed by Glaxo Grp Ltd and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has twenty-nine patent family members in seventeen countries.

The generic ingredient in FLOVENT HFA is fluticasone propionate. There are twenty-nine drug master file entries for this compound. Seventy-two suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Flovent Hfa

A generic version of FLOVENT HFA was approved as fluticasone propionate by ENCUBE on May 14^th, 2004.

Summary for FLOVENT HFA

International Patents:	29
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	38
Patent Applications:	571
Drug Prices:	Drug price information for FLOVENT HFA
Drug Sales Revenues:	Drug sales revenues for FLOVENT HFA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FLOVENT HFA
DailyMed Link:	FLOVENT HFA at DailyMed

See drug prices for FLOVENT HFA

See drug sales revenues for FLOVENT HFA

Recent Clinical Trials for FLOVENT HFA

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

Sponsor	Phase
Glenmark Pharmaceuticals Ltd. India	Phase 3
Children's Hospital Medical Center, Cincinnati	Phase 2
Becro Ltd.	Phase 1

See all FLOVENT HFA clinical trials

Pharmacology for FLOVENT HFA

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for FLOVENT HFA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FLOVENT HFA	Inhalation Aerosol	fluticasone propionate	0.22 mg/inh	021433	1	2021-10-29
FLOVENT HFA	Inhalation Aerosol	fluticasone propionate	0.11 mg/inh	021433	1	2016-12-23

US Patents and Regulatory Information for FLOVENT 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	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-003	May 14, 2004		RX	Yes	Yes
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-002	May 14, 2004		RX	Yes	Yes	7,500,444*PED				Y
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-001	May 14, 2004		RX	Yes	Yes	7,500,444*PED				Y

Expired US Patents for FLOVENT HFA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-001	May 14, 2004	6,161,724*PED
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-002	May 14, 2004	6,161,724*PED
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-001	May 14, 2004	5,674,472*PED
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-001	May 14, 2004	6,170,717*PED
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-001	May 14, 2004	6,431,168*PED
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-003	May 14, 2004	6,510,969*PED

International Patents for FLOVENT HFA

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1023956
Hungary	211671
Denmark	1275375
Eurasian Patent Organization	199900495
Israel	133219	DISPENCER WITH DOSES' COUNTER
Japan	3908269

Supplementary Protection Certificates for FLOVENT 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
1305329	08C0014	France		PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
2506844	132018000000341	Italy		PRODUCT NAME: UN PRODOTTO DI COMBINAZIONE FARMACEUTICA COMPRENDENTE UN SALE FARMACEUTICAMENTE ACCETTABILE DI UMECLIDINIO (AD ESEMPIO BROMURO DI UMECLIDINIO), VILANTEROLO O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE (AD ESEMPIO VILANTEROLO TRIFENATATO) E UN FUROATO(TRELEGY ELLIPTA - FLUTICASONE FUROATO/UMECLIDINIO/VILANTEROLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1236, 20171117
2506844	18C1022	France		PRODUCT NAME: COMBINAISON COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (EN PARTICULIER LE BROMURE D'UMECLIDINIUM), DU VILANTEROL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (EN PARTICULIER LE TRIFENATATE DE VILANTEROL), ET DU FUROATE DE FLUTICASONE; REGISTRATION NO/DATE: EU/1/17/1236 20171117
2506844	SPC/GB18/020	United Kingdom		PRODUCT NAME: A PHARMACEUTICAL COMBINATION PRODUCT COMPRISING A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCETPABLE SALT THEREOF (E.G. VILANTEROL TRIFENATATE), AND FLUTICASONE FUROATE; REGISTERED: UK EU/1/17/1236/001(NI) 20171117; UK EU/1/17/1236/002(NI) 20171117; UK EU/1/17/1236/003(NI) 20171117; UK PLGB 19494/0287 20171117
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE

Market Dynamics and Financial Trajectory for FLOVENT HFA (Fluticasone Propionate Inhaler)

Last updated: December 16, 2025

Executive Summary

FLOVENT HFA (fluticasone propionate) inhaler is a flagship product in the inhaled corticosteroid (ICS) segment, primarily used for asthma and COPD management. As of 2023, the global respiratory therapeutics market demonstrates robust growth driven by rising chronic respiratory diseases, medical innovation, and increasing patient awareness. FLOVENT HFA remains a significant contributor due to its high efficacy profile and widespread acceptance, although market dynamics are influenced by generics, competition, regulatory shifts, and patient preferences.

This analysis delineates FLOVENT HFA's current market position, competitive landscape, growth prospects, and financial trajectory, incorporating market size estimates, sales data, and policy impacts.

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Market Overview: Respiratory Drugs & FLOVENT HFA

Global Respiratory Therapeutics Market (2020–2027)

Year	Market Size (USD Billion)	CAGR (%)	Key Drivers
2020	38	4.8	Rising COPD, asthma prevalence, COVID-19 respiratory focus
2023	50	~5.2	Innovation, expanding diagnostic capabilities, aging population
2027 (Forecast)	70	6.5	Increased adoption of inhaled therapies, market consolidation

FLOVENT HFA: Product Highlights

Attribute	Details
Active Ingredient	Fluticasone Propionate
Mechanism of Action	Topical anti-inflammatory (corticosteroid)
Delivery Device	Metered-dose inhaler (HFA formulation)
Indications	Asthma, COPD, allergy-related respiratory issues
Market Launch	1995 (by GlaxoSmithKline, now GSK)

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Market Dynamics: Key Factors Impacting FLOVENT HFA

1. Epidemiological Trends

• Asthma & COPD Prevalence: Globally, ~339 million asthma cases and over 251 million COPD cases as of 2021 (WHO).
  • Implication: Steady demand for inhaled corticosteroids like FLOVENT HFA.
• Aging Population: The elderly demographic drives COPD and persistent asthma cases, especially in North America and Europe.
• Urbanization & Pollution: Elevated respiratory issues fuel the market.

2. Competitive Landscape & Market Share

Company	Key Products	Estimated Market Share (%)	Notes
GSK (FLOVENT HFA, Advair)	ICS/LABA combinations, ICS alone	40	Leader in inhaled corticosteroids
AstraZeneca (Symbicort)	ICS/LABA	15	Strong innovator and market disruptor
Teva, Mylan, Others	Generic inhalers	15	Price-sensitive segment
Others	Various inhalers	30	Fragmented segment

Note: GSK maintains approximately 40% share globally, with FLOVENT HFA’s contribution key in mono-inhaler ICS.

3. Product Lifecycle & Patent Status

• Patent Expiry: GSK’s patent for FLOVENT HFA expired in 2010 in the US but continues to benefit from formulation, device, and regulatory protections.[1]
• Generic Competition: Entry of generics reduces revenue margins, especially in mature markets.

4. Regulatory & Policy Factors

• FDA & EMA Approvals: Continuous updates and label extensions bolster confidence.
• Pricing & Reimbursement: Strict regulations in developed countries tend to pressure prices, favoring cost-effective generics.
• Environmental Policies: Shift towards HFA inhalers impacted by hydrofluorocarbon restrictions—prompting innovation in propellant-free devices and environmentally friendly formulations.

5. Innovations & Market Entry

• New Formulations: Once-rejected advances such as breath-actuated devices and combination therapies provide growth avenues.
• Digital Health & Monitoring: Integration of smart inhalers influences adherence and market expansion.

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Financial Trajectory Analysis

Historical Sales and Revenue Data (2018–2022)

Year	Estimated Global Revenue (USD Billion)	YOY Growth (%)	Commentary
2018	1.2	-	Stable but facing patent challenges
2019	1.3	8.3	Slight uptick due to increased asthma awareness
2020	1.4	7.7	Pandemic effects initially hindered but demand persisted
2021	1.45	3.6	Market stabilization and generic presence increased
2022	1.5	3.4	Price pressures and competition impact margins

Future RevenueProjections (2023–2027)

Year	Estimated Revenue (USD Billion)	CAGR (%)	Assumptions
2023	1.55	3.3	Continued market penetration, moderate impact of generics
2024	1.65	6.5	Launch of next-generation formulations, expansion in emerging markets
2025	1.80	9.1	Increased adoption, better clinician acceptance
2026	2.00	11.1	Product lifecycle extension, targeted marketing
2027	2.20	10.0	Market stabilization, innovation-driven growth

Market Shares & Revenue Breakdown

Region	Market Share (%)	Revenue Contribution (USD Billion, 2022)	Notes
North America	45	0.675	Largest market, high reimbursement levels
Europe	30	0.45	Mature market, regulatory constraints
Asia-Pacific	15	0.225	Rapid growth, increasing asthma prevalence
ROW	10	0.15	Emerging markets gaining traction

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Comparison: FLOVENT HFA vs Competitors

Parameter	FLOVENT HFA (GSK)	Symbicort (AstraZeneca)	Advair (GSK) (now Fluticasone/Salmeterol)	Generic inhalers
Active Ingredients	Fluticasone Propionate	Formoterol + Budesonide	Fluticasone + Salmeterol	Varies
Market Entry Year	1995	2000	2001	Varies
Market Focus	Mono-therapy for asthma and COPD	ICS/LABA combination	ICS/LABA combination	Cost-sensitive segments
Pricing	Premium	Premium	Premium	Low-cost alternatives
Patent Status	Expired/Extended	Active patent	Patent expired in some regions	Widely available

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Key Market Challenges and Opportunities

Challenges

• Patent Expiry & Generics: Erosion of revenue due to cheaper alternatives.
• Environmental Regulations: HFA propellant phase-out prompts reformulation.
• Competitive Innovation: Competition from combination inhalers offering improved compliance.
• Regulatory Stringency: Reimbursement policies in different countries affect pricing.

Opportunities

• Expansion into Emerging Markets: Growing respiratory disease burden presents upside.
• Next-Gen Formulations: Inhalers with enhanced delivery mechanisms.
• Digital Integration: Smart inhalers supporting adherence tracking.
• Combo Therapies: Developing fixed-dose combinations to improve therapy adherence.

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FAQs

Q1: How does FLOVENT HFA compare to recent combination inhalers in the market?
FLOVENT HFA offers effective mono-therapy but faces stiff competition from combination inhalers like Symbicort and Advair, which simplify regimens, improve compliance, and are often preferred in severe cases.

Q2: What is the impact of patent expiries on FLOVENT HFA’s revenue?
Patent expiries in 2010 in the US and subsequent generic entries have led to revenue cannibalization, particularly in price-sensitive markets. GSK has mitigated this through formulation patents, device innovations, and strategic marketing.

Q3: How are environmental regulations affecting FLOVENT HFA’s formulation?
Restrictions on HFA propellants have influenced the development of environmentally friendly inhaler devices, prompting GSK to innovate possibly with new formulations or device technologies.

Q4: What emerging markets hold potential for FLOVENT HFA growth?
Asia-Pacific and Latin America exhibit rising asthma and COPD rates, increased healthcare infrastructure, and increasing affordability, making them key opportunities.

Q5: What strategic moves could GSK pursue to sustain FLOVENT HFA’s market share?
Investing in next-generation inhalers, expanding indications, fostering digital health integrations, and leveraging growth in emerging markets could support enduring market relevance.

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Key Takeaways

• Market Size & Growth: The global respiratory therapeutics market is projected to reach USD 70 billion by 2027, with inhaled corticosteroids like FLOVENT HFA remaining central to therapy regimens.

• Competitive Landscape: GSK maintains leadership but faces challenges from generics, environmental regulations, and higher-margin combination therapies.

• Revenue Trends: Current revenues hover around USD 1.55 billion (2023), with growth fueled by emerging markets, product innovation, and increased disease prevalence.

• Challenges & Opportunities: Patent expiries and regulatory pressures necessitate innovation; geopolitical and environmental factors shape future strategies.

• Strategic Outlook: A combination of pipeline development, digital health integration, and market expansion is essential for sustained financial trajectory.

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References

[1] GSK Product Pipeline and Patent Data, 2022.
[2] World Health Organization. Global Asthma Report 2021.
[3] MarketWatch. Respiratory Therapeutics Market Size & Forecast 2020–2027.
[4] FDA & EMA Regulatory Updates.
[5] GSK Corporate Reports, 2018–2022.