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-one 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 FOUGERA PHARMS on May 14^th, 2004.

Summary for FLOVENT HFA

International Patents:	29
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	38
Patent Applications:	2,813
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					Y
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-001	May 14, 2004		RX	Yes	Yes					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
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-001	May 14, 2004
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-003	May 14, 2004

International Patents for FLOVENT HFA

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	9936115
Japan	3487866
European Patent Office	0717987	Formulations d'aérosol en suspension (Suspension aerosol formulations)

Supplementary Protection Certificates for FLOVENT HFA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
1305329	SPC/GB08/026	United Kingdom		PRODUCT NAME: FLUTICASONE FUROATE AND SOLVATES THEREOF; REGISTERED: UK EU/1/07/434/001 20080116; UK EU/1/07/434/002 20080116; UK EU/1/07/434/003 20080116

Market Dynamics and Financial Trajectory of FLOVENT HFA

Last updated: July 3, 2025

Introduction

FLOVENT HFA, a cornerstone inhaler for asthma management, has shaped the respiratory pharmaceuticals market since its launch. Developed by GlaxoSmithKline (GSK), this fluticasone propionate-based drug helps millions control inflammation in their airways. As patents near expiration and generics emerge, understanding its market dynamics and financial path is crucial for investors and healthcare executives navigating an evolving industry. This analysis delves into current trends, competitive pressures, and revenue forecasts, offering insights to inform strategic decisions.

Overview of FLOVENT HFA

FLOVENT HFA stands out as a metered-dose inhaler delivering corticosteroids to treat asthma in patients aged 4 and older. Approved by the U.S. Food and Drug Administration (FDA) in 2004, it addresses persistent asthma by reducing airway swelling, positioning it as a key player in the global respiratory market. GSK's innovation in formulation has sustained its relevance, but shifting healthcare policies and patient preferences now influence its trajectory. Analysts track FLOVENT HFA for its role in a $20 billion asthma treatment sector, where efficacy and accessibility drive demand.

The drug's patent landscape adds complexity. The original composition patent expired in 2017, opening doors for generics, yet GSK maintains secondary protections through device design and combination therapies. This dynamic underscores the need for stakeholders to monitor regulatory shifts, as they directly impact market share and profitability.

Market Dynamics

Current Market Size and Growth Drivers

The asthma therapeutics market, valued at approximately $28 billion globally in 2023, continues to expand at a compound annual growth rate (CAGR) of 4.5% through 2030, according to recent industry data. FLOVENT HFA captures a notable segment, with U.S. sales alone exceeding $1.5 billion annually before generic erosion. Rising asthma prevalence—affecting over 262 million people worldwide—fuels this growth, particularly in emerging markets like Asia-Pacific, where urbanization and pollution increase respiratory conditions.

Key drivers include heightened awareness of asthma management and the shift toward combination inhalers. FLOVENT HFA benefits from its established safety profile, but challenges arise from biosimilar threats and payer pressures for cost-effective alternatives. In the U.S., the Inflation Reduction Act has intensified scrutiny on drug pricing, potentially capping FLOVENT HFA's growth. Conversely, partnerships with telehealth providers expand access, boosting adoption in underserved regions.

Competitive Landscape

Competition intensifies as generics from players like Teva Pharmaceuticals and Mylan enter the fray. FLOVENT HFA faces direct rivals such as AstraZeneca's Symbicort and Boehringer Ingelheim's Spiriva, which offer similar efficacy with added conveniences like once-daily dosing. Market share data from IQVIA reveals FLOVENT HFA held about 15% of the U.S. inhaled corticosteroid market in 2023, down from 20% in 2019, reflecting generic penetration.

Strategic alliances and acquisitions reshape this landscape. GSK's 2022 merger with Haleon strengthened its consumer health portfolio, indirectly supporting FLOVENT HFA by enhancing distribution networks. However, emerging biologics like Tezspire from Amgen threaten to erode market space by targeting severe asthma more precisely. Executives must weigh these factors, as pricing wars and formulary exclusions could reduce FLOVENT HFA's premium positioning.

Regulatory and External Factors

Regulatory hurdles play a pivotal role in FLOVENT HFA's market dynamics. The FDA's ongoing reviews, including post-market surveillance for side effects like oral thrush, maintain pressure on GSK to innovate. In Europe, the European Medicines Agency (EMA) enforces strict environmental standards, prompting GSK to reformulate for lower carbon footprints, which could delay product updates.

External influences, such as the COVID-19 pandemic, accelerated telemedicine adoption, increasing FLOVENT HFA prescriptions through virtual consultations. Yet, supply chain disruptions in 2022 highlighted vulnerabilities, with shortages impacting 10% of U.S. pharmacies. Global trade policies, including U.S.-China tariffs, further complicate raw material sourcing for GSK, potentially inflating costs and slowing market expansion.

Financial Trajectory

Historical Sales Performance

FLOVENT HFA's financial history reflects GSK's respiratory dominance, with peak U.S. revenues hitting $2.1 billion in 2015. By 2023, sales dipped to $1.2 billion, a 43% decline attributed to patent expirations and generic competition. GSK's annual reports show that North America accounted for 70% of FLOVENT HFA's revenue, underscoring its market reliance on high-income regions.

Profit margins, once robust at 65%, have contracted to around 50% due to pricing rebates and marketing expenses. This trajectory mirrors broader pharma trends, where blockbuster drugs like FLOVENT HFA face revenue cliffs post-patent. Investors note that GSK offset these losses through diversification, with total company revenues growing 5% year-over-year in 2023.

Revenue Projections and Risks

Looking ahead, analysts project FLOVENT HFA's global revenues to stabilize at $800 million by 2027, assuming a 3% CAGR amid generic dominance. Optimism stems from GSK's pipeline, including next-generation inhalers that could extend the brand's lifecycle. However, risks abound: U.S. price negotiations under the Inflation Reduction Act may slash reimbursements by up to 20%, per Deloitte forecasts.

Financial models from Evaluate Pharma estimate a best-case scenario where FLOVENT HFA revenues hold steady through branded-generic hybrids, but a worst-case involves a 50% drop if low-cost alternatives flood the market. Currency fluctuations and economic downturns add volatility, as seen in GSK's 10% earnings dip in 2022 due to inflation.

Impact of Patents and Generics

Patent strategies define FLOVENT HFA's financial future. While the core patent expired, GSK secured extensions via device innovations, pushing protection to 2028 in some regions. This has delayed generic full-scale entry, preserving cash flows. Yet, legal battles, such as the 2021 FDA approval of a Teva generic, signal inevitable erosion.

Generics now command 40% of the U.S. market, compressing margins and forcing GSK to pivot toward value-added services like patient support programs. Financial experts at Goldman Sachs predict that without new indications, FLOVENT HFA could lose 60% of its value by 2030, emphasizing the need for R&D investments to mitigate this trajectory.

Conclusion

In summary, FLOVENT HFA navigates a complex interplay of market forces and financial shifts, with generics and regulations posing significant challenges. GSK's adaptive strategies offer a pathway to sustained relevance, but stakeholders must act decisively to capitalize on opportunities in a competitive landscape.

Key Takeaways

• FLOVENT HFA's market share in asthma treatments has declined due to generics, but it remains a key revenue driver for GSK in respiratory care.
• Global asthma prevalence drives demand, yet regulatory pressures and pricing reforms could reduce revenues by up to 50% in the next five years.
• Patent extensions provide temporary financial stability, but innovation in device technology is essential for long-term growth.
• Competition from biologics and combination therapies intensifies, requiring GSK to enhance marketing and partnerships.
• Investors should monitor U.S. policy changes, as they directly influence FLOVENT HFA's profitability and market dynamics.

FAQs

1. What factors are driving the decline in FLOVENT HFA sales? The primary drivers include patent expirations, increased generic competition, and regulatory pricing pressures, which have collectively reduced market share since 2017.
2. How does FLOVENT HFA compare to its competitors in terms of efficacy? FLOVENT HFA offers reliable inflammation control for asthma, but rivals like Symbicort provide dual-action benefits, potentially making them more appealing for certain patients.
3. What role do patents play in FLOVENT HFA's financial future? Patents on device formulations extend protection until 2028, helping maintain revenues, but their expiration will likely accelerate generic adoption and revenue drops.
4. How has the COVID-19 pandemic affected FLOVENT HFA's market? The pandemic boosted telehealth prescriptions, temporarily increasing demand, but supply chain issues led to shortages that impacted sales in 2022.
5. What strategies can GSK use to improve FLOVENT HFA's financial trajectory? GSK could focus on R&D for advanced formulations, expand into emerging markets, and leverage partnerships to offset generic threats and sustain profitability.

Sources

1. GSK Annual Report 2023. Available from GSK corporate website.
2. IQVIA Market Prognosis Report on Asthma Therapeutics, 2023.
3. FDA Drug Approval Database for FLOVENT HFA, accessed 2024.
4. Evaluate Pharma Financial Forecasts for Respiratory Drugs, 2024 edition.
5. Deloitte Analysis of U.S. Pharmaceutical Pricing Reforms, 2023.