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-four 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
Respirent Pharmaceuticals Co 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

FLOVENT HFA is protected by one US patents.

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	AB	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	021433-003	May 14, 2004
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-002	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
European Patent Office	1516283	INDICATEUR D'ACTIONNEMENT POUR DISPOSITIF DISTRIBUTEUR (ACTUATION INDICATOR FOR A DISPENSING DEVICE)
Japan	2007210680	DEVICE HOUSING FOR AEROSOL CONTAINER
Canada	2586146	MEDICAMENTS EN AEROSOL AVEC PROPULSEUR CONTENANT UN HYDROCARBURE FLUORE (FLUOROCARBON AEROSOL MEDICAMENTS)

Supplementary Protection Certificates for FLOVENT HFA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2506844	LUC00077	Luxembourg		PRODUCT NAME: PRODUIT DE COMBINAISON PHARMACEUTIQUE COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (PAR EXEMPLE LE BROMURE D'UMECLIDINIUM), LE VILANTEROL OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE (PAR EXEMPLE LE TRIFENATATE DE VILANTEROL) ET LE FUROATE DE FLUTICASONE; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117
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

Market Dynamics and Financial Trajectory for FLOVENT HFA

Last updated: February 20, 2026

What Is FLOVENT HFA and Its Market Position?

FLOVENT HFA (fluticasone propionate inhaler) is a corticosteroid used for asthma maintenance therapy. Approved by the FDA in 2006, it is marketed primarily by GSK. The inhaler has established itself as a key player in the inhaled corticosteroid segment.

Global Sales and Revenue Data

• 2022 Global Revenue: Approximately $1.2 billion.
• Market Share (Inhaled Corticosteroids, 2022): Estimated 15-20%, placing it among top inhalers for asthma management.
• Key Markets: U.S., Europe, Japan, emerging markets (Brazil, China).

What Are the Market Drivers?

Increasing Prevalence of Asthma and COPD

• Asthma affects 262 million worldwide, expected to rise annually by 3% ([1]).
• COPD prevalence is rising, necessitating effective inhaled corticosteroids.

Growing Adoption of Inhaler Therapies

• Elevated awareness among physicians of inhaled steroids' efficacy.
• Preference for inhalers over oral medications due to fewer systemic side effects.

Regulatory Approvals and Labeling

• Standard approval as maintenance therapy.
• Extended approvals in some regions for pediatric use.

Competitive Landscape

• Major competitors: Fluticasone propionate combined with salmeterol (Advair, Seretide), budesonide inhalers.
• Market entry barriers: Patent protections and patent expirations influence generic competition.

How Do Patent and Regulatory Dynamics Affect Market Trajectory?

Patent Expiry and Generic Competition

• Original patents expired in the U.S. in 2014-2016.
• Generic inhalers entered the market, leading to revenue decline.

Extended Patents and Data Exclusivity

• GSK secured patent extensions to delay generic entry until 2022.
• Data exclusivity limits generic competition in some regions until 2023.

Impact on Sales Post-Patent Expiration

• Sales declined 20-25% in the U.S. from 2016-2018.
• European markets experienced similar declines, stabilizing in recent years.

What Are Revenue Trends and Future Projections?

Historical Trajectory (2017-2022)

Year	Revenue (USD billions)	Notes
2017	1.3	Peak before patent expiry impact.
2018	1.2	Initial decline following patent expiry.
2019	1.0	Stabilization with generic competition.
2020	1.1	Slight rebound; increased use during COVID-19.
2021	1.2	Market stabilization; new formulations.
2022	1.2	Mature phase with steady sales.

Projected Outlook (2023-2027)

• Moderate growth anticipated, driven by new formulations and markets.
• Introduction of authorized generics expected to constrain pricing and revenue.
• Potential sales growth of 2-4% annually, reaching approximately $1.3 billion by 2027.

Key Factors Influencing Future Sales

• Launch of new, improved inhalers or corticosteroid formulations.
• Expansion into emerging markets with increasing asthma burden.
• Competition from generic inhalers and similar corticosteroids.
• Patent litigation and regulatory delays may influence timing.

What Are the Financial Risks and Opportunities?

Risks

• Erosion of brand exclusivity due to patent expiry.
• Price pressure from generics and biosimilars.
• Regulatory delays for new formulations.

Opportunities

• Differentiation through improved devices or formulations.
• Expansion into new geographic markets.
• Potential licensing or partnership agreements in emerging regions.

How Does the Competitive Landscape Shape Market Dynamics?

• GSK's strategic focus on attaching FloVent HFA with combination therapies (e.g., FLUTICASONE/salmeterol).
• Competition from generic inhalers, especially after patent expiration.
• Mergers and acquisitions in the inhaler space (e.g., Novartis and AstraZeneca alliances).

Regulatory Environment and Policy Impact

• Regulatory agencies in major markets (FDA, EMA) continue to streamline approval processes for new inhalers.
• Pricing and reimbursement policies influence market penetration, especially in health systems with strict cost controls.
• Global initiatives aim to increase access to inhaled corticosteroids in lower-income regions.

Key Takeaways

• FLOVENT HFA remains a significant inhaled corticosteroid but faces revenue pressures from patent expiries and generic competition.
• Growth depends on market expansion, new formulations, and regional penetration.
• Revenue stabilized at around $1.2 billion in recent years, with modest growth projected through 2027.
• Strategic focus on innovation, regional expansion, and brand management is essential to sustain profitability amid competitive and regulatory pressures.

FAQs

1. When did FLOVENT HFA lose its patent protection?
The original patents expired between 2014 and 2016 in the U.S. and Europe, leading to increased generic competition.

2. How does competition from generics affect FLOVENT HFA?
Generics are often sold at lower prices, reducing sales volume and profit margins for the brand.

3. Are there new formulations or combination therapies for FLOVENT HFA?
Yes, GSK has developed combination inhalers, which can create new revenue streams and market opportunities.

4. Which regions present the most growth opportunity for FLOVENT HFA?
Emerging markets, including China, Brazil, and India, have increasing asthma prevalence and expanding healthcare infrastructure.

5. What is the outlook for FLOVENT HFA’s market share?
It is expected to decline gradually due to generic competition but remain relevant through innovation and regional expansion.

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References

[1] Global Initiative for Asthma. (2022). Global Strategy for Asthma Management and Prevention. Retrieved from https://ginasthma.org