Fluticasone propionate - Generic Drug Details

What are the generic sources for fluticasone propionate and what is the scope of freedom to operate?

Fluticasone propionate is the generic ingredient in twenty branded drugs marketed by Glaxosmithkline, Glaxo Grp Ltd, Fougera Pharms, Cosette, Encube, Nesher Pharms, Padagis Israel, Glenmark Pharms Ltd, Bright, Chartwell Rx, Taro Pharm Inds, Teva Pharm, Haleon Us Holdings, Apotex, Aurobindo Pharma Ltd, Hikma, Rubicon Research, Optinose Us Inc, Teva Pharms Usa, and Mylan, and is included in thirty-eight NDAs. There are forty-five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fluticasone propionate has eight hundred and fourteen patent family members in forty countries.

There are twenty-four drug master file entries for fluticasone propionate. Seventy-one suppliers are listed for this compound.

Summary for fluticasone propionate

International Patents:	814
US Patents:	45
Tradenames:	20
Applicants:	20
NDAs:	38
Drug Master File Entries:	24
Finished Product Suppliers / Packagers:	71
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	365
Patent Applications:	6,642
Drug Prices:	Drug price trends for fluticasone propionate
Drug Sales Revenues:	Drug sales revenues for fluticasone propionate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fluticasone propionate
What excipients (inactive ingredients) are in fluticasone propionate?	fluticasone propionate excipients list
DailyMed Link:	fluticasone propionate at DailyMed

See drug prices for fluticasone propionate

See drug sales revenues for fluticasone propionate

Recent Clinical Trials for fluticasone propionate

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

Sponsor	Phase
Eurofarma Laboratorios S.A.	Phase 3
Humanis Saglık Anonim Sirketi	Phase 1
Sanofi	Phase 3

See all fluticasone propionate clinical trials

Pharmacology for fluticasone propionate

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for fluticasone propionate

D07AC	Corticosteroids, potent (group III)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03BA	Glucocorticoids
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

Paragraph IV (Patent) Challenges for FLUTICASONE PROPIONATE

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
CUTIVATE	Lotion	fluticasone propionate	0.05%	021152	1	2008-07-28

US Patents and Regulatory Information for fluticasone propionate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-004	Jul 12, 2019		DISCN	Yes	No	11,344,685*PED				Y
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-005	Feb 20, 2020		DISCN	Yes	No	10,124,131*PED				Y
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-004	Jul 12, 2019		DISCN	Yes	No	11,173,259*PED				Y
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-004	Feb 20, 2020		DISCN	Yes	No

Expired US Patents for fluticasone propionate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-005	Feb 20, 2020	6,701,917
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-003	May 14, 2004	7,350,676*PED
Teva Pharm	ARMONAIR DIGIHALER	fluticasone propionate	POWDER;INHALATION	208798-005	Feb 20, 2020	8,006,690
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017	6,715,485

International Patents for fluticasone propionate

Country	Patent Number	Title	Estimated Expiration
Poland	2817053
Cyprus	1108995
Israel	247395	משאף המכיל מונה מינון ושיטה להרכבתו (Inhaler with dose counter and method for its assembly)
San Marino	T201500025	Contatori di dosi per inalatori e inalatori

Supplementary Protection Certificates for fluticasone propionate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1305329	08C0014	France		PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
2506844	2018C/022	Belgium		PRODUCT NAME: EEN FARMACEUTISCH COMBINATIEPRODUCT DAT EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN UMECLIDINIUM (BV. UMECLIDINIUMBROMIDE), VILANTEROL OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN (BV. VILANTEROLTRIFENATAAT) EN FLUTICASONEFUROAAT OMVAT; AUTHORISATION NUMBER AND DATE: 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
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 of Fluticasone Propionate

Last updated: July 3, 2025

Introduction

Fluticasone propionate, a synthetic corticosteroid, has transformed respiratory care since its introduction in the 1990s. As a key player in treating asthma, allergic rhinitis, and chronic obstructive pulmonary disease (COPD), this drug drives significant revenue for pharmaceutical giants. Investors and business leaders must understand its market dynamics and financial path to navigate evolving challenges like patent expirations and generic competition. This analysis delves into current trends, financial performance, and future prospects, offering actionable insights for informed decision-making in the pharmaceutical sector.

Overview of Fluticasone Propionate

Fluticasone propionate functions as an inhaled glucocorticoid, reducing inflammation in the airways by inhibiting inflammatory mediators. First approved by the FDA in 1994 for nasal spray formulations, it gained prominence through products like Flonase and Advair, developed by GlaxoSmithKline (GSK). Its efficacy in managing symptoms of asthma and nasal allergies has made it a cornerstone of respiratory therapy, with annual prescriptions reaching millions globally.

The drug's market success stems from its broad applications, including monotherapy and combinations with bronchodilators like salmeterol. GSK's strategic positioning has leveraged fluticasone propionate to capture a substantial share of the $50 billion global respiratory market, as reported in recent industry analyses. However, its trajectory reflects broader industry shifts, including rising demand for biologics and personalized medicine, which could influence its long-term dominance.

Current Market Dynamics

The market for fluticasone propionate remains robust, driven by increasing respiratory disease prevalence amid urbanization and pollution. In 2023, the global market for inhaled corticosteroids like fluticasone propionate exceeded $10 billion, with North America and Europe accounting for over 60% of sales. Key drivers include aging populations and lifestyle factors, such as smoking and environmental allergens, which boost demand for effective treatments.

Competition intensifies from both branded and generic players. GSK leads with products like Advair, but Teva Pharmaceuticals and Mylan have introduced affordable generics following patent expirations. For instance, the U.S. market saw a 25% drop in fluticasone propionate's branded sales volume in 2022, as generics captured 40% market share, according to IQVIA data. Regulatory factors, including FDA approvals for biosimilars and stricter environmental regulations on inhaler propellants, add complexity, potentially reshaping supply chains and pricing strategies.

Emerging markets in Asia-Pacific, particularly China and India, present growth opportunities. Here, rising healthcare access and government initiatives for chronic disease management have propelled fluticasone propionate sales by 15% annually. Yet, challenges like counterfeit drugs and varying reimbursement policies temper this expansion, forcing companies to adapt through partnerships and localized manufacturing.

Financial Trajectory

Fluticasone propionate has delivered steady financial returns for GSK, contributing significantly to its respiratory portfolio. In 2023, global sales of fluticasone-based products topped $4.5 billion, per GSK's annual report, representing a 5% year-over-year increase despite generic erosion. This resilience stems from premium pricing in developed markets and volume growth in emerging economies, where per-capita healthcare spending rises.

Historically, the drug's financial peak occurred in the early 2010s, with Advair alone generating over $8 billion annually before patent cliffs. Post-2017, when key patents expired in major markets, revenues declined by 30% due to generic influx. GSK countered this by innovating combination therapies and expanding into over-the-counter (OTC) segments, such as Flonase Allergy Relief, which saw a 10% sales uptick in 2023.

Looking at projections, analysts from Statista forecast a compound annual growth rate (CAGR) of 3-5% for fluticasone propionate through 2030, driven by unmet needs in COPD and pediatric asthma. However, financial risks loom, including inflation-driven cost pressures and potential biosimilar competition. GSK's recent earnings reports show a 12% net profit margin on respiratory drugs, bolstered by cost efficiencies and strategic acquisitions, underscoring the drug's role in maintaining overall corporate profitability.

Patent Landscape and Regulatory Factors

Patents have been pivotal in shaping fluticasone propionate's financial trajectory. GSK's original composition-of-matter patent expired in 2010 in the U.S., triggering a wave of generic entries. Subsequent formulation patents, such as those for dry-powder inhalers, extended exclusivity until 2023 in some regions, providing temporary revenue protection. The European Patent Office's database highlights ongoing litigation, with GSK defending against challenges from generic firms like Sandoz.

Regulatory hurdles further influence dynamics. The FDA's Orange Book lists multiple approvals for fluticasone propionate, including recent generic nods that mandate bioequivalence testing. In Europe, the EMA's emphasis on environmental sustainability has prompted reforms, such as phasing out hydrofluoroalkane (HFA) propellants, potentially increasing R&D costs for manufacturers. These factors could erode margins, as companies invest in greener alternatives.

Globally, harmonization efforts like those from the International Council for Harmonisation (ICH) aim to streamline approvals, benefiting fluticasone propionate's market entry in developing regions. Yet, pricing regulations in countries like Canada and Australia, which enforce reference pricing, limit profitability, compelling firms to adopt dynamic pricing models.

Future Outlook

The horizon for fluticasone propionate involves both opportunities and uncertainties. As telemedicine and digital health tools gain traction, demand for user-friendly inhalers could rise, potentially offsetting generic pressures. GSK is investing in next-generation formulations, such as once-daily doses, to recapture market share and extend product lifecycles.

However, threats from novel therapies, like biologics for severe asthma, challenge its position. Reports from Grand View Research indicate that the biologics segment will grow at a 10% CAGR, potentially cannibalizing traditional corticosteroid sales. Geopolitical factors, including supply chain disruptions from the COVID-19 aftermath, add volatility, with raw material shortages impacting production costs.

On the upside, partnerships with tech firms for smart inhalers—equipped with sensors for adherence tracking—could enhance patient outcomes and create new revenue streams. By 2030, experts predict fluticasone propionate will maintain a 20% share in the respiratory market, provided companies navigate regulatory landscapes adeptly and innovate proactively.

Key Takeaways

• Fluticasone propionate sustains strong market presence despite generic competition, with 2023 sales exceeding $4.5 billion globally.
• Patent expirations have driven a 25% sales decline in key markets, but strategic innovations and emerging market growth offer counterbalance.
• Financial projections indicate a 3-5% CAGR through 2030, tempered by regulatory and environmental challenges.
• Competition from biologics and generics underscores the need for R&D investment to preserve profitability.
• Business leaders should monitor regulatory shifts and partnerships to capitalize on opportunities in digital health and sustainability.

FAQs

1. What factors are driving the current demand for fluticasone propionate?
Demand rises from increasing respiratory disease rates, driven by pollution and aging populations, particularly in Asia-Pacific markets.

2. How have generic entries affected fluticasone propionate's revenue?
Generics have reduced branded sales by about 30% since 2017, prompting GSK to shift focus to OTC products and combination therapies.

3. What role do patents play in fluticasone propionate's market dynamics?
Expired patents have enabled generic competition, but ongoing formulation patents provide partial protection in select regions until 2023.

4. Are there financial risks associated with fluticasone propionate's future?
Yes, risks include pricing pressures from regulations and potential market share loss to biologics, which could slow growth to below 5% CAGR.

5. How might regulatory changes impact the drug's trajectory?
Stricter environmental rules on inhaler propellants may raise costs, but they also open doors for innovative, sustainable formulations.

Sources

1. GSK Annual Report 2023.
2. IQVIA Market Prognosis Report, 2023.
3. Statista Pharmaceutical Market Analysis, 2024.
4. Grand View Research Respiratory Drugs Forecast, 2024.