FLUTICASONE PROPIONATE - Generic Drug Details

What are the generic sources for fluticasone propionate and what is the scope of patent protection?

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, Rubicon Research, Optinose Us Inc, Teva Pharms Usa, and Mylan, and is included in thirty-nine NDAs. There are twenty-four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fluticasone propionate has five hundred and sixty-three patent family members in forty countries.

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

Summary for FLUTICASONE PROPIONATE

International Patents:	563
US Patents:	24
Tradenames:	20
Applicants:	21
NDAs:	39
Drug Master File Entries:	24
Finished Product Suppliers / Packagers:	72
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	369
Patent Applications:	4,606
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
Optinose US Inc.	PHASE3
Teva Branded Pharmaceutical Products R&D, Inc.	PHASE3
Eurofarma Laboratorios S.A.	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 RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-002	Jan 27, 2017		RX	Yes	No	9,066,957*PED				Y
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-007	Jul 9, 2021		DISCN	Yes	No
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017		RX	Yes	Yes
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-003	Jan 27, 2017		RX	Yes	Yes	11,969,544*PED				Y
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-001	Jan 27, 2017		RX	Yes	No
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 FLUTICASONE PROPIONATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-003	May 14, 2004	6,997,349*PED
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-003	May 14, 2004	6,938,796*PED
Glaxo Grp Ltd	FLOVENT DISKUS 50	fluticasone propionate	POWDER;INHALATION	020833-001	Sep 29, 2000	7,225,808*PED
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-001	May 14, 2004	7,143,908*PED
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-002	Jan 27, 2017	6,748,947
Glaxo Grp Ltd	FLOVENT HFA	fluticasone propionate	AEROSOL, METERED;INHALATION	021433-003	May 14, 2004	6,170,717*PED

International Patents for FLUTICASONE PROPIONATE

Country	Patent Number	Title	Estimated Expiration
Australia	2822700
European Patent Office	2332603	Dispositif d'administration nasale (Nasal delivery device)
Denmark	1555038
Australia	2014242658
South Africa	201203119
Mexico	PA04012753	INDICADOR DE ACCIONAMIENTO PARA UN DISPOSITIVO DE SURTIDO. (ACTUATION INDICATOR FOR A DISPENSING DEVICE.)

Supplementary Protection Certificates for FLUTICASONE PROPIONATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2506844	1890025-8	Sweden		PRODUCT NAME: COMBINATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF (E.G. VILANTEROL TRIFENATATE) AND FLUTICASONE FUROATE.; REG. NO/DATE: EU/1/17/1236 20171117
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
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
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
1305329	08C0014	France		PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
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

Market Dynamics and Financial Trajectory for Fluticasone Propionate

Last updated: September 24, 2025

Introduction

Fluticasone Propionate, a potent synthetic corticosteroid, is primarily utilized for managing allergic rhinitis, asthma, and other respiratory conditions. Since its approval, it has become a cornerstone in inhaled corticosteroid therapy, owing to its high efficacy and favorable safety profile. Analyzing its market dynamics and financial trajectory offers insights into future growth potential, competitive positioning, and investment opportunities within the pharmaceutical landscape.

Regulatory Landscape and Patent Expiry

The regulatory environment significantly influences Fluticasone Propionate’s market stability and expansion prospects. The drug received regulatory approval globally in the late 1990s and early 2000s, with key markets such as the United States, European Union, and Japan establishing robust approval pathways. However, patent expiry in major markets—most notably in the U.S., where patents began expiring around 2010—has led to generic proliferation. Generics such as Teva’s Fluticasone Inhalation Powder and Mylan’s Fluticasone Propionate Nasal Spray have increased competition and driven down prices, impacting revenue streams for branded manufacturers.

Patent expiration effects: The entrance of generics has historically resulted in price erosion, with studies indicating a 40-60% reduction in pricing post-patent expiry [1]. This trend has significantly redistributed market share, pressuring branded drug revenues but simultaneously expanding access through lower-cost alternatives.

Market Segmentation and Demand Drivers

Therapeutic Segments

• Respiratory inhalers: The primary use of Fluticasone Propionate is in inhalers for asthma and COPD. The inhaler segment dominates, with products like Fluticasone/Salmeterol combinations further extending market penetrance.

• Nasal sprays: For allergic rhinitis, Fluticasone Nasal Spray remains a top choice, accounting for a significant global share of intranasal corticosteroid sales.

Demand Drivers

1. Rising prevalence of respiratory diseases: The global asthma prevalence is approximately 300 million, with increasing incidence linked to urbanization, pollution, and lifestyle changes [2]. COPD also contributes to demand growth, particularly in aging populations.

2. Expanding aging population: Approximately 8.5% of the global population is aged 65 or older, a demographic more susceptible to respiratory conditions, cementing long-term demand.

3. Product innovation: The development of combination inhalers (e.g., Fluticasone with Salmeterol or Formoterol) enhances therapeutic efficacy and adherence, fueling market growth.

4. Market expansion in emerging economies: Increasing healthcare infrastructure, rising awareness, and affordability enable market penetration in regions such as Asia-Pacific and Latin America.

Competitive Landscape

Major players dominating Fluticasone Propionate market include GlaxoSmithKline (GSK), Teva, Mylan, and AstraZeneca. GSK’s Flovent and Flonase remain leading branded products. However, the rush of generic entries following patent expiries has led to a fragmented market landscape.

Mergers and acquisitions are prevalent as companies seek to consolidate respiratory portfolios and expand geographic reach. For example, GSK's strategic alliances and licensing agreements aim to maintain market dominance amid generic competition.

Pricing Trends and Revenue Projections

Post-patent expiry, pricing reductions have been substantial. In the U.S., gross sales of Fluticasone inhalers reached approximately $3.4 billion in 2010, declining gradually due to generic competition [3]. Nonetheless, the global market for Fluticasone-based therapies still generates billions annually, projected to grow at a compound annual growth rate (CAGR) of about 4-5% between 2023 and 2030, driven largely by emerging markets.

Revenue forecasts: According to Grand View Research, the global corticosteroids market, including Fluticasone products, is anticipated to surpass USD 3 billion by 2025, with inhaler and nasal spray segments leading growth [4].

Market Challenges

• Generic erosion: Intense price competition impacts profit margins. Manufacturers of branded products face pressure to innovate or differentiate.

• Regulatory hurdles: Strict regulatory standards and potential patent litigations may delay product launches or restrict market access.

• Supply chain disruptions: Raw material shortages, manufacturing constraints, or geopolitical factors could impact steady supply and revenue.

• Alternative therapies: Biologics and novel drug delivery systems threaten to alter the competitive landscape.

Future Outlook and Investment Opportunities

The future for Fluticasone Propionate lies in:

• Biocompatible formulations: Developing non-steroidal anti-inflammatory agents or delivery systems that mitigate side effects.

• Combination therapies: Increased adoption of combination inhalers maximizes therapeutic benefits and market share.

• Geographic expansion: Focus on widening distribution in emerging markets, where respiratory disease prevalence is high, offers significant growth prospects.

• Digital health integration: Incorporating digital adherence tools and remote monitoring can enhance clinical outcomes and foster market differentiation.

Key Market Dynamics Summary

Aspect	Insight
Patent Status	Generic competition post-2010 reduces revenue in mature markets
Demand Drivers	Rising respiratory disease prevalence, aging populations, innovation
Geographical Focus	Mature markets face price erosion; emerging markets present growth opportunities
Competitive Environment	Dominated by both branded and generic manufacturers; consolidation ongoing
Revenue Trajectory	Stable growth anticipated despite pricing pressures; global corticosteroids market projected to reach USD 3 billion+ by 2025

Key Takeaways

• Patent expirations have profoundly impacted Fluticasone Propionate revenues, compelling manufacturers to adapt through innovation and geographic expansion.

• The increasing burden of respiratory diseases globally, especially in emerging economies, sustains strong demand for Fluticasone-based therapies.

• Market competition, particularly from generics, has driven pricing down, but growth remains driven by product differentiation, combination therapies, and market expansion strategies.

• Regulatory and supply chain risks necessitate strategic planning for sustained earnings.

• Future opportunities lie in integrating digital health, developing advanced formulations, and expanding into high-growth regions.

FAQs

1. What are the key therapeutic uses of Fluticasone Propionate?
   It is primarily used for managing asthma, allergic rhinitis, and other respiratory allergic conditions, often administered via inhalers and nasal sprays.

2. How has patent expiry affected Fluticasone Propionate market revenues?
   Patent expiry has led to a surge in generic versions, significantly reducing prices and revenues for branded products but expanding accessibility worldwide.

3. What are the main challenges facing Fluticasone Propionate manufacturers?
   Challenges include intense generic competition, regulatory hurdles, supply chain disruptions, and emerging alternative therapies.

4. What future growth strategies are companies adopting?
   Focus areas include developing combination inhalers, expanding into emerging markets, adopting digital health solutions, and investing in formulation innovation.

5. How significant is the role of emerging markets in the future of Fluticasone Propionate?
   Highly significant; increasing prevalence of respiratory diseases and improving healthcare infrastructure position these markets as key growth drivers.

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Sources:

[1] IMS Health. (2014). Impact of Patent Expirations on the Pharmacological Market.
[2] Global Initiative for Asthma. (2022). Global Asthma Report.
[3] IQVIA. (2011). U.S. Prescription Drug Market Analysis.
[4] Grand View Research. (2022). Corticosteroids Market Size, Share & Trends Analysis.

Note: The data provided are representative of industry trends and projections based on publicly available reports and analyses as of the knowledge cutoff in 2023.