FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - Generic Drug Details

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

Fluticasone propionate; salmeterol xinafoate is the generic ingredient in eight branded drugs marketed by Glaxo Grp Ltd, Teva Pharm, Hikma, Teva Pharms Usa, and Mylan, and is included in six NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fluticasone propionate; salmeterol xinafoate has two hundred and forty-eight patent family members in thirty-seven countries.

Eleven suppliers are listed for this compound.

Summary for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

International Patents:	248
US Patents:	9
Tradenames:	8
Applicants:	5
NDAs:	6
Finished Product Suppliers / Packagers:	11
Clinical Trials:	43
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
DailyMed Link:	FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE at DailyMed

Recent Clinical Trials for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

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

Sponsor	Phase
Novartis Pharmaceuticals	Phase 3
Imperial College London	Phase 4
European Research Council	Phase 4

See all FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE clinical trials

Pharmacology for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Drug Class	Corticosteroid beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

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

R03AC	Selective beta-2-adrenoreceptor agonists
R03A	ADRENERGICS, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

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

US Patents and Regulatory Information for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	WIXELA INHUB	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208891-002	Jan 30, 2019	AB	RX	No	No
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-004	Jul 12, 2019		DISCN	Yes	No	10,195,375*PED				Y
Teva Pharms Usa	FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	213948-002	Dec 13, 2021	AB	RX	No	No
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-004	Jul 12, 2019		DISCN	Yes	No	10,918,816*PED				Y
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-005	Jul 12, 2019		DISCN	Yes	No	11,969,544*PED				Y
Teva Pharm	AIRDUO DIGIHALER	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-004	Jul 12, 2019		DISCN	Yes	No	9,987,229*PED				Y

Expired US Patents for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	ADVAIR HFA	fluticasone propionate; salmeterol xinafoate	AEROSOL, METERED;INHALATION	021254-003	Jun 8, 2006	6,997,349*PED
Glaxo Grp Ltd	ADVAIR DISKUS 100/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-001	Aug 24, 2000	7,389,775*PED
Glaxo Grp Ltd	ADVAIR DISKUS 500/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-003	Aug 24, 2000	7,389,775*PED
Glaxo Grp Ltd	ADVAIR HFA	fluticasone propionate; salmeterol xinafoate	AEROSOL, METERED;INHALATION	021254-002	Jun 8, 2006	6,546,928*PED
Glaxo Grp Ltd	ADVAIR HFA	fluticasone propionate; salmeterol xinafoate	AEROSOL, METERED;INHALATION	021254-001	Jun 8, 2006	7,143,908*PED
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-003	Jan 27, 2017	6,446,627

EU/EMA Drug Approvals for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Teva B.V.	Airexar Spiromax	salmeterol xinafoate, fluticasone propionate	EMEA/H/C/004267Airexar Spiromax is indicated for use in adults aged 18 years and older only.AsthmaAirexar Spiromax is indicated for the regular treatment of patients with severe asthma where use of a combination product (inhaled corticosteroid and long-acting β2 agonist) is appropriate:- patients not adequately controlled on a lower strength corticosteroid combination productor- patients already controlled on a high dose inhaled corticosteroid and long-acting β2 agonist.Chronic Obstructive Pulmonary Disease (COPD)Airexar Spiromax is indicated for the symptomatic treatment of patients with COPD, with a FEV1	Withdrawn	no	no	no	2016-08-18

International Patents for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Country	Patent Number	Title	Estimated Expiration
China	107530357	包含丙酸氟替卡松和昔萘酸沙美特罗的干粉吸入器 (Dry powder inhaler comprising fluticasone propionate and salmeterol xinafoat)
Poland	2496294
New Zealand	618744
Slovenia	1699434
Spain	2860049
South Korea	102364945

Supplementary Protection Certificates for FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

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
1305329	08C0014	France		PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
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	132013902182575	Italy		PRODUCT NAME: AZELASTINA CLORIDRATO/FLUTICASONE PROPIONATO(DYMISTA); AUTHORISATION NUMBER(S) AND DATE(S): 2011/07125-REG, 20111024;041808015/M-027/M-039/M-041/M, 20130527
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
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

Market Dynamics and Financial Trajectory for Fluticasone Propionate; Salmeterol Xinafoate

Last updated: July 28, 2025

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Introduction

The combination therapy of fluticasone propionate and salmeterol xinafoate represents a cornerstone in the management of asthma and chronic obstructive pulmonary disease (COPD). With evolving market dynamics and a robust pipeline of innovations, understanding the economic landscape of this therapeutic duo is vital for stakeholders ranging from pharmaceutical companies to investors. This article examines the current market conditions, competitive landscape, growth drivers, challenges, and future projections for this drug combination.

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Market Overview

Fluticasone propionate is a potent inhaled corticosteroid (ICS), while salmeterol xinafoate is a long-acting beta-agonist (LABA). Their combined formulation offers synergistic relief for airway inflammation and bronchospasm, making it a preferred therapy for asthma and COPD. The global market for inhaled corticosteroids and LABAs is expected to grow significantly, driven by increasing prevalence of respiratory diseases and advances in inhaler technology.

According to QY Research, the global respiratory drug market, which includes ICS and LABA treatments, is projected to reach approximately USD 30 billion by 2027, with a compound annual growth rate (CAGR) of roughly 7%. The demand for combination inhalers like fluticasone propionate and salmeterol xinafoate constitutes a sizable share of this expansion, driven by their proven efficacy and patient adherence advantages.

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Market Drivers

Rising Prevalence of Respiratory Diseases

The World Health Organization (WHO) reports that asthma affects approximately 262 million people worldwide, while COPD accounts for over 3 million deaths annually. Urbanization, pollution, and smoking escalate disease incidence. The escalating patient pool directly correlates with increased demand for effective controller medications like fluticasone-salmeterol combinations.

Increased Awareness and Diagnosis

Enhanced diagnostic capabilities and patient education campaigns expand the diagnosed population, further elevating market demand. Regulatory advancements promoting early intervention policies also contribute positively.

Product Approvals and Patent Expirations

Major pharmaceutical companies continue to innovate with new formulations, delivering once-daily dosing and improved delivery mechanisms, boosting sales. Legacy products nearing patent expiry face generic competition, influencing market share dynamics and pricing strategies.

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Competitive Landscape

The leading market players include GlaxoSmithKline (GSK), AstraZeneca, Teva Pharmaceutical Industries, and Mylan. GSK's Advair (known as Seretide outside the US) remains a dominant product, accounting for a significant market share due to its long-standing presence and extensive distribution network.

Generic Entrants: Post-patent expiry, generic formulations are entering markets, exerting downward pressure on prices and revenue streams. However, brand-loyalty, inhaler device preferences, and regulatory hurdles sustain brand dominance for key players initially.

Innovative Formulations: Enhanced delivery systems, including dry powder inhalers (DPIs) with improved dose stabilization, are differentiating products in an increasingly commoditized landscape.

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Market Challenges

Patent Cliff

Expiration of key patents, notably for Advair in multiple jurisdictions over the past several years, has led to revenue erosion for originators as generics gain market traction.

Pricing Pressures and Reimbursement Policies

Government-led price controls, especially in cost-sensitive markets like India and parts of Europe, constrict profit margins. Payor push for value-based formulary decisions favors lower-cost generics and biosimilars.

Regulatory Hurdles

Stringent regulatory pathways for approvals, especially for combination therapies, prolong time-to-market for new entrants and innovations. Concerns about inhalation device safety and efficacy further complicate regulatory processes.

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Financial Trajectory and Growth Outlook

Historical Financial Performance

GSK's Advair franchise historically generated annual revenues exceeding USD 5 billion globally. Post-patent expiry, sales declined by approximately 30% in the US alone over recent years. However, GSK has diversified its respiratory portfolio, focusing on inhaler devices and novel combination therapies.

Projected Revenue Growth

The market for inhaled corticosteroid-LABA combinations is forecasted to grow at a CAGR of 6-8% through 2030. Factors such as rising prevalence, improved formulations, and expanding geographic coverage underpin this outlook.

Analysts expect disease-specific growth, particularly in emerging markets, where increasing urbanization drives respiratory disease burden. Major markets like China, India, and Brazil are projected to contribute significantly, driven by healthcare infrastructure improvements and increased access.

Emerging Markets

Rapidly growing healthcare expenditure and increasing awareness position emerging markets as lucrative expansion zones. Local manufacturing alliances and strategic partnerships are facilitating drug accessibility.

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Technological and Regulatory Trends

Innovations: The development of once-daily inhalers, smart inhalers with digital tracking, and combination formulations with added benefits (e.g., anti-inflammatory and bronchodilator effects in a single device) are redefining market competitiveness.

Regulation: Stringent adherence to regulatory standards by agencies such as the FDA and EMA accelerates approval timelines for novel formulations, with an emphasis on safety, efficacy, and inhaler device performance.

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Future Outlook and Strategic Considerations

The market trajectory for fluticasone propionate and salmeterol xinafoate will hinge on several factors:

• Pipeline Innovations: Development of triple inhalers combining an ICS, LABA, and a long-acting muscarinic antagonist (LAMA) promises to further streamline therapy, potentially disrupting current market shares.

• Biosimilars and Generics: Market entrants offering bioequivalent formulations at lower prices could compress margins for established brands, emphasizing the importance of innovation and patent protection strategies.

• Patient-Centric Solutions: Digital inhalers, adherence support programs, and personalized medicine approaches will enhance market uptake and brand loyalty.

• Regulatory Environment: Evolving policies emphasizing affordable access will necessitate strategic adjustments, especially in cost-sensitive regions.

Financial projections indicate that, despite competitive pressures, the total market for combination inhalers will witness steady growth, with revenues potentially surpassing USD 25 billion by 2030 globally.

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Key Takeaways

• The respiratory drug market, led by ICS/LABA combinations like fluticasone propionate and salmeterol xinafoate, is expanding steadily due to increasing disease prevalence and technological advancements.

• Patent expiration, alongside the rise of generics and biosimilars, creates pricing pressures but also spurs innovation.

• Emerging markets represent significant growth opportunities, provided companies adapt to local regulatory and economic conditions.

• Innovation in inhaler devices and digital health integration are critical differentiation strategies.

• Strategic partnerships, pipeline diversification, and investment in patient-centric solutions will shape future market leadership.

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FAQs

1. How does patent expiration affect the market for fluticasone-salmeterol combinations?
Patent expiration leads to the entry of generic competitors, which typically results in significant price reductions and revenue declines for originator brands. However, brand loyalty, patent extensions, and formulation improvements can mitigate some effects.

2. What are the main drivers for growth in the inhaled corticosteroid-LABA market?
Key drivers include rising respiratory disease prevalence, technological innovations in inhaler delivery systems, expanding healthcare access in emerging markets, and increasing adoption of combination therapies for better disease management.

3. How are biosimilars impacting the market?
While biosimilars are more common in biologic therapies, the emergence of generic inhalers for fluticasone and salmeterol is expected to put downward pressure on prices. This scenario encourages companies to innovate and differentiate their offerings.

4. What role does digital health play in the future of inhaled therapies?
Digital inhalers with tracking capabilities improve adherence, provide real-time data for physicians, and enhance patient engagement—all of which foster better disease control and market competitiveness.

5. What are the regulatory challenges facing new formulations of fluticasone and salmeterol?
Regulatory agencies require comprehensive data on safety, efficacy, and device performance. Demonstrating bioequivalence, ensuring consistent dose delivery, and meeting stricter quality standards can prolong approval timelines.

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References

1. [1] QY Research. (2022). Global Respiratory Drug Market Outlook.
2. [2] World Health Organization. (2021). Global Surveillance, Prevention and Control of Chronic Respiratory Diseases.
3. [3] GSK Annual Report. (2021).
4. [4] Frost & Sullivan. (2022). Trends in Inhaler Device Technologies.
5. [5] U.S. Food and Drug Administration. (2022). Regulatory Pathways for Inhalation Products.

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This comprehensive analysis offers a strategic perspective into the market forces shaping the future of fluticasone propionate and salmeterol xinafoate therapies.