ADVAIR DISKUS 500/50 Drug Patent Profile

When do Advair Diskus 500/50 patents expire, and what generic alternatives are available?

Advair Diskus 500/50 is a drug marketed by Glaxo Grp Ltd and is included in one NDA.

The generic ingredient in ADVAIR DISKUS 500/50 is fluticasone propionate; salmeterol xinafoate. There are twenty-nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the fluticasone propionate; salmeterol xinafoate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Advair Diskus 500/50

A generic version of ADVAIR DISKUS 500/50 was approved as fluticasone propionate; salmeterol xinafoate by HIKMA on December 17^th, 2020.

Summary for ADVAIR DISKUS 500/50

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	7
Clinical Trials:	59
DailyMed Link:	ADVAIR DISKUS 500/50 at DailyMed

Recent Clinical Trials for ADVAIR DISKUS 500/50

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

Sponsor	Phase
Becro Ltd.	Phase 3
Teva Pharmaceuticals USA	Phase 3
Respirent Pharmaceuticals Co Ltd.	Phase 1

See all ADVAIR DISKUS 500/50 clinical trials

Pharmacology for ADVAIR DISKUS 500/50

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

US Patents and Regulatory Information for ADVAIR DISKUS 500/50

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	ADVAIR DISKUS 500/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-003	Aug 24, 2000	AB	RX	Yes	Yes

Expired US Patents for ADVAIR DISKUS 500/50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	ADVAIR DISKUS 500/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-003	Aug 24, 2000	6,032,666*PED
Glaxo Grp Ltd	ADVAIR DISKUS 500/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-003	Aug 24, 2000	7,225,808*PED
Glaxo Grp Ltd	ADVAIR DISKUS 500/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-003	Aug 24, 2000	5,270,305*PED

EU/EMA Drug Approvals for ADVAIR DISKUS 500/50

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 ADVAIR DISKUS 500/50

See the table below for patents covering ADVAIR DISKUS 500/50 around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	9202717	CARBOTIOATOS DE ANDROSTANO Y COMPOSICIONES FARMACEUTICAS QUE LOS CONTIENEN.
Canada	2024789	COMPOSES POUR LE TRAITEMENT DES INFLAMMATIONS ET DES ALLERGIES (COMPOUNDS FOR THE TREATMENT OF INFLAMMATION AND ALLERGY)
New Zealand	221999	PHENYLALKOXY DERIVATIVES

Supplementary Protection Certificates for ADVAIR DISKUS 500/50

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
0416951	C990012	Netherlands		PRODUCT NAME: SALMETEROL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN FLUTICASONPROPIONAAT,IN HET BIJZONDER SALMETEROLXINAFOAAT EN FLUTICASONPROPIONAAT; NATL REGISTRATION NO/DATE: RVG 23529 - RVG 23534 19990112; FIRST REGISTRATION: SE 14591 - 14596 19980907

Market Dynamics and Financial Trajectory for ADVAIR DISKUS 500/50

Last updated: October 13, 2025

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Introduction

ADVAIR DISKUS 500/50, a combination inhaler comprising fluticasone propionate and salmeterol xinafoate, is a prominent therapeutic option in the management of asthma and COPD (Chronic Obstructive Pulmonary Disease). Developed by GlaxoSmithKline (GSK), its market positioning hinges on efficacy, safety profile, and evolving regulatory and competitive dynamics. This analysis explores the current market landscape, growth drivers, challenges, and future financial trajectory of ADVAIR DISKUS, vital for stakeholders and industry strategists.

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Market Overview and Dynamics

Global Respiratory Disease Burden

The increasing prevalence of asthma and COPD, fueled by aging populations, air pollution, and lifestyle factors, sustains demand for inhaled therapies. The WHO estimates over 262 million cases of COPD globally, with annual deaths exceeding 3 million [1]. Asthma affects approximately 262 million, emphasizing persistent unmet needs for effective, long-term control solutions.

Product Positioning and Market Share

ADVAIR DISKUS has cemented itself as a top-tier LABA/ICS combination inhaler, with a notable presence in North America, Europe, and emerging markets. Its dual mechanism addresses both bronchoconstriction and inflammation—key pathophysiological components. According to IQVIA data, GSK's respiratory portfolio holds a significant portion of the inhaler market, with ADVAIR representing a substantial revenue contributor.

Competitive Landscape

ADVAIR's primary competitors include:

• Symbicort (Boehringer Ingelheim and AstraZeneca): Another ICS/LABA combination.
• Dulera (AstraZeneca): For asthma.
• Fluticasone/Salmeterol (generic versions): Increasingly commoditized.

Emerging therapies, such as biologics targeting eosinophilic inflammation (e.g., Nucala, Dupixent), are reshaping treatment paradigms, especially in severe asthma. However, inhaled corticosteroids and LABAs remain first-line therapies, underpinning ADVAIR's sustained relevance.

Regulatory and Reimbursement Trends

Regulatory scrutiny on inhaler safety, particularly concerning side effects like pneumonia risk associated with ICS, influences prescribing patterns. Reimbursement policies and formulary placements further impact sales—favorable coverage in major markets supports stable revenue streams.

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Market Drivers Influencing Financial Trajectory

Growing Prevalence of Respiratory Diseases

The persistent rise in asthma and COPD cases forecasts sustained demand. Aging populations in developed nations and urbanization in emerging markets will amplify this trend.

Innovations and Formulation Improvements

GSK's ongoing investment in delivering enhanced inhaler devices (e.g., improved dose delivery, compliance features) boosts patient adherence, translating into higher sales. The development of fixed-dose combination inhalers that facilitate combination therapies is also notable.

Expanding Market Access

Strategic partnerships and localized manufacturing in emerging economies expand market access. GSK’s tailored pricing strategies in low- and middle-income countries (LMICs) help penetrate markets with rising disease burden but limited healthcare infrastructure.

Pipeline and Label Expansion

Though ADVAIR DISKUS's patent exclusivity has faced challenges, GSK’s pursuit of labeling extensions (e.g., for severe asthma, COPD indications) can prolong revenue streams. Concurrently, biosimilar entries may challenge pricing power but also spur competition, potentially leading to price adjustments and increased volume sales.

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Challenges and Risks

Patent Expirations and Biosimilar Competition

Patent expiry often precipitates revenue erosion. The introduction of generic and biosimilar competitors can significantly impact pricing strategies and market share. Notably, GSK faced patent challenges with ADVAIR’s formulations in some jurisdictions.

Safety Concerns and Regulatory Restrictions

Widespread recognition of pneumonia risks with ICS use necessitates careful patient selection and can influence clinician prescribing behavior, thereby impacting sales.

Pricing Pressures and Reimbursement Policies

Stricter pricing regulations, especially in Europe and the US, pressure margins. Payer demands for cost-effective therapies challenge premium-priced inhalers.

Market Saturation and Treatment Guidelines

Standardization of inhaler therapy according to evolving clinical guidelines may affect incremental sales growth once markets mature.

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Financial Trajectory and Future Outlook

Historical Performance & Revenue Trends

GSK’s respiratory franchise, including ADVAIR DISKUS, historically generated robust revenues. For FY2022, GSK reported respiratory sales of approximately GBP 4.2 billion, with ADVAIR constituting a sizable portion [2].

Projection for 2023–2028

Given the persistent disease burden and evolving market dynamics, ADVAIR’s revenues are projected to stay relatively stable with modest growth, contingent on several factors:

• Continued Access in Emerging Markets: As healthcare infrastructure improves, volume-driven growth is expected.
• Label and Indication Expansions: Potential extensions for specific patient cohorts could unlock additional revenue channels.
• Impact of Biosimilars and Generics: Anticipated biosimilar entries in certain geographies could pressure pricing but may be offset by increased volumes.

Analysts posit a compounded annual growth rate (CAGR) of approximately 1.5%–3% over the next five years, primarily driven by volume expansion rather than price increases, given market saturation and pricing pressures.

Strategic Initiatives and R&D

GSK's pipeline investments in novel inhalers and biologics for severe asthma aim to capture new market segments, potentially affecting ADVAIR’s market share proportionally. In the meantime, lifecycle management initiatives for existing formulations are expected to maintain competitiveness.

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Conclusion

ADVAIR DISKUS 500/50's market trajectory is characterized by sustained demand driven by global respiratory disease prevalence, clinical efficacy, and established prescriber confidence. While patent protections and innovative therapies present headwinds, strategic positioning through formulation improvements, geographical expansion, and indications optimization bolster revenue prospects. Overall, the product's financial outlook remains cautiously optimistic, reflecting both inherent market stability and external competitive pressures.

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Key Takeaways

• Stable Demand: The global burden of asthma and COPD ensures steady demand for ADVAIR DISKUS, especially in aging populations.
• Competitive Landscape: Intense competition from other combination inhalers and biologics necessitates continuous innovation and market differentiation.
• Patent and Biosimilar Risks: Expirations and biosimilar threats will likely temper revenue growth; strategic lifecycle management is crucial.
• Emerging Market Growth: Expansion in LMICs offers potential volume uplift, supported by localized manufacturing and reimbursement strategies.
• Regulatory Environment: Evolving safety profiles and reimbursement policies require ongoing engagement with regulatory authorities to sustain market access.

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FAQs

1. What are the primary factors influencing the sales of ADVAIR DISKUS?
   The main drivers include the rising prevalence of respiratory diseases, competitive dynamics, regulatory safety concerns, patent status, and market access in emerging economies.

2. How does biosimilar competition impact ADVAIR DISKUS?
   Biosimilars and generic versions can erode market share and reduce pricing power, although they may increase overall market volume and patient access.

3. What role do regulatory safety concerns play in ADVAIR's future?
   Warnings about pneumonia risks associated with ICS can influence prescribing patterns, prompting a need for clear patient selection and risk mitigation strategies.

4. Is there potential for expanding ADVAIR's indications?
   Yes. Label extensions for specific patient subgroups or new formulations could provide additional revenue streams, though regulatory approval is required.

5. What is the outlook for ADVAIR DISKUS over the next five years?
   Expect modest growth driven by volume increase and market expansion, with potential headwinds from biosimilar competition and regulatory pressures.

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References

[1] World Health Organization. (2021). Chronic obstructive pulmonary disease (COPD).
[2] GSK Annual Report 2022.