ADVAIR DISKUS 100/50 Drug Patent Profile

When do Advair Diskus 100/50 patents expire, and when can generic versions of Advair Diskus 100/50 launch?

Advair Diskus 100/50 is a drug marketed by Glaxo Grp Ltd and is included in one NDA.

The generic ingredient in ADVAIR DISKUS 100/50 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 100/50

A generic version of ADVAIR DISKUS 100/50 was approved as fluticasone propionate; salmeterol xinafoate by HIKMA on December 17^th, 2020.

Summary for ADVAIR DISKUS 100/50

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 100/50 at DailyMed

Recent Clinical Trials for ADVAIR DISKUS 100/50

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

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

See all ADVAIR DISKUS 100/50 clinical trials

Pharmacology for ADVAIR DISKUS 100/50

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

US Patents and Regulatory Information for ADVAIR DISKUS 100/50

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 100/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-001	Aug 24, 2000	AB	RX	Yes	Yes

Expired US Patents for ADVAIR DISKUS 100/50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	ADVAIR DISKUS 100/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-001	Aug 24, 2000
Glaxo Grp Ltd	ADVAIR DISKUS 100/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-001	Aug 24, 2000
Glaxo Grp Ltd	ADVAIR DISKUS 100/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-001	Aug 24, 2000
Glaxo Grp Ltd	ADVAIR DISKUS 100/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-001	Aug 24, 2000
Glaxo Grp Ltd	ADVAIR DISKUS 100/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-001	Aug 24, 2000
Glaxo Grp Ltd	ADVAIR DISKUS 100/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-001	Aug 24, 2000

EU/EMA Drug Approvals for ADVAIR DISKUS 100/50

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 100/50

See the table below for patents covering ADVAIR DISKUS 100/50 around the world.

Country	Patent Number	Title	Estimated Expiration
Sweden	9100582
Singapore	12289
United Kingdom	2274273	Medicament pack
Canada	2024789	COMPOSES POUR LE TRAITEMENT DES INFLAMMATIONS ET DES ALLERGIES (COMPOUNDS FOR THE TREATMENT OF INFLAMMATION AND ALLERGY)
Germany	3105307
Finland	107883

Supplementary Protection Certificates for ADVAIR DISKUS 100/50

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	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	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
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
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

Market Dynamics and Financial Trajectory for ADVAIR DISKUS 100/50

Last updated: November 17, 2025

Introduction

ADVAIR DISKUS 100/50, a combination inhaler comprising fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg), plays a vital role in managing asthma and chronic obstructive pulmonary disease (COPD). Its market position is shaped by evolving healthcare landscapes, regulatory frameworks, and competitive pressures. This analysis evaluates the current market dynamics and forecasts the financial trajectory for ADVAIR DISKUS 100/50, providing actionable insights for stakeholders.

Market Overview

ADVAIR DISKUS operates within the broader respiratory therapeutics segment, which has experienced significant growth driven by increasing prevalence of asthma and COPD globally. The inhalation therapy market was valued at approximately USD 27 billion in 2021 and is projected to grow at a CAGR of 5.5% through 2026 [1].

Epidemiological Drivers

• Rising Prevalence of Respiratory Diseases: According to WHO, over 300 million people suffer from asthma worldwide, with COPD affecting approximately 300 million globally [2]. Factors such as air pollution, smoking, and urbanization contribute to these trends.
• Aging Populations: The global demographic shift toward older age groups heightens demand for medications addressing chronic respiratory conditions.

Medical and Regulatory Trends

• Inhaler Guidelines: Increasing adherence to global guidelines (e.g., GINA and GOLD) favor combination therapies like ADVAIR, which are recommended for moderate to severe asthma and COPD cases.
• Regulatory Approvals: FDA and EMA approvals, including label updates for once-daily dosing and combination use, bolster market acceptance.

Competitive Landscape

ADVAIR faces competition primarily from:

• Generic formulations: As patent protections expire, generics pose a threat.
• Other combination inhalers: Spiriva (tiotropium), Symbicort (budesonide/formoterol), and Advair's own generics impact market share.
• Emerging therapies: Biologics targeting eosinophilic asthma and novel inhaler devices introduce alternative treatment options.

Market Dynamics Influencing ADVAIR DISKUS 100/50

Patent and Intellectual Property

Initial patents protected ADVAIR until 2017 in key markets, after which generic competitors rapidly entered [3]. While brand exclusivity has diminished, the product maintains a premium positioning through data on efficacy and safety. Efforts to extend patent life via formulation upgrades or device innovations remain critical.

Pricing Strategies

Pricing pressures intensify due to increased generic competition. Manufacturers are adopting value-based pricing, bundling with services, and negotiating rebates with payers to preserve margins. Market access hinges on demonstrating cost-effectiveness relative to competing therapies.

Market Penetration and Adoption

Physician prescribing habits favor established combination therapies like ADVAIR, especially following guideline endorsements. However, patient adherence challenges, device usability concerns, and inhaler technique influence overall utilization.

Innovation and Product Development

Continued innovation encompasses:

• Device improvements: Development of more user-friendly inhalers enhances adherence.
• Combination upgrades: Fixed-dose combinations and triple therapies aim to expand indications.

Geographical Market Expansion

Developing markets in Asia-Pacific and Latin America exhibit rising demand for respiratory medicines, often driven by urban pollution and rising incomes. Manufacturers investing in these regions anticipate significant growth opportunities.

Regulatory and Reimbursement Landscape

Complex reimbursement frameworks, especially in the US and Europe, impact sales. Recent policy shifts favoring biosimilars and generics exert downward pressure on prices, demanding strategic market access approaches.

Financial Trajectory Projections

Historical Performance

In the fiscal year 2022, ADVAIR generated approximately USD 4.1 billion globally, representing a modest decline (~3%) from previous years due to generic entries [4].

Forecasted Trends (2023-2028)

• Market Share Dynamics: While patent expiration curtailed growth temporarily, strategic differentiation and new formulations could stabilize revenues.
• CAGR Estimates: Analysts project a compound annual decline of 2-3% over the next five years, primarily due to generic erosion [5].
• Potential Growth Catalysts:
  • Expansion into emerging markets.
  • Introduction of next-generation delivery devices.
  • Increased adoption in COPD management [6].

Revenue Forecast Breakdown

Year	Estimated Revenue (USD Billion)	Key Drivers
2023	~$3.9	Patent expiry impact, generic competition
2024	~$3.8	Market saturation, pricing pressures
2025	~$3.7	Stabilization with market share retention
2026	~$3.6	Strategic innovations, regional growth
2027	~$3.55	Continued competitive pressures
2028	~$3.5	Mature market, slow decline

Profitability Outlook

Gross margins are expected to remain compressed amid pricing pressures. Operating margins could decline correspondingly unless efficiency measures and new product launches offset revenue erosion.

Strategic Implications

To sustain its financial trajectory, stakeholders should prioritize:

• Patent and IP Strategies: Defending existing patents and exploring formulation innovations.
• Market Diversification: Expanding into fast-growing geographies.
• Device Innovation: Enhancing inhaler usability to improve adherence and differentiate from competitors.
• Pricing and Reimbursement Negotiation: Demonstrating value through real-world evidence.
• Pipeline Development: Investing in next-generation combination therapies and biologics to future-proof revenue streams.

Key Takeaways

• ADVAIR DISKUS 100/50 operates in a highly competitive, evolving market driven by epidemiology, regulatory frameworks, and technological innovation.
• Patent expirations and generic competition are pressures, but strategic product differentiation, innovation, and market expansion provide resilience.
• Revenue is forecasted to decline modestly over the coming five years, emphasizing the importance of proactive lifecycle management.
• Investing in device technology, regional expansion, and pipeline development will be pivotal for sustaining profitability.
• Stakeholders should prioritize demonstrating value, optimizing market access, and differentiating through innovation to navigate the complex landscape.

FAQs

1. How will patent expiration impact ADVAIR DISKUS revenues?
Patent expirations, occurred around 2017, led to increased generic competition, exerting downward pressure on prices and market share. Sustained profitability hinges on product differentiation and innovation beyond patent protection.

2. What strategies are companies adopting to maintain market share for ADVAIR?
Strategies include device improvements, expanding indications, entering emerging markets, and emphasizing real-world evidence to justify pricing and reimbursement negotiations.

3. How is the regulatory environment influencing ADVAIR's market prospects?
Regulatory agencies’ approval of generic equivalents and biosimilars challenge branded sales, necessitating strategic timing of product updates and lifecycle extensions.

4. What role do emerging markets play in ADVAIR's future growth?
Emerging markets offer significant growth potential due to increasing disease prevalence, rising incomes, and improving healthcare infrastructure, making regional expansion a key focus.

5. Are new formulations or delivery devices expected to alter ADVAIR’s financial trajectory?
Yes. Innovations that improve inhaler adherence and efficacy can reinforce brand loyalty and extend product lifecycle, positively influencing revenues.

References

[1] Allied Market Research. Respiratory Therapeutics Market. 2022.
[2] World Health Organization. Global Surveillance, Prevention and Control of Chronic Respiratory Diseases. 2021.
[3] U.S. Patent and Trademark Office. Patent expirations related to ADVAIR. 2017.
[4] GSK Annual Report 2022.
[5] EvaluatePharma. Respiratory Drugs Market Outlook. 2023.
[6] GlobalData. COPD Management Market Analysis. 2022.