ADVAIR DISKUS 250/50 Drug Patent Profile

Which patents cover Advair Diskus 250/50, and when can generic versions of Advair Diskus 250/50 launch?

Advair Diskus 250/50 is a drug marketed by Glaxo Grp Ltd and is included in one NDA.

The generic ingredient in ADVAIR DISKUS 250/50 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 250/50

A generic version of ADVAIR DISKUS 250/50 was approved as fluticasone propionate; salmeterol xinafoate by HIKMA on December 17^th, 2020.

Summary for ADVAIR DISKUS 250/50

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 250/50 at DailyMed

Recent Clinical Trials for ADVAIR DISKUS 250/50

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 250/50 clinical trials

Pharmacology for ADVAIR DISKUS 250/50

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

US Patents and Regulatory Information for ADVAIR DISKUS 250/50

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 250/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-002	Aug 24, 2000	AB	RX	Yes	Yes

Expired US Patents for ADVAIR DISKUS 250/50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxo Grp Ltd	ADVAIR DISKUS 250/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-002	Aug 24, 2000
Glaxo Grp Ltd	ADVAIR DISKUS 250/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-002	Aug 24, 2000
Glaxo Grp Ltd	ADVAIR DISKUS 250/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-002	Aug 24, 2000
Glaxo Grp Ltd	ADVAIR DISKUS 250/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-002	Aug 24, 2000
Glaxo Grp Ltd	ADVAIR DISKUS 250/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-002	Aug 24, 2000
Glaxo Grp Ltd	ADVAIR DISKUS 250/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-002	Aug 24, 2000
Glaxo Grp Ltd	ADVAIR DISKUS 250/50	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	021077-002	Aug 24, 2000

EU/EMA Drug Approvals for ADVAIR DISKUS 250/50

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 250/50

See the table below for patents covering ADVAIR DISKUS 250/50 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
Germany	4106379	Inhalationsgerät und Medikamentenpackung hierfür

Supplementary Protection Certificates for ADVAIR DISKUS 250/50

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
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

Market Dynamics and Financial Trajectory for ADVAIR DISKUS 250/50

Last updated: November 4, 2025

Introduction

ADVAIR DISKUS 250/50 (fluticasone propionate and salmeterol xinafoate inhalation powder) remains a pivotal pharmaceutical product in the management of asthma and chronic obstructive pulmonary disease (COPD). Its market trajectory is shaped by therapeutic efficacy, evolving healthcare regulatory landscapes, competitive dynamics, and emerging technological innovations. This analysis examines the current market position, growth prospects, regulatory influences, and financial implications of ADVAIR DISKUS 250/50 over the coming years.

Current Market Landscape

Therapeutic Position and Demand Drivers

ADVAIR DISKUS, a combination inhaler containing inhaled corticosteroid (ICS) and long-acting beta-agonist (LABA), has established itself as a first-line therapy for moderate-to-severe asthma and COPD management, especially for patients requiring step-up treatment. The drug's efficacy in reducing exacerbations and improving lung function drives sustained demand, especially within developed markets such as the U.S., Europe, and Japan [1].

Market Size and Penetration

As of 2022, the global respiratory therapeutics market was valued approximately at USD 20 billion, with inhaled asthma and COPD treatments accounting for about 45%. ADVAIR's segment’s estimated share stands at roughly 15-20%, translating into multi-billion-dollar revenues. The drug's adherence within prescribed cohorts anchors its revenue base, but growth potential hinges on market expansion and patient adherence improvement [2].

Competitive Landscape

Major competitors include Symbicort (budesonide/formoterol), Advair Diskus's successor products, and emerging biologics. Generic entries, especially post-patent exclusivity expiry, threaten revenue streams, compelling pharmaceutical companies to differentiate via formulation improvements, digital adherence tools, and expanded indications.

Regulatory and Patent Environment

Patent Expiry and Biosimilar Entry

ADVAIR DISKUS's primary patents expired around 2019-2020 in key markets, opening the floodgates for generics and biosimilars, which could significantly erode sales. Nonetheless, brand loyalty and formulation-specific patents continue to provide a temporarily protective moat.

Regulatory Approvals and Reimbursements

Regulatory bodies, such as the FDA and EMA, continue to approve new indications and device improvements, bolstering market access. Reimbursement policies, aligned with value-based care initiatives, heavily influence product utilization and profitability.

Market Dynamics Influencing Financial Trajectory

Assessing Growth Amid Patent Challenges

Post-patent, revenue decline is typical. However, companies strategically introduce fixed-dose combination reformulations, digital health integrations, and expanded indications to sustain revenues. For ADVAIR DISKUS, these tactics mitigate erosion but face diminishing returns over time.

Geographical Expansion Opportunities

Emerging markets, characterized by rising COPD and asthma prevalence, offer growth avenues. Improving healthcare access, increasing physician awareness, and pricing strategies tailored to economies of scale amplify growth prospects in countries like India and China.

Technological Innovations and Digital Integration

Digital inhalers equipped with adherence tracking and data analytics are transforming treatment paradigms. Incorporation of such devices can enhance patient compliance, translating into higher drug utilization rates and incremental revenues.

Pricing Strategies and Reimbursement Trends

Healthcare systems are moving towards cost-containment, incentivizing price reductions and formulary placements that favor generics and biosimilars. Strategic pricing adjustments and value-based contracts are essential to sustain profitability.

Financial Trajectory Analysis

Revenue Trends and Forecasts

Pre-patent expiry, ADVAIR DISKUS generated annual revenues exceeding USD 3 billion. Post-expiry, projections suggest an initial decline of 15–25% over 3-5 years, unless offset by innovation and market expansion initiatives. In the medium term, innovative formulations and digital enhancements could stabilize revenues at around USD 1.5–2 billion annually [3].

Profitability and Cost Management

Generic competition generally reduces gross margins from high 60-70% levels to approximately 30-40%. R&D investments in digital health, device innovation, and formulation improvements will influence profit margins. Efficient supply chain management and strategic partnerships mitigate margin erosion.

Market Entry and Growth Strategy Implications

Accelerating entry into emerging markets through local partnerships and tailored pricing can diversify revenue streams. Additionally, expanding indications for COPD and asthma, especially in under-penetrated populations, improves long-term financial sustainability.

Future Outlook

ADVAIR DISKUS 250/50’s market trajectory hinges on several key factors:

• Patent Proceedings and Generics: The expiration of key patents catalyzes generic entry, curbing revenues unless countered by reformulated products or new patents.
• Innovation and Digital Health: Embracing technology-driven adherence solutions could preserve premium pricing and market share.
• Regulatory Dynamics: Expansion into new indications and regions, contingent on approval pathways, yields growth opportunities.
• Market Penetration in Emerging Economies: Addressing barriers to access and affordability can open substantial revenue streams.

Given these dynamics, the projected financial trajectory suggests a declining phase over the next 5 years, stabilizing with strategic innovations and expansion in emerging markets. Without such adaptations, revenues are expected to decrease by approximately 20-30%, aligning with industry trends post-patent expiry.

Key Takeaways

• Patent expiries significantly impact ADVAIR DISKUS revenue, necessitating innovation and market expansion strategies.
• Digital health integration and device enhancements present opportunities for revenue stabilization and growth.
• Emerging markets offer untapped potential for growth, especially as asthma and COPD prevalence increase.
• Pricing pressures and reimbursement shifts demand strategic approaches to maintain profitability.
• Long-term sustainability hinges on diversification into new indications, technological adoption, and global strategic partnerships.

FAQs

1. How will patent expiry affect ADVAIR DISKUS’s market share?
Patent expiry exposes ADVAIR DISKUS to generic competition, typically leading to significant revenue declines unless offset by reformulations, expanded indications, or digital adherence solutions.

2. What role does digital health play in ADVAIR DISKUS’s future?
Digital inhalers with adherence tracking can improve patient outcomes, justify premium pricing, and foster patient loyalty, thereby mitigating revenue erosions caused by generics.

3. Are there opportunities in emerging markets for ADVAIR DISKUS?
Yes. Growing COPD and asthma burdens, rising healthcare access, and increasing awareness make emerging markets strategic growth zones, provided pricing and reimbursement strategies are tailored appropriately.

4. How do regulatory changes influence ADVAIR DISKUS’s financial trajectory?
Regulatory approvals for new indications or device improvements enable market expansion, while stringent reimbursement policies may challenge profitability, necessitating adaptive strategies.

5. What innovations could sustain ADVAIR DISKUS’s competitiveness?
Integrating digital adherence tools, developing next-generation formulations, expanding indications, and entering emerging markets are critical innovations for ongoing competitiveness.

References

[1] Global Market Insights, "Respiratory Therapeutics Market Size & Trends," 2022.
[2] IQVIA, "Global Respiratory Care Market Report," 2022.
[3] Evaluate Pharma, "Pharmaceutical Revenue Forecasts," 2023.