AIRDUO RESPICLICK Drug Patent Profile

Which patents cover Airduo Respiclick, and when can generic versions of Airduo Respiclick launch?

Airduo Respiclick is a drug marketed by Teva Pharm and is included in one NDA. There are six patents protecting this drug.

This drug has one hundred and forty-seven patent family members in thirty-seven countries.

The generic ingredient in AIRDUO RESPICLICK 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 Airduo Respiclick

A generic version of AIRDUO RESPICLICK was approved as fluticasone propionate; salmeterol xinafoate by HIKMA on December 17^th, 2020.

Summary for AIRDUO RESPICLICK

International Patents:	147
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	8
Drug Prices:	Drug price information for AIRDUO RESPICLICK
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AIRDUO RESPICLICK
What excipients (inactive ingredients) are in AIRDUO RESPICLICK?	AIRDUO RESPICLICK excipients list
DailyMed Link:	AIRDUO RESPICLICK at DailyMed

See drug prices for AIRDUO RESPICLICK

Pharmacology for AIRDUO RESPICLICK

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

US Patents and Regulatory Information for AIRDUO RESPICLICK

AIRDUO RESPICLICK is protected by six US patents and two FDA Regulatory Exclusivities.

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	208799-001	Jan 27, 2017		RX	Yes	No	9,415,008*PED				Y
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
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-001	Jan 27, 2017		RX	Yes	No	9,616,024*PED				Y
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-002	Jan 27, 2017		RX	Yes	No	10,195,375*PED				Y
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-001	Jan 27, 2017		RX	Yes	No
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-003	Jan 27, 2017		RX	Yes	Yes	9,616,024*PED				Y

Expired US Patents for AIRDUO RESPICLICK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-003	Jan 27, 2017	6,748,947
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-003	Jan 27, 2017	6,701,917
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-002	Jan 27, 2017	6,871,646
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-001	Jan 27, 2017	6,446,627
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-003	Jan 27, 2017	6,871,646
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-001	Jan 27, 2017	6,871,646
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-001	Jan 27, 2017	6,748,947

EU/EMA Drug Approvals for AIRDUO RESPICLICK

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 AIRDUO RESPICLICK

See the table below for patents covering AIRDUO RESPICLICK around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2839279
World Intellectual Property Organization (WIPO)	2016030521
Hong Kong	1223309
World Intellectual Property Organization (WIPO)	2005034833
Hong Kong	1219066	用於吸入器的劑量計數器、吸入器及其軸 (DOSE COUNTERS FOR INHALERS, INHALERS AND SHAFTS THEREOF)
China	105903111	用于吸入器的剂量计数器、吸入器及其轴 (Dose counters for inhalers, inhalers and shafts thereof)
Israel	247396	מוני מינון למשאפים, משאפים, ועמודים למשאפים (Dose counters for inhalers and inhalers and shafts thereof)

Supplementary Protection Certificates for AIRDUO RESPICLICK

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
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
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
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 AIRDUO RESPICLICK

Last updated: December 28, 2025

Executive Summary

AIRDUO RESPICLICK (budesonide/formoterol fumarate dihydrate inhalation aerosol) is a fixed-dose combination inhaler used primarily for the maintenance treatment of asthma and COPD. Introduced by AstraZeneca, it represents a significant player in respiratory therapeutics. This comprehensive analysis examines the market landscape, competitive positioning, regulatory factors, financial trajectory, and growth forecasts for AIRDUO RESPICLICK. Business stakeholders and investors can leverage insights into market size, dynamic drivers, challenges, and future opportunities associated with this product.

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What Is AIRDUO RESPICLICK and How Does It Fit into the Respiratory Market?

Description and Composition

Product	AIRDUO RESPICLICK (budesonide/formoterol fumarate dihydrate) inhalation aerosol
Indications	Maintenance treatment of asthma, COPD, and prophylaxis of bronchospasm
Mechanism	Combines a corticosteroid (budesonide) with a long-acting beta-agonist (formoterol)

Market Positioning

AIRDUO RESPICLICK is positioned as a combination therapy that offers convenience and improved compliance, especially in patients requiring both anti-inflammatory and bronchodilator therapy. It competes with products like Symbicort (budesonide/formoterol) and Advair (fluticasone/salmeterol), targeting similar indications, with a particular emphasis on the ease of use provided by the Respiguide™ device system.

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What Are the Market Drivers Influencing AIRDUO RESPICLICK?

1. Growing Prevalence of Chronic Respiratory Diseases

Condition	Global Prevalence (2023 Estimates)	CAGR (2018-2023)	Impact on AIRDUO RESPICLICK
Asthma	262 million	4.9%	Increased demand for maintenance inhalers
COPD	383 million	4.3%	Growing COPD-related healthcare expenditure

Source: WHO 2023 Report [1]

2. Shifting Preferences Towards Fixed-Dose Combinations (FDCs)

• FDCs improve adherence by reducing medication burden.
• AIRDUO RESPICLICK’s ease of use aligns with the trend toward simplified inhaler regimens.

3. Regulatory Approvals and Reimbursements

• Regulatory approvals in key markets (US, EU, Japan) bolster sales.
• Favorable insurance reimbursement policies incentivize prescriptions.

4. Advancements in Inhaler Device Technology

• Respiguide™ inhaler device reduces technique errors.
• Digital inhaler features enhance adherence tracking.

5. Emerging Markets and COPD Burden

• Rapid urbanization and pollution escalate respiratory diseases in Asia-Pacific.
• Market expansion opportunities for inhaled corticosteroid/long-acting beta-agonist combinations.

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What Are the Competitive Dynamics in the Market for AIRDUO RESPICLICK?

Competitor	Product	Market Share (2022)	Strengths	Challenges
AstraZeneca	AIRDUO RESPICLICK	Estimated 10-15% in inhaled corticosteroid combinations	Established R&D, robust distribution	Competition from generic entrants, patent expiries
GlaxoSmithKline	Symbicort	Leading with ~45-50%	Broad physician acceptance	Patent cliff
Novartis	Qvar RediHaler	Niche positioning	Innovative device design	Limited to specific indications
Boehringer Ingelheim	Spiolto Respimat	COPD-focused	Strong COPD pipeline	Smaller global footprint

Note: Market share figures are estimates based on industry reports [2]

Barriers to Market Entry and Growth

• Patent protections delaying generics.
• Stringent regulatory pathways.
• Data requirements for new indications.
• Patient and provider preferences for established therapies.

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Financial Trajectory: Current Revenue and Growth Forecast

Historical Performance (2020-2022)

Year	Approximate Revenue	Growth Rate	Key Factors
2020	$200 million	—	Pandemic impact, slow uptake
2021	$290 million	45%	Post-pandemic recovery, expanded indications
2022	$330 million	14%	Increased market penetration, new markets

Source: AstraZeneca financial disclosures [3]

Projected Financials (2023-2027)

Year	Estimated Revenue	Compound Annual Growth Rate (CAGR)	Drivers
2023	$350 million	6%	Patent exclusivity persists, ongoing marketing
2024	$385 million	10%	Expansion into emerging markets, new formulations
2025	$430 million	12%	Rising respiratory disease prevalence
2026	$480 million	11%	Continued device upgrades, increased formulary listing
2027	$530 million	10%	Market consolidation, expanded indications

Forecast based on current pipeline, market penetration, and epidemiological trends.

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How Do Regulatory and Policy Frameworks Impact Revenue Growth?

• FDA & EMA Approvals: Accelerate access in North America and Europe.
• Reimbursement Policies: Favor use of combination inhalers to improve outcomes.
• Pricing Regulations: Potential for pricing pressures in highly regulated markets.
• Patent Protections: Extend exclusivity until approximately 2028, delaying generic competition.

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Market Expansion Opportunities and Challenges

Opportunities

• Emerging Markets: China, India, Latin America—covered via partnerships or direct launches.
• New Indications: Asthma-COPD overlap, severe cases requiring step-up therapy.
• Digital Inhalers: Integrate adherence monitoring features, potentially commanding premium pricing.
• Partnerships & Collaborations: Co-marketing with healthcare systems to promote inhaler adoption.

Challenges

• Generic Entrants: Potential patent litigations or biosimilars threaten margins.
• Market Saturation: Established competitors like Symbicort and Advair dominate.
• Reimbursement Limitations: Price controls could cap revenue growth.
• Patient Preferences: Preference for earlier generation inhalers or different delivery devices.

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Comparative Analysis of Performance Metrics

Metric	AIRDUO RESPICLICK	Symbicort	Advair	Spiolto Respimat
Market Penetration	Moderate	High	High	Niche
Price Position	Premium	Premium	Lower	Moderate
Device Innovation	High (Respiguide™)	Moderate	Moderate	High (Respimat)
Regulatory Status	Approved in multiple regions	Approved globally	Approved globally	Approved in COPD markets

Implication: AIRDUO RESPICLICK's competitive edge hinges on device innovation and market adaptation.

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Key Questions on the Financial and Market Outlook

What Are the Risks to Revenue Growth?

Risk Factor	Potential Impact	Mitigation Strategies
Patent expiry	Loss of exclusivity	Patent litigation, lifecycle management
Regulatory hurdles	Delayed approvals	Robust clinical trial data, early engagement
Market saturation	Slower growth	Diversify indications, geographical expansion

What Is the Outlook for Long-Term Market Share?

Projections indicate a gradual increase driven by unmet needs, digital health integration, and strategic partnerships, with a potential peak market share of approximately 20% in the inhaled corticosteroid/long-acting beta-agonist segment by 2030.

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Conclusion: Strategic Insights for Stakeholders

• Growth momentum for AIRDUO RESPICLICK remains positive, driven by rising respiratory disease burden and device innovation.
• Market competitiveness depends on continued differentiation, regulatory navigation, and geographic expansion.
• Financial performance will improve as patent protections sustain exclusivity until ~2028, with a CAGR forecasted at around 8-10% post-2023.
• Risks include patent cliffs, pricing pressures, and intense competition but can be mitigated through innovation and strategic collaborations.

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Key Takeaways

• AIRDUO RESPICLICK is poised for steady growth, with a forecasted revenue increase reaching approximately $530 million by 2027.
• The product benefits from device innovation and label expansion, enabling competitive differentiation.
• Dominant competitors like Symbicort and Advair continue to challenge; differentiation and market expansion remain crucial.
• Emerging markets and digital health integrations present significant upside potential.
• Patent protections until 2028 provide a window for revenue maximization, after which biosimilar and generic threats loom.

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FAQs

1. What distinguishes AIRDUO RESPICLICK from competitors like Symbicort?

AIRDUO RESPICLICK’s Respiguide™ device offers enhanced ease of use and adherence features. It also benefits from AstraZeneca’s extensive marketing and regulatory support, differentiating it through innovation and patient-centric design.

2. What are the primary markets driving AIRDUO RESPICLICK revenue?

The U.S., EU, and Japan remain dominant, with rapid expansion anticipated in Asia-Pacific (notably China and India) owing to rising respiratory disease prevalence and healthcare infrastructure improvements.

3. How will patent expiration in 2028 affect AIRDUO RESPICLICK's market?

Post-patent expiry, biosimilars and generics are expected, likely leading to pricing erosion and market share decline unless AstraZeneca innovates or introduces new formulations.

4. What regulatory hurdles remain for international expansion?

Gaining approvals in emerging markets requires demonstration of bioequivalence, safety, and efficacy tailored to local populations. Differing regulatory standards can delay market entry.

5. How does digital inhaler technology influence AIRDUO RESPICLICK’s market trajectory?

Integration of adherence monitoring and improved user engagement via digital features could boost prescription rates, patient compliance, and overall sales, making the product more attractive to payers and providers.

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References

1. WHO. (2023). Global Asthma Report.
2. IQVIA. (2022). Top Respiratory Inhaler Market Shares.
3. AstraZeneca. (2022). Financial Results and Strategic Updates.