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 four patents protecting this drug.

This drug has one hundred and thirty-six patent family members in thirty-five countries.

The generic ingredient in AIRDUO RESPICLICK is fluticasone propionate; salmeterol xinafoate. There are twenty-nine drug master file entries for this compound. Twelve 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:	136
US Patents:	4
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 four US patents.

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	Yes					Y
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-002	Jan 27, 2017		RX	Yes	Yes					Y
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-001	Jan 27, 2017		RX	Yes	Yes					Y
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-003	Jan 27, 2017		RX	Yes	Yes					Y
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-001	Jan 27, 2017		RX	Yes	Yes					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
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-001	Jan 27, 2017
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-002	Jan 27, 2017
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-003	Jan 27, 2017
Teva Pharm	AIRDUO RESPICLICK	fluticasone propionate; salmeterol xinafoate	POWDER;INHALATION	208799-002	Jan 27, 2017

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
United Kingdom	0115519
World Intellectual Property Organization (WIPO)	2011054527
Hong Kong	1222815	用於呼吸驅動的吸入器的順從性監控模塊 (COMPLIANCE MONITORING MODULE FOR A BREATH-ACTUATED INHALER)
Mexico	2017002551
Japan	2021000468

Supplementary Protection Certificates for AIRDUO RESPICLICK

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	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	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	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

Market Dynamics and Financial Trajectory for Airduo Respiclick

Last updated: February 20, 2026

What is the Market Position of Airduo Respiclick?

Airduo Respiclick is a combination inhaler for asthma and COPD treatment containing fluticasone propionate and salmeterol. It was approved by the FDA in 2017. Its market presence remains limited compared to leading brands such as Advair Diskus and Symbicort, due to its market entry timing and competitive landscape.

What Are Its Core Markets and Adoption Rates?

Geographic Market Penetration

• Primary markets: United States, Europe, Asia-Pacific.
• U.S. market: It is classified under prescription asthma and COPD inhalers, with FDA approval in 2017.
• Europe: Approved via the European Medicines Agency (EMA) in the same year, with variable uptake across member states.

Adoption Metrics

• Prescriptions: Estimated to account for less than 5% of combined inhaled corticosteroid/long-acting beta-agonist (ICS/LABA) inhalers sold.
• Prescribing trends: Stable but slow growth, reflecting incumbent competition and physician familiarity with established products.

What Is the Competitive Landscape?

Major Competitors

Product	Market Share (2022)	Key Features	Approval Year
Advair Diskus	45%	Established, high brand recognition	2002
Symbicort	30%	Dual-action inhaler, broad use	2009
Breo Ellipta	12%	Simplified regimen, once-daily	2013
Airduo Respiclick	<5%	New entrant, FDA approval 2017	2017

Barriers to Market Penetration

• Strong brand loyalty to existing inhalers.
• Physician familiarity and inertia.
• Limited marketing spend regarding Airduo Respiclick.
• Price point comparable but not significantly lower than competitors.

What Are the Financial Trajectories and Revenue Outlooks?

Revenue Estimates

• Year 2022: Estimated global sales around $100 million.
• Growth Strategy: Focused on increasing prescriber awareness, patient adherence, and geographic expansion.

Forecasts (Next 5 Years)

Year	Projected Revenue	Growth Rate	Assumptions
2023	$125 million	25%	Slight increase due to new marketing efforts
2024	$150 million	20%	Expansion into additional markets and clinician awareness
2025	$180 million	20%	Adoption growth stabilizes at higher levels
2026	$200 million	11%	Market saturation approaching
2027	$210 million	5%	Competitive pressures increase

Pricing and Reimbursement Factors

• Approximate retail price: $3,200 per year for typical patient.
• Reimbursement: Covered by major insurers; patient copays vary.
• Cost-effectiveness analyses favor more established brands for certain patient groups, limiting premium pricing opportunities.

What Are Major Influencing Policies?

• FDA regulatory pathway finalized for inhalers after approval of generic competition.
• EU market: Continued harmonization of inhaler standards affecting device approval.
• Price control measures emerging in some markets, potentially limiting revenue growth.

Summary of Key Financial Considerations

• Limited market share coupled with high-value labeling suggests room for growth.
• Growing indications for COPD and asthma driven by aging populations.
• Entrenched competitor dominance and slow prescriber acceptance challenge sales expansion.
• Market expansion relies heavily on geographic and formulary positioning.

Key Takeaways

Airduo Respiclick remains a niche player within an established competitive landscape. While sales growth is projected at 20% annually over the next two years, substantial barriers include brand loyalty and physician familiarity. Geographic expansion and increased prescriber awareness could materially influence its revenue trajectory. Price sensitivity and reimbursement policies influence market penetration potential.

FAQs

1. What differentiates Airduo Respiclick from competitors?
   It offers an alternative inhaler device with a specific design that appeals to certain patient populations, but it does not have proprietary advantages over established brands like Advair or Symbicort.

2. What is its market share in the inhaler segment?
   Less than 5% globally, mainly due to late market entry and stiff competition.

3. Are there patent protections that influence sales?
   Its core patent protections have expired; competitiveness relies on device innovation and marketing.

4. What are the primary drivers for growth?
   Market expansion into new regions, increasing prevalence of respiratory conditions, and formulary inclusion.

5. How prone is it to pricing pressures?
   Price controls in Europe and the U.S. could limit profit margins and revenue growth.

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References

[1] U.S. Food & Drug Administration. (2017). FDA approves Airduo Respiclick for asthma and COPD.
[2] European Medicines Agency. (2017). Approval details for Airduo Respiclick.
[3] IQVIA. (2022). Prescription drug sales—Respiratory inhalers.
[4] GlobalData. (2023). Inhaler Market Analysis and Forecast.