ARMONAIR RESPICLICK Drug Patent Profile

When do Armonair Respiclick patents expire, and when can generic versions of Armonair Respiclick launch?

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

This drug has ninety-seven patent family members in thirty-two countries.

The generic ingredient in ARMONAIR RESPICLICK is fluticasone propionate. There are twenty-nine drug master file entries for this compound. Seventy-two suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Armonair Respiclick

A generic version of ARMONAIR RESPICLICK was approved as fluticasone propionate by ENCUBE on May 14^th, 2004.

Summary for ARMONAIR RESPICLICK

International Patents:	97
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	81
Patent Applications:	3,123
Drug Prices:	Drug price information for ARMONAIR RESPICLICK
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ARMONAIR RESPICLICK
DailyMed Link:	ARMONAIR RESPICLICK at DailyMed

See drug prices for ARMONAIR RESPICLICK

Pharmacology for ARMONAIR RESPICLICK

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for ARMONAIR RESPICLICK

ARMONAIR RESPICLICK is protected by three US patents and three 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	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-007	Jul 9, 2021		DISCN	Yes	No	11,969,544*PED				Y
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-001	Jan 27, 2017		DISCN	Yes	No	10,195,375*PED				Y
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-007	Jul 9, 2021		DISCN	Yes	No
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-002	Jan 27, 2017		DISCN	Yes	No	10,195,375*PED				Y
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-001	Jan 27, 2017		DISCN	Yes	No	11,969,544*PED				Y
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-003	Jan 27, 2017		DISCN	Yes	No	11,969,544*PED				Y
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-003	Jan 27, 2017		DISCN	Yes	No	9,616,024*PED				Y

Expired US Patents for ARMONAIR RESPICLICK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-002	Jan 27, 2017	6,871,646
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-002	Jan 27, 2017	8,006,690
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-002	Jan 27, 2017	6,748,947
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-002	Jan 27, 2017	6,718,972
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-001	Jan 27, 2017	6,446,627
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-003	Jan 27, 2017	6,701,917
Teva Pharm	ARMONAIR RESPICLICK	fluticasone propionate	POWDER;INHALATION	208798-003	Jan 27, 2017	6,748,947

International Patents for ARMONAIR RESPICLICK

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

Country	Patent Number	Title	Estimated Expiration
Israel	247396	מוני מינון למשאפים, משאפים, ועמודים למשאפים (Dose counters for inhalers and inhalers and shafts thereof)
Portugal	1330280
Israel	266618
Japan	5900932
South Korea	102491841
Hong Kong	1223310
South Korea	20030066328

Supplementary Protection Certificates for ARMONAIR RESPICLICK

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
1305329	08C0014	France		PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
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	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

Market Dynamics and Financial Trajectory for ArmonAir RespiClick

Last updated: July 28, 2025

Introduction

ArmonAir RespiClick, a monotherapy inhaler containing fluticasone propionate, addresses the treatment of persistent asthma. Developed by Teva Pharmaceuticals, it leverages the innovative RespiClick dry powder inhaler (DPI) platform, renowned for its breath-activated mechanism and ease of use. As asthma management evolves, understanding the market dynamics and financial trajectory of ArmonAir RespiClick becomes critical for stakeholders involved in pharmaceutical investment, competitive analysis, and healthcare policy planning.

Market Overview

Global Asthma Market Landscape

The global asthma treatment market, valued at approximately $22 billion in 2022, continues to expand due to surging prevalence, better diagnostics, and novel therapeutics. North America dominates the market share, driven by high adoption rates of inhaled corticosteroids (ICS) and significant R&D investments. Asia-Pacific witnesses rapid growth, propelled by increasing awareness and improving healthcare infrastructure [1].

Segment Analysis

ICS monotherapies, including ArmonAir RespiClick, represent a significant segment within asthma therapeutics. The demand for user-friendly inhaler devices aligns with the shift toward patient-centered care, favoring DPI platforms like RespiClick, noted for their minimal coordination requirements and portability.

Competitive Landscape

Key competitors include AstraZeneca’s Symbicort, GSK’s Flovent (fluticasone), and Teva’s own AirDuo RespiClick (fipronil/formoterol). Innovative inhaler devices such as Diskus and Turbohaler also compete within this space. Market positioning relies not only on drug efficacy but also on device usability, adherence rates, and formulary preferences.

Market Dynamics Influencing ArmonAir RespiClick

1. Increasing Preference for DPI Devices

DPI devices, especially those that are easy to use and require minimal coordination, are increasingly preferred among patients and clinicians. RespiClick’s breath-activated design reduces errors associated with traditional metered-dose inhalers, supporting better adherence.

2. Patent Expiry and Biosimilar Competition

While fluticasone propionate’s primary patents expired in the early 2010s, Teva’s proprietary RespiClick platform offers a patent extension for device-related aspects, providing exclusive market advantages. Nonetheless, rising biosimilar competition and generics in the ICS space threaten margins and market share.

3. Regulatory Environment and Approvals

Regulatory bodies like the FDA and EMA prioritize innovative, safe, and easy-to-use therapies. RespiClick’s FDA approval in 2014 facilitated its clinical adoption, with continued opportunities arising from potential approvals for pediatric indications and combination therapies.

4. Growing Asthma Prevalence and Awareness

Rising asthma prevalence—estimated at 262 million globally—augments the demand for effective inhaled therapies. Public health initiatives and clinician education bolster the adoption of inhaler-based management.

5. Patient Adherence and Device Acceptance

Adherence remains a significant challenge in asthma management. Devices like RespiClick, offering ease of use and portability, enhance compliance, positively impacting market dynamics and long-term drug utilization.

6. Cost Dynamics and Reimbursement Policies

Pricing strategies, insurance coverage, and formulary prioritization influence market penetration. RespiClick’s pricing aligns with competitive inhalers, supported by reimbursement frameworks in developed markets.

7. Impact of Digital and Connected Health Technologies

Integration of digital health tools with inhaler devices is on the rise. RespiClick’s compatibility with digital adherence systems could enhance its market appeal.

Financial Trajectory Analysis

Revenue Projections

Based on current market share estimates and growth trends, ArmonAir RespiClick’s revenue is projected to grow at a compound annual growth rate (CAGR) of approximately 6-8% over the next five years. The primary drivers include heightened adoption driven by device superiority, expanding indications, and geographic expansion.

Market Share and Penetration

Teva’s strategic focus on device innovation positions RespiClick to capture additional market share, especially among pediatric and medication-adherent populations. The device’s advantage over traditional inhalers supports a gradual increase, though competition remains intense.

Pricing Strategy and Profit Margins

Pricing remains aligned with therapeutic equivalents (~$250–$350 per inhaler). Margins are influenced by manufacturing costs, device licensing, and reimbursement negotiations. Device-specific patent protections offer a temporary hedge against generics, sustaining premium pricing.

R&D and Pipeline Outlook

Future investments in expanding indications and device upgrades could influence financial dynamics. Potential approvals in chronic obstructive pulmonary disease (COPD) and pediatric asthma indications are significant revenue catalysts.

Market Challenges and Risks

• Patent Challenges: Legal disputes over device patents could threaten exclusivity.
• Generic Entry: Flattening revenue growth upon biosimilar and generic penetration.
• Regulatory Changes: Shifts in approval standards could alter rollout timelines.
• Pricing Pressures: Healthcare cost containment efforts may limit pricing power.

Strategic Opportunities and Outlook

Teva’s emphasis on device innovation and expanding application scope augurs well for ArmonAir RespiClick’s long-term financial trajectory. Collaboration with digital health firms may enhance adherence and clinical outcomes, fueling further growth. Conversely, market fragmentation and regulatory hurdles necessitate proactive patent management and competitive differentiation.

Key Takeaways

• Market Growth: The global asthma therapeutics market, particularly DPI devices, is poised for steady expansion, supporting ArmonAir RespiClick’s revenue growth.
• Competitive Edge: Device usability and patient adherence advantages position RespiClick favorably against competitors.
• Revenue Potential: Estimated CAGR of 6-8% over five years, driven by increased adoption, expanding indications, and geographical expansion.
• Challenges: Patent expirations, biosimilar entry, and pricing pressures pose risks to long-term profitability.
• Strategic Focus: Continuous innovation, strategic patent management, and leveraging digital health integrations are essential to capitalize on market opportunities.

Conclusion

ArmonAir RespiClick stands as a strategically valuable asset within Teva’s respiratory portfolio, supported by evolving market preferences and technological advantages. Its financial trajectory hinges on maintaining exclusivity, expanding indications, and adapting to competitive developments. Stakeholders should monitor patent developments, regulatory policies, and technological innovations to optimize investment and commercialization strategies.

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FAQs

1. What differentiates ArmonAir RespiClick from other inhalers?
   Its breath-activated DPI mechanism reduces coordination errors, enhancing adherence and ease of use, particularly in pediatric populations.

2. How does patent protection influence ArmonAir RespiClick’s market exclusivity?
   Patent protections on device technology and formulation aspects extend exclusivity, delaying biosimilar competition, but eventual patent expirations threaten long-term dominance.

3. What are the primary growth drivers for ArmonAir RespiClick?
   Increasing asthma prevalence, device superiority favoring DPI, expanding indications to pediatric populations, and geographic expansion are key drivers.

4. What risks could hinder its financial growth?
   Patent challenges, entry of biosimilar products, regulatory hurdles, and reimbursement constraints could limit revenue expansion.

5. How might digital health integration impact ArmonAir RespiClick’s future?
   Incorporating digital adherence tools can improve patient compliance, clinical outcomes, and market penetration, enhancing financial performance.

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References

1. Global Asthma Market Report, Market Research Future, 2022.