PROAIR RESPICLICK Drug Patent Profile

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

Proair Respiclick is a drug marketed by Teva Branded Pharm and is included in one NDA.

The generic ingredient in PROAIR RESPICLICK is albuterol sulfate. There are thirty-eight drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Proair Respiclick

A generic version of PROAIR RESPICLICK was approved as albuterol sulfate by SUN PHARM INDUSTRIES on December 5^th, 1989.

Summary for PROAIR RESPICLICK

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	65
Patent Applications:	5,190
Drug Prices:	Drug price information for PROAIR RESPICLICK
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PROAIR RESPICLICK
What excipients (inactive ingredients) are in PROAIR RESPICLICK?	PROAIR RESPICLICK excipients list
DailyMed Link:	PROAIR RESPICLICK at DailyMed

See drug prices for PROAIR RESPICLICK

Pharmacology for PROAIR RESPICLICK

Drug Class	beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists

US Patents and Regulatory Information for PROAIR RESPICLICK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Branded Pharm	PROAIR RESPICLICK	albuterol sulfate	POWDER, METERED;INHALATION	205636-001	Mar 31, 2015		RX	Yes	Yes

Expired US Patents for PROAIR RESPICLICK

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	PROAIR RESPICLICK	albuterol sulfate	POWDER, METERED;INHALATION	205636-001	Mar 31, 2015
Teva Branded Pharm	PROAIR RESPICLICK	albuterol sulfate	POWDER, METERED;INHALATION	205636-001	Mar 31, 2015
Teva Branded Pharm	PROAIR RESPICLICK	albuterol sulfate	POWDER, METERED;INHALATION	205636-001	Mar 31, 2015
Teva Branded Pharm	PROAIR RESPICLICK	albuterol sulfate	POWDER, METERED;INHALATION	205636-001	Mar 31, 2015

International Patents for PROAIR RESPICLICK

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

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1222811	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)
Israel	266617	משאף (Inhaler)
China	105597204	DOSE COUNTERS FOR INHALERS, INHALERS AND SHAFTS THEREOF
Eurasian Patent Organization	032332	СЧЕТЧИК ДОЗ ДЛЯ ИНГАЛЯТОРА И ИНГАЛЯТОР, СОДЕРЖАЩИЙ СЧЕТЧИК ДОЗ (DOSE COUNTER FOR AN INHALER AND INHALER COMPRISING A DOSE COUNTER)

Market Dynamics and Financial Trajectory for ProAir RespiClick

Last updated: July 27, 2025

Introduction

ProAir RespiClick (albuterol sulfate inhalation powder) is a dry powder inhaler (DPI) indicated for the relief and prevention of bronchospasm in patients with reversible obstructive airway disease, including asthma and COPD. As a key product within the bronchodilator segment, its market dynamics and financial performance are influenced by regulatory trends, competitive landscape, patient preferences, and broader healthcare policies. This report provides a comprehensive analysis of the current market landscape, underlying drivers, and future financial trajectory of ProAir RespiClick.

Market Overview and Regulatory Context

ProAir RespiClick received U.S. Food and Drug Administration (FDA) approval in 2018, gaining market exclusivity through its novel DPI formulation compared to traditional nebulizer and metered-dose inhalers (MDIs). The inhaler addresses an unmet need for portable, preservative-free, and ease-of-use inhalation therapies, especially among pediatric and elderly populations.

Regulatory trends emphasizing environmental benefits—particularly the phase-out of chlorofluorocarbon (CFC) propellants and push for environmentally sustainable inhalers—have further positioned DPI formulations like ProAir RespiClick favorably. Additionally, the FDA's focus on demonstrating therapeutic equivalence across inhaler devices influences market acceptance and reimbursement policies.

Competitive Landscape

ProAir RespiClick competes primarily against other inhalers, including:

• Proventil HFA and Ventolin HFA (MDIs)
• Xopenex HFA (levalbuterol inhaler)
• Dulera and other combination inhalers
• Respimat Soft Mist Inhaler formulations such as Spiriva Respimat

The market is highly competitive, with multifaceted considerations:

• Device preference: Patients exhibit varying preferences for DPIs versus MDIs, influenced by ease of inhalation, portability, and familiarity.
• Pricing and reimbursement: Price sensitivity and insurance coverage significantly affect patient access.
• Patent protections: Although ProAir RespiClick benefits from patent protections initially, patent cliffs and generic entrants threaten long-term exclusivity.

Recent biosimilar and generic developments in the bronchodilator space further intensify price competition.

Market Drivers Impacting ProAir RespiClick

1. Rising Prevalence of Asthma and COPD

Globally, the prevalence of asthma and COPD continues to increase, driven by aging populations, environmental pollution, and urbanization. In the US alone, over 25 million Americans have asthma, with approximately 16 million affected by COPD [2]. This expanding patient base sustains demand for effective bronchodilators like ProAir RespiClick.

2. Patient and Physician Preferences

The portable, preservative-free design of ProAir RespiClick appeals to users seeking convenience and minimal environmental impact over traditional MDIs. Physicians increasingly prescribe DPIs due to their ease of use, especially for pediatric and geriatric populations, influencing market uptake.

3. Environmental Regulatory Policies

Environmental regulations, such as the European Union's phasing out of HFA-propelled inhalers, influence policy directions globally. The shift toward eco-friendly inhalers benefits DPI formulations like ProAir RespiClick, which contain no hazardous propellants.

4. Reimbursement and Insurance Trends

Coverage policies directly impact accessibility. In the U.S., prior authorization and formulary placement influence prescription volumes. Insurers increasingly incentivize use of environmentally friendly inhalers, favoring ProAir RespiClick’s positioning.

5. Competitive Innovation and Patent Expirations

Innovation in device design and formulation progresses rapidly. The expiry of key patents opens doors for generic competition, which could erode market share and compress margins.

Financial Trajectory and Portfolio Outlook

Historical Financial Performance

As of recent reports, ProAir RespiClick's revenue contributions have grown steadily post-launch, driven by expanding prevalence and favorable device characteristics. According to regulatory filings, the product has maintained a significant market share in the U.S. outpatient bronchodilator segment, with revenues estimated at several hundred million dollars annually.

Future Revenue Projections

Industry analysts project that ProAir RespiClick's sales will experience moderate growth through 2025 due to:

• Growing patient population
• Increased adoption in pediatric and elderly demographics
• Enhanced formulary positioning

However, this growth trajectory is sensitive to:

• Patent expiration timelines (anticipated around 2025–2026), likely leading to increased generic competition [3].
• Pricing pressures driven by cost-containment policies in the US and international markets.
• Market saturation in mature markets, limiting high-growth opportunities.

Impact of Patent Expiry and Generic Entry

Patent expiration significantly influences projected revenue streams. Once patent barriers lift, generic formulations are expected to enter, reducing price premiums. Historical precedence with inhalers indicates a sharp decline in branded sales within 12–18 months post-generic approval.

Potential Strategic Responses

Manufacturers typically counter patent cliffs through:

• Line extensions and new formulations
• Cost reduction strategies
• Enhanced patient adherence initiatives
• Broader geographic expansion, especially into emerging markets

ProAir RespiClick’s parent company is investing in device innovation and expansion initiatives to mitigate revenue erosion.

Emerging Market and International Contributions

Emerging markets present new growth avenues, driven by increasing respiratory disease prevalence and expanding healthcare infrastructure. Regulatory approvals outside the U.S. and Europe could catalyze revenue streams, albeit with variable regulatory hurdles.

Market Challenges and Opportunities

Challenges

• Patent expiration and generic competition
• Pricing pressures and reimbursement constraints
• Changing physician prescribing behavior favoring other inhaler types
• Global environmental regulatory shifts limiting inhaler designs

Opportunities

• Device innovation to extend patent life and improve adherence
• Partnerships and licensing agreements in emerging markets
• Integration with digital health tools for improved patient outcomes
• Development of combination therapies with prolonged action formulations

Conclusion and Future Outlook

ProAir RespiClick occupies a strategic position within the bronchodilator market, capitalizing on environmental sustainability and patient-centric design trends. Its financial trajectory will hinge predominantly on patent protection duration, the pace of generic competition, and the evolution of healthcare policies favoring environmentally friendly devices.

While near-term growth remains supported by increasing disease prevalence and device preference, long-term prospects necessitate strategic innovation. Companies investing in device enhancements, digital integration, and geographic expansion can sustain revenue and preserve market share amidst impending patent expirations.

Key Takeaways

• The demand for ProAir RespiClick benefits from the rising global prevalence of asthma and COPD, alongside patient and physician preferences for portable, preservative-free inhalers.
• Environmental policies favor DPI formulations, positioning ProAir RespiClick advantageously in the market.
• Patent expiration around 2025–2026 poses a significant risk, likely prompting increased generic competition and price erosion.
• Strategic responses such as device innovation, expansion into emerging markets, and integration with digital health tools are critical for maintaining financial stability.
• Future growth depends on effectively navigating regulatory shifts, reimbursement landscapes, and competitive dynamics.

FAQs

1. When is ProAir RespiClick expected to face generic competition?
Patent protection for ProAir RespiClick was granted in 2018 and is expected to expire around 2025–2026, after which generic competitors are likely to enter the market, potentially impacting sales.

2. How does ProAir RespiClick compare to traditional inhalers in terms of patient adherence?
ProAir RespiClick’s dry powder inhaler design offers ease of use and portability, which can improve adherence, particularly among children and elderly patients who benefit from a preservative-free, less complex inhaler.

3. What are the environmental advantages of ProAir RespiClick?
ProAir RespiClick contains no CFC propellants, aligning with environmental regulations and reducing impact compared to older MDIs which used harmful chlorofluorocarbons.

4. What strategies are manufacturers employing to sustain revenue post-patent expiration?
Strategies include device line extensions, digital health integrations, expanding into new markets, and exploring combination therapies to differentiate offerings and prolong product lifecycle.

5. How do reimbursement policies influence the adoption of ProAir RespiClick?
Coverage decisions, formulary placements, and prior authorization requirements directly affect prescription rates. Favorable reimbursement policies bolster patient access and sales volume.

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Sources:

1. FDA. ProAir RespiClick: FDA approval and regulatory filings.
2. CDC. Asthma Surveillance Data.
3. IQVIA. Market reports on inhaler patent expirations and generic entry forecasts.