PROAIR RESPICLICK Drug Patent Profile

Which patents cover Proair Respiclick, 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-nine 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:	6,239
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
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
Japan	5806354
Japan	5900932
South Korea	20050048687
South Korea	20230028775
South Korea	20170048484

Market Dynamics and Financial Trajectory for PROAIR RESPICLICK

Last updated: December 31, 2025

Executive Summary

ProAir Respiclick (albuterol sulfate inhalation powder) is a prescription bronchodilator primarily used for the treatment and prevention of bronchospasm in patients with reversible airway obstruction, including asthma and chronic obstructive pulmonary disease (COPD). Positioned within the competitive landscape of inhaled beta-agonists, ProAir Respiclick benefits from favorable market trends such as rising asthma prevalence, increasing COPD rates, and a growing preference for dry powder inhalers (DPIs).

This analysis explores the key market drivers, competitive environment, regulatory considerations, and financial outlook, offering insights for stakeholders and investors seeking to understand the future trajectory of ProAir Respiclick.

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1. Market Overview and Size

Global and U.S. Market for Bronchodilators

Parameter	Value/Estimate	Details
Global COPD Drugs Market (2022)	~$37 billion	Expected CAGR: 4.7% (2022-2027) [1]
Global Asthma Drugs Market (2022)	~$28 billion	Expected CAGR: 3.8% [2]
U.S. Respiratory Drugs Market (2022)	~$13.2 billion	Dominated by bronchodilators; key players include GlaxoSmithKline, AstraZeneca, and Teva [3]

ProAir Respiclick Positioning

• Approved in 2015 by the FDA
• Key competitor to Diazepam-based inhalers (e.g., Ventolin HFA)
• In 2022, reported US sales: ~$1.2 billion (IBID), representing a significant share in DPI segment

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2. Key Market Drivers

Increasing Prevalence of Respiratory Diseases

• Asthma: Affects approximately 25 million Americans, with prevalence rising by 4-6% annually [4].
• COPD: Over 16 million diagnosed in the U.S., with projections to surpass 20 million by 2030 due to aging populations and smoking rates [5].

Shift Toward Dry Powder Inhalers (DPIs)

• DPIs like ProAir Respiclick offer advantages over metered-dose inhalers (MDIs): fewer excipients, no need for propellants, and ease of use.
• The global DPI market is projected to grow at a CAGR of 6.4% from 2022 to 2028 [6].

Advancements in Inhaler Design and Patient Preference

• Improved ease of use, portability, and dose confirmation features drive adoption.
• Digital integrations (e.g., Bluetooth-enabled devices) further enhance patient adherence.

Regulatory Support

• FDA initiatives promoting generic and innovative inhalers.
• Favorable health policies emphasizing inhaler replacement to reduce healthcare costs.

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3. Competitive Landscape

Major Competitors

Product	Type	Market Share (2022)	Notes
ProAir Respiclick (Aerosolized Albuterol Powder)	DPI	~35%	FDA-approved in 2015, marketed primarily by Teva
Ventolin HFA (Albuterol Sulfate)	MDI	~30%	Dominates MDI segment
Proventil HFA / Ventolin (Albuterol)	MDI	~20%	Patent expiry led to generic competition
Other DPIs (Flovent Diskus, Breo Ellipta)	DPI	~15%	Focused on corticosteroids and long-acting agents

Key Differentiators:

• Delivery Method: ProAir Respiclick is a dry powder inhaler, favored for certain patient populations.
• Pricing: Slight premium over generics but competitive within inhaler segments.
• Patent & Exclusivity: Patents expired in 2019, opening pathways for generics; however, Teva’s formulation maintains brand loyalty.

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4. Regulatory and Reimbursement Dynamics

FDA Approvals and Labeling

• Approved for ages ≥12 years in the U.S., with expanded indications for pediatric use in recent years.
• Post-approval studies and REMS (Risk Evaluation and Mitigation Strategies) ensure safety.

Reimbursement Trends

• Medicare Part D and commercial insurers favor inhalers with proven adherence benefits.
• Increased reimbursement for innovative devices aligns with rising drug costs.

Evolving Policies

• FDA’s push to replace metered-dose inhalers with lower-GWP (Global Warming Potential) alternatives aligns with ProAir Respiclick’s DPI platform.
• Inflation reduction policies could influence drug pricing strategies.

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5. Financial Trajectory and Revenue Projections

Historical Financial Performance

Year	U.S. Sales (Approx.)	Growth Rate	Remarks
2019	~$950 million	—	Introduction of new formulations and increased marketing
2020	~$1.1 billion	15.8%	Boosted by COVID-19 respiratory symptoms awareness
2021	~$1.2 billion	9.1%	Maintains steady growth amidst generic competition

Projected Trends (2023-2028)

Year	Estimated U.S. Sales	Compound Annual Growth Rate (CAGR)	Drivers
2023	~$1.3 billion	3-5%	Market penetration, new physician preferences
2024	~$1.36 billion		Increased adoption due to formulary positioning
2025	~$1.45 billion		Entry of biosimilars and generics
2026-2028	~$1.5-$1.6 billion		Aging population, regulatory incentives

Influencing Factors:

• Entry of generics could pressure pricing and margins.
• Novel inhaler devices and digital health integrations could justify premium positioning.
• Patient adherence improvements with Respiclick's ease-of-use may favor sustained growth.

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6. Challenges and Risks

Challenge / Risk	Impact	Mitigation Strategies
Generic Competition	Revenue erosion	Differentiation via digital features, patents
Market Saturation	Slower growth	Geographic expansion, pediatric indication studies
Regulatory Changes	Price control, formulary restrictions	Active engagement in policy dialogues
Technological Obsolescence	Reduced market relevance	Innovation in inhaler design, digital health

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7. Comparison with Competitors

Aspect	ProAir Respiclick	Ventolin HFA	Breo Ellipta (GSK)	Fluticasone DPI
Delivery Type	DPI	MDI	DPI	DPI
Age Indication	≥12 years	≥4 years	≥18 years	≥4 years
Market Share (2022)	~35%	~30%	~12%	~8%
Price Range (per inhaler)	~$80	~$70	~$150	~$60

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8. Future Opportunities

• Digital Innovation: Integrate Bluetooth and digital sensors for adherence tracking.
• Expanded Indications: Pursuing pediatric and COPD-specific approvals.
• Geographic Expansion: Enter European and Asian markets with tailored marketing.
• Combination Therapies: Develop fixed-dose combinations integrating beta-agonists with corticosteroids.

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Key Takeaways

• The respiratory therapeutics market, particularly for inhaled bronchodilators like ProAir Respiclick, is projected to grow steadily driven by disease prevalence and technological innovation.
• ProAir Respiclick's positioning within the DPI market offers advantages in patient adherence and environmental compliance.
• Patent expiries have introduced generic challenges, yet brand loyalty and digital innovation provide avenues for sustained revenue.
• Regulatory policies and formulary preferences favor DPI devices, shaping future sales trajectories.
• Competition from generics and alternative delivery systems necessitates continuous innovation and strategic market expansion.

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FAQs

Q1: How does the patent expiry affect ProAir Respiclick’s market share?

A1: Patent expiry in 2019 opened the market to generics, exerting downward pressure on prices. However, brand loyalty, digital features, and regulatory exclusivities have helped maintain a significant market share.

Q2: What role do digital features play in the future of ProAir Respiclick?

A2: Digital integration enhances adherence, provides data analytics, and can justify premium pricing, thereby differentiating the product amidst increasing generic competition.

Q3: Will upcoming environmental regulations impact ProAir Respiclick?

A3: Yes. As policies favor low-GWP inhalers, DPIs like Respiclick are positioned advantageously, potentially driving market growth.

Q4: How does ProAir Respiclick compare to other inhalers in terms of patient adherence?

A4: DPIs generally have higher adherence rates due to ease of use and fewer propellants. Respiclick's design further improves the patient experience.

Q5: What are the key growth drivers for ProAir Respiclick in the next five years?

A5: Rising respiratory disease prevalence, technological innovations, environmental policies favoring DPIs, and geographic expansion constitute major growth drivers.

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References

[1] Global COPD Drugs Market – MarketsandMarkets, 2022
[2] Global Asthma Drugs Market – Fortune Business Insights, 2022
[3] IQVIA, U.S. Respiratory Drugs Data, 2022
[4] CDC, Asthma Data & Statistics, 2022
[5] American Lung Association, COPD Burden Report, 2022
[6] Grand View Research, DPI Market Trends, 2022

Note: All figures are estimates based on market research reports and industry sources as of 2022-2023 and may shift with ongoing market developments.