PROAIR DIGIHALER Drug Patent Profile

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

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

The generic ingredient in PROAIR DIGIHALER 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 Digihaler

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

Summary for PROAIR DIGIHALER

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	1
Patent Applications:	5,216
Drug Prices:	Drug price information for PROAIR DIGIHALER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PROAIR DIGIHALER
What excipients (inactive ingredients) are in PROAIR DIGIHALER?	PROAIR DIGIHALER excipients list
DailyMed Link:	PROAIR DIGIHALER at DailyMed

See drug prices for PROAIR DIGIHALER

Recent Clinical Trials for PROAIR DIGIHALER

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of North Carolina, Chapel Hill	Early Phase 1
Wake Forest University Health Sciences	Early Phase 1
Teva Branded Pharmaceutical Products R&D, Inc.	Early Phase 1

See all PROAIR DIGIHALER clinical trials

Pharmacology for PROAIR DIGIHALER

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

US Patents and Regulatory Information for PROAIR DIGIHALER

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 DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018		DISCN	Yes	No

Expired US Patents for PROAIR DIGIHALER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018

International Patents for PROAIR DIGIHALER

See the table below for patents covering PROAIR DIGIHALER 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

Market Dynamics and Financial Trajectory for PROAIR DIGIHALER: A Comprehensive Analysis

Last updated: July 29, 2025

Introduction

The pharmaceutical landscape is characterized by rapid technological advancements, evolving regulatory frameworks, and shifting consumer demands. Among inhaler therapies, PROAIR DIGIHALER (albuterol sulfate inhalation aerosol) represents a significant innovation, integrating digital health capabilities with traditional bronchodilator therapy. This analysis explores the current market dynamics, competitive positioning, and projected financial trajectory of PROAIR DIGIHALER within the broader respiratory medication sector.

Market Overview

The global respiratory disease market has experienced sustained growth due to increasing prevalence of asthma and COPD. According to the Global Initiative for Asthma (GINA), over 300 million individuals globally suffer from asthma, with numbers expected to escalate driven by urbanization, pollution, and aging populations [1]. COPD affects over 250 million people worldwide, contributing significantly to respiratory disease burden [2].

In this context, inhaled bronchodilators like albuterol (salbutamol) are frontline therapies. The integration of digital technologies—such as PROAIR DIGIHALER—aims to optimize adherence, dosing accuracy, and real-time monitoring, aligning with trends toward personalized and connected healthcare.

Current Market Size

The global inhaler device market was valued at approximately USD 9 billion in 2022, with a compound annual growth rate (CAGR) of 4-6%, driven by rising respiratory disease prevalence and technological integration [3]. The digital inhaler segment, although nascent, is projected to expand rapidly, potentially surpassing USD 2 billion by 2027.

Therapeutic Market Segmentation

The therapeutic demand for bronchodilators is segmented as follows:

• Asthma: Driving significant adoption due to its prevalence in pediatric and adult populations.
• COPD: Accounting for a substantial share due to chronic disease management needs.

Technological enhancements such as PROAIR DIGIHALER target adherence improvements, a critical metric in respiratory therapies, which historically suffers from patient non-compliance rates exceeding 50% [4].

Market Drivers

Growing Prevalence of Respiratory Diseases

Rising incidence rates of asthma and COPD directly expand the potential patient base for inhaler therapies, including digital variants.

Shift Toward Digital Health

The global digital health market is projected to grow at a CAGR of approximately 28%, with connected inhalers playing an increasingly pivotal role [5]. The ability to monitor usage patterns and adherence via digital devices enhances treatment outcomes and reduces hospitalizations.

Regulatory Favorability

Regulatory agencies such as the FDA and EMA are increasingly supportive of digital health innovations, providing clear pathways for approval and reimbursement of digital inhalers like PROAIR DIGIHALER.

Healthcare Cost Savings

Digital inhalers facilitate better disease management, reducing emergency visits and hospital stays, aligning with payer priorities to control costs.

Market Challenges

• Regulatory and Reimbursement Uncertainties: While regulatory pathways are clearer, reimbursement policies for digital inhalers are evolving and vary across markets.
• Patient Acceptance: Adoption depends on patient comfort with digital devices, necessitating educational initiatives.
• Intellectual Property Risks: Patent disputes or expiration could impact projected exclusivity periods.

Competitive Landscape

The digital inhaler market comprises established players such as Propeller Health, Adherium, and Teva Pharmaceuticals. PROAIR DIGIHALER distinguishes itself through FDA approval, integration with existing respiratory therapy protocols, and widespread familiarity due to the PROAIR brand's legacy.

Other key competitors include:

• Respiro Digital Inhaler: Focused on smart inhaler technology with robust data analytics.
• Propeller Health: Offers digital sensors compatible with multiple inhalers, emphasizing data transparency.
• Teva's DigiHaler: A notable digital inhaler with similar integration aims.

Given these dynamics, PROAIR DIGIHALER's competitive advantage hinges on brand recognition, digital efficacy, and payer partnerships.

Financial Trajectory

Revenue Projections

Initial launch revenues are expected to be modest, primarily generated through early adopter prescribers and digital health reimbursements. However, with increasing adoption and expanded payer coverage, revenues could reach approximately USD 300-500 million annually within 3-5 years.

Pricing Strategy

Premium pricing is anticipated due to technology integration and added value. Estimated prices may range from USD 35-50 per inhaler device, compared to traditional inhalers priced around USD 20-30.

Cost Structure

Development costs encompass R&D, regulatory filings, manufacturing, and marketing. Economies of scale will eventually reduce per-unit costs. Additionally, ongoing expenses include digital platform maintenance and data management.

Profitability Outlook

With increasing market penetration, PROAIR DIGIHALER could achieve EBITDA margins of 20-30%, aligning with technological product lines in the pharmaceutical industry.

Market Expansion Opportunities

• Geographic Expansion: Launch in Europe and Asia-Pacific markets, where respiratory disease burden is high.
• Therapeutic Expansion: Incorporate other medications into the digital platform, such as corticosteroids or combination therapies.
• Data Monetization: Offer anonymized usage data to payers and health systems to inform clinical decisions.

Regulatory and Reimbursement Outlook

The FDA's Digital Health Innovation Action Plan underpins a favorable regulatory environment. Reimbursement policies are increasingly accommodating digital inhalers, especially when backed by real-world evidence demonstrating improved adherence and outcomes [6]. Strategic partnerships with payers could accelerate adoption and revenue growth.

Conclusion

The trajectory of PROAIR DIGIHALER is promising, driven by escalating respiratory disease prevalence and the digital health revolution. While challenges exist, strategic positioning, regulatory support, and evolving reimbursement frameworks suggest substantial market acceptance and revenue growth over the next five years. Continuous innovation and data-driven strategies will be essential for maximizing financial returns.

Key Takeaways

• The global respiratory market, especially digital inhaler segments, is poised for significant growth, presenting opportunities for PROAIR DIGIHALER.
• Adoption depends on effective integration with healthcare providers, payers, and patient engagement strategies.
• Early revenue streams will likely be modest but set the foundation for scalable growth with expanded market access.
• Regulatory and reimbursement landscapes are becoming increasingly supportive of digital health innovations.
• Strategic expansion into new markets and therapeutic areas can enhance profitability and market share.

FAQs

1. How does PROAIR DIGIHALER differentiate from traditional inhalers?
It incorporates digital sensors that track usage, provide real-time data to patients and providers, and support adherence through connected health platforms.

2. What are the main barriers to market adoption?
Key barriers include patient acceptance of digital devices, reimbursement policies, and regulatory approvals in different regions.

3. What is the expected timeline for revenue growth?
Initial revenues may be modest within the first year post-launch, with substantial growth projected over 3-5 years as adoption accelerates.

4. How does digital integration affect pricing and profitability?
Digital features allow for premium pricing due to added value, which, combined with scale efficiencies, can enhance profitability margins.

5. What strategic partnerships could accelerate PROAIR DIGIHALER’s market penetration?
Collaborations with payers, healthcare providers, and digital health platforms are critical for widespread adoption and sustainable revenue streams.

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Sources:

[1] GINA Report, 2022. Global Asthma Statistics.
[2] World Health Organization, 2021. Chronic Respiratory Diseases.
[3] MarketsandMarkets, 2022. Inhaler Devices Market Analysis.
[4] WHO, 2019. Adherence to Asthma Medication.
[5] Grand View Research, 2022. Digital Health Market Outlook.
[6] FDA, 2021. Digital Health Innovation Initiatives.