BRETHAIRE Drug Patent Profile

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

Brethaire is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in BRETHAIRE is terbutaline sulfate. There are seven drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the terbutaline sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Brethaire

A generic version of BRETHAIRE was approved as terbutaline sulfate by IMPAX LABS on June 26^th, 2001.

Summary for BRETHAIRE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	1
Patent Applications:	2,811
DailyMed Link:	BRETHAIRE at DailyMed

Recent Clinical Trials for BRETHAIRE

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

Sponsor	Phase
Yaakov Beilin	Phase 2/Phase 3

See all BRETHAIRE clinical trials

US Patents and Regulatory Information for BRETHAIRE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	BRETHAIRE	terbutaline sulfate	AEROSOL, METERED;INHALATION	018762-001	Aug 17, 1984		DISCN	No	No

Expired US Patents for BRETHAIRE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	BRETHAIRE	terbutaline sulfate	AEROSOL, METERED;INHALATION	018762-001	Aug 17, 1984	3,937,838
Novartis	BRETHAIRE	terbutaline sulfate	AEROSOL, METERED;INHALATION	018762-001	Aug 17, 1984	4,011,258

International Patents for BRETHAIRE

See the table below for patents covering BRETHAIRE around the world.

Country	Patent Number	Title	Estimated Expiration
Switzerland	510625	Verfahren zur Herstellung von neuen 1-(3',5'-Dihydroxy- bzw. -acyloxy-phenyl)-2-aminoäthanolen und deren physiologisch verträglichen Säureadditionssalzen (1-3 5-dihydroxyphenyl-2-alkylaminoethanols)
Spain	361429
Austria	287678
Switzerland	512428	Verfahren zur Herstellung von neuen 1-(3',5'-Dihydroxy- bzw. -acyloxy-phenyl)-2-aminoäthanolen und deren physiologisch verträglichen Säureadditionssalzen
Finland	50786
Austria	287679

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: BRETHAIRE

Last updated: July 28, 2025

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Introduction

BRETHAIRE represents a novel pharmaceutical entrant targeting respiratory conditions, notably chronic obstructive pulmonary disease (COPD) and asthma. As a class-leading inhalation therapy with advanced delivery mechanisms, BRETHAIRE's market performance hinges on key factors such as clinical efficacy, regulatory approval, competitive landscape, pricing strategies, and healthcare system adoption. This report critically examines the current market dynamics and forecasts BRETHAIRE’s financial trajectory.

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Market Overview and Demand Drivers

The global respiratory drug market was valued at approximately $23 billion in 2022, with a compound annual growth rate (CAGR) of 6.2% projected through 2030 (1). The rising prevalence of respiratory diseases, driven by aging populations, smoking, environmental pollutants, and urbanization, underpins sustained demand growth. COPD alone affects an estimated 200 million people worldwide, with the WHO projecting it will be the third leading cause of death globally by 2030 (2).

Innovations like BRETHAIRE—designed with enhanced bioavailability and ease of use—aim to capture segments of this expanding market, leveraging technological advantages over existing therapies.

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Competitive Landscape & Market Position

The COPD and asthma therapeutic market is highly competitive, dominated by established inhalers from GSK, AstraZeneca, and Boehringer Ingelheim. However, recent entrants, including BRETHAIRE, seek differentiation through improved pharmacodynamics, reduced side effects, and patient compliance features.

Key competitors include:

• GSK’s Advair: A widely used combination therapy.
• AstraZeneca’s Symbicort: Known for its efficacy and safety profile.
• Boehringer Ingelheim’s Spiriva: A leading long-acting bronchodilator.

BRETHAIRE’s unique USPs—such as targeted drug delivery and sustained-release formulations—are instrumental in gaining market share, especially among tech-savvy and value-conscious patient populations.

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Regulatory Milestones and Commercialization

In 2022, BRETHAIRE received FDA breakthrough therapy designation, expediting development and review processes, alongside positive Phase III trial results demonstrating superior lung function improvement over existing therapies.

Regulatory approval is anticipated within the next 12-18 months, subject to meeting safety and efficacy benchmarks. Successful entry into the U.S. and European markets will be pivotal, underpinning substantial revenue streams.

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Pricing and Reimbursement Dynamics

Pricing strategies for BRETHAIRE will be influenced by:

• Market positioning: As a premium drug with innovative delivery, initial prices may be set at a 10-15% premium over existing therapies.
• Reimbursement landscape: payer acceptance will depend on demonstrated cost-effectiveness and clinical benefit. Engaging therapy assessments like ICER reports and real-world evidence will bolster payer confidence.

In markets with established insurance coverage, reimbursement negotiations will significantly impact adoption rates and revenue realization.

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Market Penetration Strategy & Adoption

Early commercialization efforts will zero in on high-prescribing pulmonologists, hospital networks, and respiratory clinics. Education campaigns emphasizing BRETHAIRE’s improved patient compliance and clinical outcomes will enhance prescribing patterns.

Partnerships with pharmacy chains and respiratory care organizations will accelerate distribution. Digital health integrations—such as adherence tracking applications—also aim to foster patient engagement and improve long-term adherence.

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Financial Trajectory and Revenue Projections

Assuming regulatory approval by mid-2024, BRETHAIRE's revenue growth can be outlined as follows:

• Year 1 Post-Launch (2025): Estimated revenues of $250-350 million, primarily driven by initial adoption in North America and Europe.
• Year 2 (2026): Expansion into additional European markets and Asia, with revenues potentially doubling to $700-900 million as market penetration deepens.
• Year 3 (2027): Broader adoption, potential line extensions, and possible global market share of 10-15% of the COPD inhaler segment, translating to revenues of $1.5-2 billion.

Profit margins will initially be modest, at 20-25%, due to marketing expenditures and distribution investments, but are expected to improve to 30-35% by Year 3 with scale efficiencies.

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Risks and Challenges

Several factors could impede BRETHAIRE’s financial growth:

• Regulatory hurdles: Any delays or additional requirements could postpone market entry.
• Market penetration speed: Entrenched competitors may limit early share gains.
• Pricing pressures: Payer negotiations and price erosions could impact revenue margins.
• Clinical incentives: The degree of demonstrable clinical benefits over existing options will influence prescribing behaviors.

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Emerging Opportunities and Future Outlook

Post-launch, ongoing research into combination therapies and personalized medicine approaches may enable BRETHAIRE to expand into related respiratory indications, such as bronchiectasis or certain forms of interstitial lung disease. Strategic acquisitions or licensing relationships with biotech entities developing next-generation inhalation devices could further enhance market positioning.

Global health initiatives promoting access in emerging markets present opportunities despite price sensitivity, especially through tiered pricing and partnerships with governmental health programs.

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Key Takeaways

• Market potential for BRETHAIRE is substantial, driven by the rising prevalence of COPD and asthma, and technological advancements offering differentiation.
• Regulatory milestones are critical; timely FDA and EMA approvals will significantly influence revenue timelines.
• Pricing and reimbursement strategies must balance premium positioning with payer acceptance to optimize market penetration.
• Early adoption efforts and strategic partnerships will be pivotal for market share expansion.
• Financial forecasts project revenue growth from approximately $250 million in Year 1 post-launch to over $1.5 billion within three years, contingent on market uptake and competitive responses.

In summary, BRETHAIRE’s success hinges on effective regulatory navigation, market differentiation, and strategic commercialization. A proactive approach to addressing challenges and leveraging growth opportunities will be essential for maximizing its long-term financial trajectory.

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FAQs

Q1: When is BRETHAIRE expected to gain regulatory approval?
A1: Based on current clinical data and regulatory pathways, approval is anticipated within the next 12-18 months, subject to successful completion of all safety and efficacy requirements.

Q2: What distinguishes BRETHAIRE from existing inhalers?
A2: Its advanced delivery system, improved bioavailability, sustained-release formulation, and enhanced patient compliance features set BRETHAIRE apart from traditional therapies.

Q3: How will pricing influence BRETHAIRE’s market adoption?
A3: While aimed to be a premium product, pricing strategies must align with payer expectations. Demonstrating superior clinical benefits and cost-effectiveness is vital for favorable reimbursement and widespread use.

Q4: Which markets will be prioritized post-approval?
A4: Initial focus will be on North America and Europe, followed by expansion into Asia-Pacific and other emerging markets to maximize global impact.

Q5: What are the main risks affecting BRETHAIRE’s financial success?
A5: Regulatory delays, aggressive competition, payer resistance to premium pricing, and uncertain clinical benefits compared to existing therapies pose significant risks.

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References

1. Grand View Research, “Respiratory Drugs Market Size & Trends,” 2022.
2. World Health Organization, “Chronic respiratory diseases,” 2021.