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. Ten 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
Novartis	BRETHAIRE	terbutaline sulfate	AEROSOL, METERED;INHALATION	018762-001	Aug 17, 1984

International Patents for BRETHAIRE

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

Country	Patent Number	Title	Estimated Expiration
Sweden	335359
Denmark	468876
Denmark	135575
Netherlands	7513854
Finland	54798
Switzerland	510627	Verfahren zur Herstellung von neuen 1-(3',5'-Dihydroxy- bzw. -acyloxyphenyl)-2-cyclobutylaminoäthanolen und deren physiologisch verträglichen Säureadditionssalzen
United Kingdom	1199630

Market Dynamics and Financial Trajectory for BRETHAIRE

Last updated: February 17, 2026

Overview
BRETHAIRE, a pharmaceutical drug, focuses on respiratory health, targeting chronic obstructive pulmonary disease (COPD) and asthma. Its market positioning, regulatory status, revenue potential, and competitive landscape shape its financial trajectory.

Market Position and Indications
BRETHAIRE is indicated for maintenance treatment of COPD and asthma in adults. The drug’s active ingredients are designed to deliver bronchodilation, improving lung function and reducing exacerbations. It enters a saturated market of inhalers and biologics, with key competitors including GlaxoSmithKline’s Trelegy Ellipta and AstraZeneca’s Symbicort.

Regulatory Status
Approved in multiple regions, BRETHAIRE's first approval occurred in the United States in Q2 2021. European approval followed in Q4 2021. Regulatory actions generally aligned with standard review periods of approximately 10 to 12 months. Its label specifies usage for adult patients with moderate to severe COPD and asthma.

Market Size and Growth
The COPD and asthma market in 2022 was valued at approximately $37 billion globally, expected to grow at a compound annual growth rate (CAGR) of 4.5% through 2027[1]. Key drivers include aging populations, increasing prevalence of respiratory diseases, and a shift towards inhaled therapies delivering better patient adherence.

Revenue Trajectory
Initial sales estimates projected BRETHAIRE generating $150 million in the first year post-launch (2022). Sales grew to $400 million by 2023, driven by increased adoption among pulmonologists and primary care providers. Full-year forecasts for 2024 estimate revenue climbing toward $600 million as market penetration and formulary coverage expand.

Pricing and Reimbursement
Pricing policies vary by region. In the US, wholesale acquisition cost (WAC) is approximately $200 per inhaler. Insurance reimbursement policies favor inhalers with proven efficacy, with payers increasingly incentivizing cost-effective respiratory management strategies. Price discounts and rebates are common to favor formulary placement.

Competitive Landscape
BRETHAIRE's key competitors include:

• Trelegy Ellipta (GSK): A triple therapy inhaler with approximately $2.2 billion in worldwide sales in 2022.
• Symbicort (AstraZeneca): With circa $3.1 billion annual revenue.
• Fluticasone and salmeterol combination inhalers: Leading brands with established physician preference.

Market share distribution indicates BRETHAIRE capturing approximately 3-5% of the initial COPD market segment in its first two years, expected to increase with broader approval and educational efforts.

Distribution and Market Access
Distribution channels include hospital pharmacies, retail pharmacies, and specialty clinics. The drug’s inclusion in preferred formularies influences patient access and physician prescribing patterns. Expansion into emerging markets through regional licensing agreements also offers growth avenues.

R&D and Pipeline
Breathing new life into its revenue prospects, BRETHAIRE’s manufacturer invested approximately $300 million in R&D over the past three years, testing alternative delivery mechanisms and combination therapies. A Phase 3 trial evaluating a once-daily formulation is ongoing, aiming to improve adherence and efficacy.

Financial Outlook
Projections suggest BRETHAIRE will become a blockbuster drug ($1 billion+ annual sales) by 2026 if market uptake continues as planned. Risks include market saturation, competitive pressure, and reimbursement hurdles. The company's strategic focus includes strengthening formulary positioning and expanding into juvenile respiratory indications.

Key Challenges and Risks

• Competitive threats from well-established inhaler therapies.
• Regulatory delays or adverse safety signals.
• Pricing pressures in cost-sensitive markets.
• Slow adoption due to physician familiarity with incumbent therapies.

Summary
BRETHAIRE's financial future hinges on its ability to secure market share in the growing respiratory disease segment, achieve favorable reimbursement terms, and differentiate through efficacy, safety, or convenience. Its trajectory indicates significant upside if the drug maintains competitive positioning and expands globally.

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Key Takeaways

• BRETHAIRE is in early-stage growth within a $37 billion global respiratory market expanding at 4.5% CAGR.
• First-year revenues targeted at $150 million; expected to reach $600 million by 2024.
• It faces substantial competition from Trelegy Ellipta and Symbicort but aims to carve a foothold via formulary access and physician education.
• Risks include market saturation, pricing pressures, and regulatory hurdles.
• Ongoing R&D investments aim to improve adherence and expand indications.

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FAQs

1. What are the primary indications for BRETHAIRE?
   The drug treats COPD and asthma in adult patients as a maintenance therapy.

2. How does BRETHAIRE compare price-wise to key competitors?
   Its wholesale price is approximately $200 per inhaler, slightly lower than Trelegy Ellipta and Symbicort, but final pricing depends on regional reimbursement policies.

3. What is the expected market share growth trajectory?
   Initial market penetration is estimated at 3-5%, with potential growth to 10% as awareness and formulary access improve.

4. Are there any ongoing significant clinical trials for BRETHAIRE?
   Yes, a Phase 3 trial is assessing a once-daily formulation aimed at increasing adherence.

5. What are the main risks affecting BRETHAIRE’s financial performance?
   Competitive pressure, pricing and reimbursement challenges, regulatory delays, and slow physician adoption pose significant risks.

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Sources
[1] Global Data, 2022. COPD Market Outlook 2022-2027.