BRETHINE Drug Patent Profile

Which patents cover Brethine, and what generic alternatives are available?

Brethine is a drug marketed by Pharmacare and Ani Pharms and is included in two NDAs.

The generic ingredient in BRETHINE 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 Brethine

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

Summary for BRETHINE

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	2
Patent Applications:	4,569
DailyMed Link:	BRETHINE at DailyMed

Recent Clinical Trials for BRETHINE

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

Sponsor	Phase
Yaakov Beilin	Phase 2/Phase 3
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Phase 1
Jaeb Center for Health Research	Phase 1

See all BRETHINE clinical trials

US Patents and Regulatory Information for BRETHINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmacare	BRETHINE	terbutaline sulfate	INJECTABLE;INJECTION	018571-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Ani Pharms	BRETHINE	terbutaline sulfate	TABLET;ORAL	017849-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Ani Pharms	BRETHINE	terbutaline sulfate	TABLET;ORAL	017849-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	No

Expired US Patents for BRETHINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pharmacare	BRETHINE	terbutaline sulfate	INJECTABLE;INJECTION	018571-001	Approved Prior to Jan 1, 1982
Ani Pharms	BRETHINE	terbutaline sulfate	TABLET;ORAL	017849-002	Approved Prior to Jan 1, 1982
Ani Pharms	BRETHINE	terbutaline sulfate	TABLET;ORAL	017849-001	Approved Prior to Jan 1, 1982
Pharmacare	BRETHINE	terbutaline sulfate	INJECTABLE;INJECTION	018571-001	Approved Prior to Jan 1, 1982
Ani Pharms	BRETHINE	terbutaline sulfate	TABLET;ORAL	017849-001	Approved Prior to Jan 1, 1982
Ani Pharms	BRETHINE	terbutaline sulfate	TABLET;ORAL	017849-002	Approved Prior to Jan 1, 1982

International Patents for BRETHINE

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

Country	Patent Number	Title	Estimated Expiration
Denmark	468876
Denmark	135577
Netherlands	6714191
Switzerland	512428	Verfahren zur Herstellung von neuen 1-(3',5'-Dihydroxy- bzw. -acyloxy-phenyl)-2-aminoäthanolen und deren physiologisch verträglichen Säureadditionssalzen
Norway	124723
France	8011

Market Dynamics and Financial Trajectory for BRETHINE (Terbutaline Sulfate)

Last updated: July 28, 2025

Introduction

BRETHINE, with the active pharmaceutical ingredient (API) terbutaline sulfate, is a bronchodilator primarily used to manage asthma and chronic obstructive pulmonary disease (COPD). It is recognized for its rapid onset and effectiveness in relieving bronchospasm, making it a vital medication in respiratory care. This analysis explores current market trends, competitive landscape, regulatory considerations, and the projected financial trajectory of BRETHINE over the upcoming years.

Market Overview

Historical Context and Usage

Terbutaline sulfate was introduced in the 1960s and gained prominence as an inhaled beta-2 adrenergic agonist. Its primary indications include acute bronchospasm relief, preterm labor management, and prevention of exercise-induced bronchospasm (EIB). Over decades, the drug has maintained stable demand, especially within primary care and hospital settings.

Current Market Size

Globally, the respiratory drugs market was valued at approximately US$45 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 4.2% until 2030 [1]. While BRETHINE's market share remains modest relative to inhaled corticosteroids and newer agents, it retains niche importance for specific indications like preterm labor and acute asthma exacerbations.

Geographical Distribution

The North American market dominates due to high prevalence of respiratory diseases and well-established healthcare infrastructure. Asia-Pacific exhibits the fastest growth, driven by rising respiratory disease incidence, urbanization, and increasing healthcare access. Europe maintains steady demand, especially in rural and primary care contexts.

Market Dynamics

Competitive Landscape

The landscape is characterized by a mix of branded formulations, generic alternatives, and inhaler devices. Key competitors include:

• Generic manufacturers: Offer cost-effective alternatives, capturing price-sensitive segments.
• Innovators: Focus on inhalation device improvements and combination therapies.
• Emerging therapies: Long-acting beta-agonists (LABAs) and inhaled corticosteroids (ICS) increasingly replace older agents like terbutaline.

Despite patent expirations, BRETHINE retains relevance in specific niches, notably preterm labor, where its off-label use persists, regulated by regional guidelines.

Regulatory Environment

Regulatory authorities such as the FDA (U.S.), EMA (Europe), and PMDA (Japan) oversee approval, labeling, and post-market surveillance. In several regions, BRETHINE's label is limited to specific indications due to safety concerns, notably cardiovascular side effects. The approval landscape influences market access and formulary inclusion, thereby impacting sales.

Pricing and Reimbursement

Pricing remains sensitive to the generic status of BRETHINE. Reimbursable by government healthcare systems and private insurers, reimbursement policies significantly influence prescribing patterns. High out-of-pocket costs can hinder adoption, especially in low- and middle-income countries.

Technological Innovations

Advancements in inhaler devices, such as dry powder inhalers and nebulizers, affect BRETHINE’s administration efficacy and patient adherence. However, newer bronchodilators offer longer duration and fewer side effects, challenging BRETHINE’s market share.

Pandemic Effect

The COVID-19 pandemic heightened awareness of respiratory therapies, leading to increased prescriptions of bronchodilators. Yet, supply chain disruptions and resource reallocation temporarily affected manufacturing and distribution, slightly dampening market growth.

Financial Trajectory

Revenue Trends

Historical sales of BRETHINE have experienced plateauing trends, owing to patent expirations and competition from generics. In the U.S., the drug’s annual sales hover around US$50–$70 million, with global revenues estimated at approximately US$150 million [2].

Forecasting Future Revenue

Given anticipated market saturation and competition, revenues are projected to decline marginally by 2-4% annually over the next five years unless new indications or formulations are introduced. Conversely, in emerging markets, increased adoption and healthcare penetration could offset declines in mature markets.

Drivers of Growth

• Expansion into preterm labor management: If regulatory bodies approve additional indications, sales could see a significant uptick.
• Formulation improvements: Introducing combination inhalers or enhanced delivery methods can boost patient adherence and thereby sales.
• Regulatory approvals in emerging markets: Expanding access can foster revenue growth in regions with rising respiratory disease burdens.

Risks to Financial Stability

• Market competition: Preference for newer, long-acting agents could erode BRETHINE's market share.
• Regulatory restrictions: Safety concerns or labeling changes might diminish prescribing confidence.
• Generic erosion: Price competition from generics can compress margins, especially once multiple manufacturers enter the market.

Investment and R&D Outlook

Investing in inhaler technology and expanding therapeutic indications constitutes vital strategies. R&D efforts focused on reducing side effects and improving delivery can position BRETHINE favorably against newer therapies.

Strategic Implications

To capitalize on the market’s potential, stakeholders should consider:

• Market differentiation: Emphasize niche indications where BRETHINE demonstrates superior efficacy or safety.
• Regulatory engagement: Work to secure approvals or label expansions for additional indications, especially in preterm labor.
• Pricing strategies: Optimize for reimbursement environments, balancing affordability and profitability.
• Partnerships: Collaborate with device manufacturers for innovative delivery systems.

Conclusion

BRETHINE’s market remains stable within certain niches, particularly in acute care and preterm labor management. While competitive pressures from newer therapies and generics pose challenges, strategic focus on formulation innovation, indication expansion, and emerging markets could sustain and marginally grow its financial trajectory. Continuous monitoring of regulatory landscape and technological advancements will be critical to navigate evolving market dynamics effectively.

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Key Takeaways

• BRETHINE maintains a niche market position, with global revenues around US$150 million, primarily driven by acute respiratory indications and preterm labor.
• Competitive pressures from generics and newer long-acting bronchodilators forecast a slight revenue decline, barring new approvals or formulations.
• Emerging markets offer growth opportunities due to increasing respiratory disease prevalence and expanding healthcare access.
• Technological advancements in inhalation devices can enhance patient adherence and differentiate BRETHINE in competitive environments.
• Regulatory considerations, safety concerns, and reimbursement policies substantially influence market trajectory.

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FAQs

Q1: What are the primary current indications for BRETHINE?
A: Originally approved for bronchospasm relief in asthma and COPD, BRETHINE is also used off-label for preterm labor management in certain regions.

Q2: How does the entry of generic versions affect BRETHINE’s market?
A: Generics generally lead to reduced pricing and market share erosion, especially in cost-sensitive regions, impacting revenue and profitability.

Q3: Are there ongoing developments to expand BRETHINE’s indications?
A: While regulatory approval efforts focus on existing indications, exploration of preterm labor uses has potential for expansion depending on clinical trial outcomes and regional approval processes.

Q4: What technological innovations could influence BRETHINE’s market in the future?
A: Advances such as improved inhaler devices and combination therapies could improve efficacy and patient adherence, offering competitive advantages.

Q5: What are the key risks facing BRETHINE’s market sustainability?
A: Key risks include increased competition, regulatory restrictions due to safety concerns, and shifts toward newer long-acting bronchodilator therapies.

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References

[1] MarketsandMarkets. Respiratory Drugs Market, 2022.
[2] IMS Health Data. Global Bronchodilator Sales, 2022.