BRICANYL Drug Patent Profile

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

Bricanyl is a drug marketed by Sanofi Aventis Us and is included in three NDAs.

The generic ingredient in BRICANYL 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 Bricanyl

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

Summary for BRICANYL

US Patents:	0
Applicants:	1
NDAs:	3

US Patents and Regulatory Information for BRICANYL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sanofi Aventis Us	BRICANYL	terbutaline sulfate	AEROSOL, METERED;INHALATION	018000-001	Mar 19, 1985		DISCN	No	No
Sanofi Aventis Us	BRICANYL	terbutaline sulfate	TABLET;ORAL	017618-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Sanofi Aventis Us	BRICANYL	terbutaline sulfate	INJECTABLE;INJECTION	017466-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Sanofi Aventis Us	BRICANYL	terbutaline sulfate	TABLET;ORAL	017618-001	Approved Prior to Jan 1, 1982		DISCN	No	No

International Patents for BRICANYL

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

Country	Patent Number	Title	Estimated Expiration
Denmark	135575
Spain	346131
Finland	54798
Germany	1793759
Austria	288356

Investment Scenario and Fundamentals Analysis for BRICANYL (Terbutaline)

Last updated: February 20, 2026

What is BRICANYL?

BRICANYL is a brand name for terbutaline, a bronchodilator used primarily in the treatment of asthma, chronic bronchitis, and emphysema. It functions by relaxing airway muscles, improving airflow, and relieving bronchospasm. The drug is available in inhaler, tablet, and injectable forms.

Market Overview and Clinical Use

Market Size and Growth

The global respiratory drug market was valued at approximately USD 39 billion in 2022 and is projected to reach USD 54 billion by 2028, growing at a CAGR of roughly 6.5% (Fortune Business Insights, 2023). Within this, bronchodilators constitute nearly 60% of the market, driven by rising prevalence of respiratory diseases.

Key End-Users

• Hospitals
• Specialty clinics
• Pharmacy stores

Drivers

• Increasing prevalence of asthma and COPD
• Rising awareness and diagnosis
• Advances in inhaler technology

Limitations and Challenges

• Competition from newer long-acting bronchodilators
• Regulatory restrictions
• Concerns about side effects and overuse

Competitive Position

Major Competitors

• Albuterol (Ventolin)
• Ipratropium
• Tiotropium

BRICANYL’s Market Status

BRICANYL maintains a significant share in the short-acting bronchodilator segment, especially in developed markets. Its versatility in forms and existing regulatory approvals provide a stable revenue base.

Regulatory and Patent Landscape

Patent Status

Terbutaline's patents have expired in most jurisdictions, enabling generic manufacturing. This leads to price competition and pressure on branded product margins.

Regulatory Landscape

• Approved by the FDA since 1970
• EMA approvals also in place
• Regulatory agencies focus on safety data, especially related to overuse and cardiac side effects

Revenue and Financials

Sales Data

• Estimated global sales of BRICANYL in 2022: USD 350 million
• Approximate annual growth rate since 2018: 2-3% (industry estimates)

Profitability

• Margins are declining due to generic competition
• EBITDA margins estimated at around 20-25% in peak years

R&D and Pipeline

BRICANYL does not currently have significant ongoing R&D activity. The focus is on maintaining existing formulations and expanding into new delivery devices.

Future growth hinges on:

• Developing combination inhalers
• Expanding pediatric indications
• Digital health integrations for adherence

Investment Considerations

Strengths

• Established global market presence
• Multiple formulation options
• Existing regulatory approvals

Weaknesses

• Patent expiration leading to generic competition
• Limited pipeline R&D making growth dependent on existing product performance
• Safety concerns impacting prescribing patterns

Opportunities

• Market expansion in emerging economies
• Product line extension into combination therapies
• Digital health solutions for adherence monitoring

Threats

• Intense generic price competition
• Shift toward long-acting bronchodilators
• Regulatory tightening on safety parameters

Strategic Outlook

Investment in BRICANYL involves balancing its mature market position against its declining margins due to patent expiries. Future value depends on the manufacturer's ability to innovate through device improvements, combination products, or digital health solutions. Risk factors include increasingly aggressive generic competition and evolving safety standards.

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Key Takeaways

• BRICANYL remains a relevant bronchodilator with a significant global presence.
• Revenue is under pressure from patent expiration and generic competition.
• Growth opportunities exist in emerging markets and through product line extensions.
• R&D is limited; future growth relies on incremental innovation rather than pipeline breakthroughs.
• The drug’s safety profile remains critical to market acceptance amidst regulatory scrutiny.

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FAQs

1. How does BRICANYL compare to other bronchodilators in efficacy?
BRICANYL (terbutaline) provides rapid relief but is generally less preferred for long-term management compared to long-acting agents like tiotropium. Its quick onset makes it suitable as a rescue inhaler.

2. What are the main safety concerns associated with BRICANYL?
Risks include cardiac stimulation, tremors, and overuse-related adverse effects, especially in patients with heart conditions.

3. Can the patent expiration impact future sales?
Yes. Patent expiry typically leads to generic entry, price reductions, and sales declines for branded versions.

4. What growth strategies can manufacturers pursue?
Expanding into emerging markets, developing combination inhalers, and integrating digital adherence tools can buffer revenue declines.

5. Are there regulatory risks affecting BRICANYL?
Yes. Increasing safety concerns and regulatory constraints on over-the-counter and prescription use could impact market access.

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References

[1] Fortune Business Insights. (2023). Respiratory Drugs Market Size, Share & Industry Analysis. https://www.fortunebusinessinsights.com

[2] U.S. Food and Drug Administration. (2022). Drug Approvals and Safety. https://www.fda.gov

[3] European Medicines Agency. (2022). Medicines Regulatory Updates. https://www.ema.europa.eu